Patents

A U.S. Patent Application for a "Process for Manipulating the Level of Glycan Content of a Glycoprotein" was published by Amgen on March 21st, 2019. The present invention is a recombinant protein produced by a method for manipulating the fucosylated glycan content on a recombinant protein comprising inoculating a bioreactor with mammalian host cells expressing the recombinant protein, culturing the mammalian host cells in a serum-free, chemically defined cell culture medium; wherein the cell culture medium includes from 10 to 100 ppb copper and from 50 to 1000 nM manganese. Learn More

A U.S. Patent Application for the "Control of Protein Glycosylation by Culture Medium Supplementation and Cell Culture Process Parameters was published by Biogen on March 21st, 2019. The present invention pertains to a cell culture medium comprising media supplements that are shown to control recombinant protein glycosylation and/or cell culture in a controlled or modulated (shifted) temperature to control recombinant protein glycosylation and/or cell culture with controlled or modulated seed density to control recombinant protein glycosylation, and methods of using thereof. Learn More

A U.S. Patent for "Purification of Proteins" was awarded to MilliporeSigma on March 19th, 2019. The present invention relates to a selectively soluble polymer capable of binding to a desired molecule in an unclarified mixture containing various biological materials and the methods of using such a polymer to purify a molecule from such a mixture. The polymer is soluble in the mixture under a certain set of process conditions such as pH or temperature and/or salt concentration and is rendered insoluble and precipitates out of solution upon a change in the process conditions. The polymer is capable of binding to the desired molecule (protein, polypeptide, etc). Learn More

A U.S. Patent Application for "Animal Protein-Free Media for Cultivation of Cells" was published by Baxalta on March 14th, 2019. The present invention relates to animal protein-free cell culture media comprising polyamines and a plant- and/or yeast-derived hydrolysate. The invention also relates to animal protein-free culturing processes, wherein cells can be cultivated, propagated and passaged without adding supplementary animal proteins in the culture medium. These processes are useful in cultivating cells, such as recombinant cells or cells infected with a virus, and for producing biological products by cell culture processes. Learn More

A U.S. Patent for "Overexpression of N-Glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins" was awarded to Amgen on March 12th, 2019. The present invention is a method of regulating the high mannose glycoform content of a recombinant protein during a mammalian cell culture process, comprising: transfecting a mammalian host cell to overexpress a protein that is involved in an N-glycosylation pathway, wherein the protein involved in the N-glycosylation pathway is selected from the group...wherein the mammalian cell culture is perfused using alternating tangential flow (ATF), and wherein the recombinant protein is harvested and purified. Learn More

A U.S. Patent for "Composite Sensor Assemblies for Single Use Bioreactors" was awarded to Finesse on March 12th, 2019. The present invention is a composite sensor assembly for monitoring bio-processes which is suitable for use with a polymeric bioprocess vessel or with downstream equipment, and comprises: i) a port comprising a high surface tension thermoplastic having a hollow tubular portion and a base plate portion, the base plate being fusibly sealable to the bioreactor vessel at a hole in the wall thereof; ii) a generally opaque polymeric monitoring sensor assembly including electrical, and/or optical measurement components. Learn More

A U.S. Patent for a "Compounded Media Powder Formulation and Method of Preparation of Liquid Medium for Cell Culture" was awarded to Bayer on March 12th, 2019. The present invention provides a compounded cell culture medium powder formulation comprising: a basal medium powder and a cell culture media supplement, wherein the cell culture media supplement comprises and one or more salts; one or more growth factors; one or more inorganic ions; an amino acid supplement comprising one or more of asparagine, glutamine, histidine, and serine; one or more buffers; and one or more anti-foaming agents. Learn More

A U.S. Patent Application for "Methods for Continuously Inactivating a Virus During Manufacture of a Protein" was published by Boehringer Ingelheim on March 7th, 2019. The present invention refers to methods for continuously inactivating a virus during manufacture of a protein are provided. Steps include (1) combining, at a single predetermined volumetric ratio, a composition including the protein, and a composition including a virus-inactivation reagent, to obtain a treatment composition having a predetermined property for inactivation of a virus; (2) transferring the treatment composition to a treatment vessel; (3) incubating the treatment composition in the treatment vessel at predetermined conditions... Learn More

A U.S. Patent Application for a "Method for Determining the InVivo Comparability of a Biologic Drug and a Reference Drug" was published by Bioanalytix on March 7th, 2019. The present invention provides a mass-spectroscopic approach for assessing and determining the in vivo comparability of a candidate biologic molecule to a reference biologic molecule. The results can be presented in the form of an in vivo comparability profile, which can serve as a development tool, e.g., as a guide or target for the development of biologies, biosimilars, or gene therapy-based drugs. Learn More

A U.S. Patent for a "Disposable Bioreactor Condenser Bag and Filter Heater" was awarded to GE on March 5th, 2019. The present invention is a system for condensing moisture in a moist gas stream entering or leaving a bioreactor includes a condenser container, the condenser container comprising: an outer wall surface and an inner wall surface, the inner wall surface defining an interior chamber for holding a fluid; and a first fitment attached to the outer wall surface and forming a first port configured to allow the moist gas stream to flow into the interior chamber; a second fitment attached to the outer wall surface and forming a second port configured to allow a dried gas to flow from the interior chamber and out of the second port... Learn More

A U.S. Patent for a "Method of Producing a Polypeptide or Virus of Interest in a Continuous Cell Culture" was awarded to Baxalta on March 5th, 2019. The present invention is a chemostat-like continuous cell culture system that combines certain advantages of perfusion open systems and chemostat open systems to improve the culturing of mammalian cells, e.g., genetically modified cells, particularly in serum-free or chemically-defined media. The continuous culture system described herein involves culturing mammalian cells in a continuous cell culture system, which comprises a cell retention device. Learn More

A U.S. Patent Application for a "Chromatography Ligand Comprising Domain C from Staphylococcus Aureus Protein A for Antibody Isolation" was published by GE on February 28th, 2019. The present invention relates to a chromatography ligand, which comprises Domain C from Staphylococcus protein A (SpA), or a functional fragment or variant thereof. The chromatography ligand presents an advantageous capability of withstanding harsh cleaning in place (CIP) conditions, and is capable of binding Fab fragments of antibodies. The ligand may be provided with a terminal coupling group, such as arginine or cysteine, to facilitate its coupling to an insoluble carrier such as beads or a membrane. Learn More

A U.S. Patent Application for an "Electronically Controlled Diaphragm Pump" was published by Stobbe Pharma on February 28th, 2019. The present invention is an electronically controlled diaphragm pump system that includes a pump housing with a drive gas chamber, a fluid chamber separated by a diaphragm, gas pressure means for providing a drive gas pressure in response to a control signal, and gas under-pressure means connected to a gas outlet port for providing a gas outlet under-pressure or sucking of gas in response to a control signal. Learn More

A U.S. Patent for a "Process for the Purification of a Growth Factor Protein" was awarded to Octapharma on February 26th, 2019. The present invention is a method of purifying a Growth Factor Protein in a purification sequence employing chromatography is provided. The method comprises performing at least one chromatography step using a multimodal resin, binding the Growth Factor Protein to said resin at a pH from 4 to 6.2, and eluting the Growth Factor Protein at a pH in the range of from 5.5 to 6.5. The elution of Growth Factor Protein is improved by addition of arginine and/or NaCl in the eluting buffer. Optionally the multimodal resin step is followed which results in a purity of the product greater than 90%. Learn More

A U.S. Patent for a "Distributed Perfusion Bioreactor System for Continuous Culture of Biological Cells" was awarded to the University of Massachusetts on February 26th, 2019. The present invention is a distributed bioreactor system in which a plurality of modular bioreactors are operated in parallel to produce and maintain a biological cell culture. A central or nurse perfusion bioreactor produces and maintains a cell culture and transfers portions of the cell culture to a plurality of modular peripheral perfusion bioreactors, each of which produces and maintains the cell culture in turn. In order to prevent contamination and facilitate segregation of particular peripheral bioreactors... Learn More

A U.S. Patent Application for a "Method for Chromatography Reuse" was published by Genentech on February 21st, 2019. The present invention provides methods for cleaning or regenerating a chromatography material for reuse. The methods of the invention can be used for cleaning or regenerating chromatography columns for reuse in the large-scale manufacture of multiple polypeptide products. Learn More

A U.S. Patent for "Pre-Sterilized Syringe System and Method of Use" was awarded to Paw Bioscience on February 19th, 2019. The present invention is a pre-sterilized fluid sampling syringe is provided which includes a locking vacuum syringe, 3-way valve, check valve and thermoplastic inlet tubing capable of both aseptic welding and direct connections. The syringe is assembled with components and rendered sterile in its packaging. The packaging permits manipulation of the syringe by the user such that at time of use a vacuum can be generated in the syringe barrel by pulling and locking the plunger into a fully withdrawn position. Learn More

A U.S. Patent Application for "Variant RNAi" was published by Genzyme on January 25th, 2018. The present invention are RNAi molecules including a first strand containing a guide sequence and a second strand comprising a non-guide sequence where the non-guide sequence contains a bulge opposite the seed region of the guide sequences; e.g., opposite the cleavage sequence. In some aspects, the invention provides RNAi for treating Huntington's disease. Further provided herein are expression cassettes, vectors (e.g., rAAV, recombinant adenoviral, recombinant lentiviral, and recombinant HSV vectors), cells, viral particles, and pharmaceutical compositions containing the RNAi. Yet further provided herein are methods and kits related to the use of the RNAi, for example, to treat Huntington's disease.
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Original Publication Date: 01/25/18

A U.S. Patent for "Cryopreservation Bags and Method of Use Thereof for Closed System, High Capacity Cell Banking" was awarded to Merial on January 30th, 2018. The present invention provides a cell freezing and storage bag assembly and a method for using the assembly in banking eukaryotic cells for later seed train expansion. The bag is constructed principally of fluorinated ethylene propylene (FEP) fabric, and is designed to be filled such that the cell suspension has a very thin cross-section. The bag design includes at least an inlet conduit and an outlet or inoculation conduit, which can be sterilely welded to the source of the eukaryotic cells. The use of at least two sterile-weldable conduits allows for "closed system" filling of the bags, which significantly reduces the risk of contamination relative to other cell-banking methods. The bag also include a sleeve, which can be thermo-welded to form an enclosure, which protects the inlet and outlet conduits against contamination and mechanical damage during freezing, storage and subsequent thawing. In the method, once each bag is filled, its corresponding inlet conduit is sealed, and both the inlet and outlet conduits are enclosed within the bag's sleeve. This closed system method obviates the need for sterile environments (e.g. laminar flow unit).
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Original Publication Date: 01/30/18

A U.S. Patent for "Aseptic Coupling Devices" was awarded to Colder on January 30th, 2018. The present invention is  an aseptic coupling device, comprising: a member defining aseptic fluid passage therethrough; a seal member coupled to a front surface of the member; a membrane coupled to the front surface of the member and positioned to cover the seal member; and a cap releasably coupled to the member, the cap including a bottom member positioned to engage a lower portion of the membrane, the bottom member extending in an axial direction relative to the member, the bottom member defining a surface that holds the lower portion of the membrane in the axial direction; wherein at least a portion of the cap is concave to surround the front surface of the member.
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Original Publication Date: 01/30/18

A U.S. Patent for a "Mechanical Agitator with Seal Housing Assembly" was awarded to Pall on January 30th, 2018. The present invention is a mechanically driven agitator for use in bioprocessing comprising (a) a rotatable shaft comprising a cylindrical element having a first end and a second end, the shaft having a vertical rotational axis; (b) an impeller comprising a hub mounted on the first end of the rotatable shaft, the hub having a horizontal axis perpendicular to the vertical rotational axis of the shaft, and at least two arms extending from the hub; (c) a seal housing assembly comprising an upper housing portion, and a lower housing portion.
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Original Publication Date: 01/30/18

A U.S. Patent Application for "Novel CHO Integration Sites  and Uses Thereof" was awarded to Regeneron on February 1st, 2018. The present invention is expression-enhancing nucleotide sequences for eukaryotic expressions systems are provided that allow for enhanced and stable expression of recombinant proteins in eukaryotic cells. Genomic integration sites providing enhanced expression and methods of use thereof are provided for expression of a gene of interest in a eukaryotic cell. Chromosomal loci, sequences, and vectors are provided for enhanced and stable expression of genes in eukaryotic cells.
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Original Publication Date: 02/01/18

A U.S. Patent Application for "ICOS Binding Proteins"  was awarded to GSK on February 1st, 2018. The present invention relates to an ICOS binding protein or antigen binding portion thereof that is an agonist to human ICOS and does not induce complement, ADCC, or CDC when placed in contact with a T cell in vivo and methods of treating cancer, infectious disease and/or sepsis with said ICOS binding protein or antigen binding portion thereof. Further the ICOS binding proteins or antigen binding portions thereof of the present invention are capable of activating a T cell when placed in contact with said T cell; stimulating T cell proliferation when placed in contact with said T cell and/or inducing cytokine production when placed in contact with said T cell.
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Original Publication Date: 02/01/18

A U.S. Patent Application for a "Pharmaceutical Formulation" was awarded to UCB on February 1st, 2018.  The present invention addresses the identified need for stable long term storage of antibodies by providing a novel liquid formulation comprising a therapeutic protein as active ingredient, particularly an antibody. A differential stabilizing effect has now been surprisingly observed between stabilizers with respect to the appearance of soluble aggregates as compared to large insoluble aggregates (precipitates) in a liquid pharmaceutical formulation. This surprising finding has led to a new pharmaceutical formulation exhibiting reduced protein aggregation and precipitation after long term storage. In a more specific manner the invention further provides a liquid formulation comprising an antibody binding specifically to CSF1R as an active ingredient.
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Original Publication Date: 02/01/18

A U.S. Patent Application for "Method and Systems for Providing Buffer Solutions Formulation" was awarded to Lonza on February 8th, 2018. The present invention is  a method for delivering a processing solution includes providing a concentrated processing solution in a bioprocess container, the concentrated processing solution being produced at a first site. The method also includes combining the concentrated processing solution with a biopolymer containing solution produced in a bioreactor at a second site different from the first site. In some embodiments, the processing solution is a buffer for processing products of cells cultured in a bioreactor. A system and a pharmaceutical production facility for carrying out the method is also provided.
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Original Publication Date: 02/08/18

A U.S. Patent Application for an "Endogenous Auto-Fluorescent Biological Markers for Assessing a Biological Parameter of a Cell" was awarded to Lonza on February 8th, 2018. The present invention is a method of determining if the value of a biological parameter of a cell culture in a liquid changes as a function of time, said method comprising: (a) irradiating the cell culture or a sample thereof with a light source emitting a specific excitation wavelength to generate a fluorescent signal from an endogenous auto-fluorescent biological marker; (b) quantifying, at a specific emission wavelength, the fluorescent signal associated with the endogenous auto-fluorescent biological marker to obtain a fluorescent value; (c) determining if the fluorescent value of step (b) changes as a function of time in the cell culture; and (d) determining the biological parameter of the cell culture based on the fluorescent value in real time, wherein a modulation in the fluorescent value indicates a modulation in the value of the biological parameter characterizing the value of the biological parameter (i) as changing as a function of time when the fluorescent value is determined...
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Original Publication Date: 02/08/18

A U.S. Patent Application for "Methods for Controlling Protease Production" was awarded to Real Oy on February 8th, 2018. The present invention is related to the field of protein production. It introduces novel host cells with low protease activity, a novel protease regulator, its use in expression systems and protein production, and a method of producing host cells for protein production. As a matter of practice microorganisms, such as fungi and filamentous fungi, are widely used as host cells for expression and extracellular secretion of proteins of interest, such as recombinant proteins. One disadvantage frequently encountered with microorganisms, when used as host cells, is their inherent production and secretion of proteolytic enzymes that degrade the protein of interest. This problem is particularly difficult when producing proteins of interest that are sensitive, unstable, or both. Thus, endogenous proteases of the host cell at least reduce the yield of the protein of interest and may even prevent its production.
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Original Publication Date: 02/08/18

A U.S. Patent for "Removal of Microorganisms from Fluid Samples Using Nanofiber Filtration Media" was awarded to EMD Millipore February 13th, 2018. The present invention is a method for removing microorganisms from liquid samples and a nanofiber containing liquid filtration medium that simultaneously exhibits high liquid permeability and high microorganism retention. Microorganisms such as bacteria, particularly B. Diminuta, are removed from a liquid by passing the liquid through a porous nanofiber containing filtration medium having a B. Diminuta LRV greater than about 9, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. Another method for removing microorganisms such as bacteria and Mycloplasma, includes passing the liquid through a porous nanofiber containing filtration medium having a microorganism LRV greater than about 8, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. The filtration medium can be in the form of a fibrous electro spun polymeric nanofiber liquid filtration medium mat.
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Original Publication Date: 02/13/18

A U.S. Patent for "Wireless Enabled Bags and Containers" was awarded to EMD Millipore on February 13th, 2018. The present invention provides a process for incorporating a wireless device into a plastic container as part of the steps of manufacturing the container. The plastic container can be a flexible plastic bag and are formed of one or more sheets, generally two or more sheets of plastic film or a rigid plastic container such as a tub or tote. The bags are formed by sealing together adjacent edge portions of each film layer. One embodiment of the present invention is to incorporate a wireless device between the edge portions of the film(s) before or during sealing so that the wireless device becomes permanently sealed into the film material but is isolated from both the bag interior and the outside environment. Another embodiment is to incorporate the wireless device onto or into a plastic component that is sealed to the container, such as a nipple or port, so that the wireless device becomes permanently sealed to the container but is isolated from both the container interior and the outside environment.
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Original Publication Date: 02/13/18

A U.S. Patent for a "Disposable Bioreactor System" was published by Finesse on January 16th, 2018. The present invention is an apparatus comprising: (a) a hollow toroidal one-piece polymeric bioreactor vessel comprising at least one port configured to receive at least one pre-inserted and pre-calibrated sensor to monitor a bioprocess carried out in said hollow toroidal one-piece polymeric bioreactor vessel; and (b) a drive configured to move the hollow toroidal one-piece polymeric bioreactor vessel such that there is build-up of a resonant frequency traveling wave of fluid orbiting in one direction in an interior of the hollow toroidal one-piece polymeric vessel when a particular amplitude and orbital speed is imparted to said hollow toroidal one-piece polymeric bioreactor vessel, wherein the resonant frequency depends on the size and shape of the hollow toroidal one-piece polymeric bioreactor vessel, and wherein at least a portion of an inner surface of said hollow toroidal one-piece polymeric bioreactor vessel is textured with a plurality of upstanding protuberances and said hollow toroidal one-piece polymeric bioreactor vessel includes at least one exit port for the removal of gaseous by-products.
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Original Publication Date: 01/16/18

A U.S. Patent for a "Buffer System for Protein Purification" was published by GSK on January 16th, 2018. The present invention is a method for purifying a protein from a contaminated solution thereof comprising the steps of: (1) passing the protein through a series of chromatography steps operated in a mode chosen from: bind-elute mode and flow-through mode, using a sodium chloride-free multi-component buffer system, wherein the chromatography steps comprise affinity chromatography and at least one additional chromatography step chosen from: anion exchange chromatography, cation exchange chromatography, and mixed-mode chromatography, and wherein the sodium chloride-free multi-component buffer system comprises: (a) an organic acid, (b) at least one component chosen from an alkaline metal and an ammonium salt of the conjugate base of the organic acid of (a), and (c) an organic base; and wherein the sodium chloride-free multi-component buffer system is used throughout the series of chromatography steps; and (2) recovering the purified protein.
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Original Publication Date: 01/16/18

A U.S. Patent for "Protein Purification" was awarded to Genentech on January 16th, 2018. The present invention is a method for purifying a polypeptide from a composition comprising the polypeptide and a contaminant, which method comprises the following steps performed sequentially: (a) loading the composition onto an ion exchange material; (b) washing the ion exchange material with wash buffer using a multi-slope gradient, wherein the multi-slope gradient comprises two or more segments of linear salt gradients with different slopes wherein the slope is greater in the first segment than in any additional segments, the increase in the salt concentration of the wash buffer is greater in the first segment of the multi-slope gradient wash than in subsequent segments, and each segment of the multi-slope wash ends when a predetermined polypeptide concentration is measured in the flowthrough, wherein each segment of the multi-slope gradient has a progressively shallower slope; and (c) eluting the polypeptide from the ion exchange material.
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Original Publication Date: 01/16/18

A U.S. Patent for a "pH Sensor for Single Use Equipment" was awarded to Emerson on January 16th, 2018. The present invention is a single use pH sensor housing for a single use container is provided. The single use pH sensor housing includes a compartment configured to house a single use pH sensor. In one embodiment, the single use pH sensor housing comprises an actuator configured, when actuated, to transition the single use pH sensor from a storage position to a deployed position. In the storage position, the pH sensor is in fluidic contact with a buffer solution. In the deployed position, the single use pH sensor is in fluidic contact with an interior of the single use container. During the transition from the storage position to the deployed position, the buffer solution moves from a sensor portion of the compartment to a storage portion of the compartment such that the buffer solution is isolated from contact with the interior of the single use container.
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Original Publication Date: 01/16/18

A U.S. Patent for "Microorganism Growth and Products Recovery" was awarded to HRD on January 23rd, 2018.  The present invention is a method of generating products from microorganisms, comprising super-saturating a liquid medium with a gas consumable by the microorganisms in a high shear device operating at a shear rate of greater than 1,000,000 s-1 to produce a gas-super-saturated (GSS) medium, wherein the GSS medium maintains a GSS level for at least 10 minutes; feeding the GSS medium to microorganisms; allowing the microorganisms to grow by consuming the gas and generate products via photosynthesis or chemosynthesis; and recovering the products. In an embodiment, the microorganisms are genetically modified. In an embodiment, the microorganisms include bacteria, protozoa, algae, or fungi, or a combination thereof. In an embodiment, the gas consumable by the microorganisms is selected from the group consisting of carbon dioxide, nitrogen, air, oxygen, methane, and combinations thereof.
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Original Publication Date: 01/23/18

A U.S. Patent for "Capture and Elution of Bio-Analytes via Beads that are Used to Disrupt Specimens" was awarded to Claremont Biosolutions on January 23rd, 2018. The present invention is a device to lyse cell specimens which include cells containing a biological material including at least one of nucleic acids or proteins or polypeptides, the device comprising: an outer vessel that forms an outer chamber therein having a circular cross-section with an inner diameter D1, the outer vessel having at least two outer vessel ports to provide respective fluid communicative paths between the outer chamber and an exterior of the outer vessel; an inner vessel that forms an inner chamber therein, the inner vessel having a circular cross-section with an outer diameter D2 sized to be closely and pivotably received in the outer chamber of the outer vessel with a fluid tight seal there between.
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Original Publication Date: 01/23/18

A U.S. Patent Application for "Bag Assembly Sterilizable by Gamma Irradiation" was published by Entegris on January 25th, 2018. The present invention is a bag assembly capable of withstanding sterilization by gamma irradiation, the bag assembly including: a bag portion having first and second walls, wherein each of the first and second walls comprise at least one sheet of a fluoropolymer film; and a fitment including first and second sidewalls extending between opposing end points, wherein a portion of each of the first and second walls of the bag portion are attached to each other along at least a portion of a perimeter of the bag assembly up to the opposing end points of the fitment defining an interior of the bag portion, and wherein each of the first and second walls are bonded individually to one of the first and second sidewalls of the fitment, and at least one fitting extending from the fitment, wherein the at least one fitting is in communication through the fitment to the interior of the bag portion.
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Original Publication Date: 01/25/18

A U.S. Patent for "Single-Pass Filtration Systems and Processes" was awarded to MilliporeSigma on February 19th, 2019. The present invention provides, in various embodiments, hybrid single-pass tangential flow filtration assemblies, disposable single-pass tangential flow filtration solutions, scalable single-pass tangential flow filtration assemblies, and adaptable modular single-pass tangential flow filtration solutions. In other embodiments, the invention relates to processes for recovering proteins from the surface of a filtration membrane in a single-pass tangential flow filtration assembly and for cleaning a tangential flow filtration assembly. Learn More

A U.S. Patent Application for a "Method for Stabilizing Proteins" was published by Lonza on December 14th, 2017. The present invention is a method of producing a stabilized product, e.g., a stabilized protein, expressed in a recombinant host cell, comprising: maintaining a redox potential difference in the range of -50 mV to -300 mV from a non-stabilized product to a stabilized product during separation of cells from production culture and collection of a supernatant, wherein separation of cells from a production culture and collection of supernatant is conducted without sparging or sufficiently little sparging that the sparging does not substantially alter the redox potential in the production culture and the supernatant, thereby producing a stabilized product, e.g., an isolated, stabilized protein.
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Original Publication Date: 12/14/17

A U.S. Patent for "Variants of C-type Natriuretic Peptide" was awarded to BioMarin on February 13th, 2018.  The present invention provides variants of C-type natriuretic peptide (CNP), pharmaceutical compositions comprising CNP variants, and methods of making CNP variants. The CNP variants are useful as therapeutic agents for the treatment of diseases responsive to CNP, including but not limited to bone-related disorders, such as skeletal dysplasias (e.g., achondroplasia), and vascular smooth muscle disorders (e.g., restenosis and arteriosclerosis).
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Original Publication Date: 02/13/18

A U.S. Patent for "Antibody Purification by Cation Exchange Chromatography" was awarded to Genentech on February 20th, 2018. The present invention is a method for purifying rituximab from a composition comprising the rituximab and one or more contaminants selected from the group consisting of Chinese Hamster Ovary Proteins (CHOP), leached protein A, DNA, and aggregated rituximab, which method comprises the sequential steps of: (a) loading the composition onto a cation exchange material wherein the composition is at a pH from about 4.0 to about 6.0; (b) washing the cation exchange material with a first wash buffer at a pH from about 6.8 to about 9.0 and a conductivity of 0.1 to 3 mS/cm; (c) washing the cation exchange material with a second wash buffer at a pH from about 5.0 to about 6.0; and (d) eluting the rituximab from the cation exchange material using an elution buffer with a pH from about 5.0 to about 6.0 and a conductivity from about 10 mS/cm to about 100 mS/cm.
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Original Publication Date: 02/20/18

A U.S. Patent for "Single-Use Biopharmaceutical Device for Producing, Storing, and Transporting a Biopharmaceutical Material, and Corresponding Multilayer Tube" was awarded to Sartorius Stedim on February 20th, 2018. The present invention is a device including: a bag, a tube section having a wall defining a free longitudinal space, and a plastic connector, which are all fused together, the wall including a contact layer made of a material other than PVC, selected from PE, EVA, PP, ETFE, and PVDF, and a functional layer including at least one basic functional layer of a material selected for the function thereof (flexibility, sturdiness, handling, opacity or transparence, gas barrier) and selected from the family including PE, PET, a PA, EVA, EVOH, SEBS, PETG, and PVDF, a bag, another tube section, and/or a connector fused to the biopharmaceutical tube and including a contact layer made of a material capable of being in contact with the biopharmaceutical material, which is capable of being fused onto itself, and which is identical or similar to the material of the contact layer of the biopharmaceutical tube.
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Original Publication Date: 02/20/18

A U.S. Patent Application for "Methods of Processing a Fluid Including a Recombinant Therapeutic Protein and Use  Thereof" was published by Genzyme on February 22nd, 2018. The present invention is a method of processing a fluid comprising a recombinant therapeutic protein, the method comprising: (a) providing a circuit system comprising (i) a tangential flow filtration (TFF) unit having first and second inlets, and (ii) a conduit in fluid communication between the first and second inlets, comprising at least one port for flowing fluid into or out of, or both, of the system, wherein the system is configured such that fluid can be flowed through the conduit and the TFF unit, and filtrate not comprising the recombinant therapeutic protein can be collected from the TFF unit...
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Original Publication Date: 02/22/18

A U.S. Patent Application for a "Method of Producing a Polypeptide or Virus of Interest in a Continuous Cell Culture" was published by Baxalta on February 22nd, 2018. The present invention is a chemostat-like continuous cell culture system that combines certain advantages of perfusion open systems and chemostat open systems to improve the culturing of mammalian cells, e.g., genetically modified cells, particularly in serum-free or chemically-defined media. The continuous culture system described herein involves culturing mammalian cells in a continuous cell culture system, which comprises a cell retention device, wherein the cell culture system has a dilution rate (D) of less than about 2 d.sup.-1, and a cell density of less than about 2.times.10.sup.7 cell/mL. Also described herein is a method for producing a polypeptide and/or virus of interest in a continuous cell culture, the method comprising culturing mammalian cells expressing the polypeptide and/or virus of interest in a continuous cell culture system, which comprises a cell retention device, wherein the cell culture system has a dilution rate (D) of less than about 2 d.sup.-1, and a cell density of less than about 2.times.10.sup.7 cell/mL; and recovering the polypeptide and/or virus of interest from medium of the cell culture system.
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Original Publication Date: 02/22/18

A U.S. Patent Application for a "Method for Purifying Viral Vectors" was published by GSK on February 22nd, 2018. The present invention relates to methods of purifying viral vectors from cell culture. In particular, the invention relates to a method of purifying a supernatant containing viral vectors from a cell culture, comprising removing cells by filtering said cell culture using diatomaceous earth. Furthermore, the present inventors have found that there is an optimum amount of diatomaceous earth to use when purifying viral vectors. Interestingly, using the recommended maximum amount of diatomaceous earth caused a decrease in percentage recovery of viral vector. Reducing the amount of diatomaceous earth has the added advantage of reducing the cost of goods when purifying viral vectors.
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Original Publication Date: 02/22/18

A U.S. Patent for a "Biomanufacturing Suite and Methods for Large-Scale Production of Cells, Viruses, and Biomolecules" was awarded to Biovest/Cell Culture Company on February 27th, 2018. The present invention is a method for large-scale production of cells and/or cell-derived products, comprising: providing one or more production modules, wherein each of the one or more production modules comprises: (a) a cultureware module comprising a plurality of hollow-fiber bioreactors, an intracapillary reservoir, an extracapillary reservoir, and an interface plate with said plurality of hollow-fiber bioreactors mounted thereto, wherein each hollow-fiber bioreactor has an intracapillary space and an extracapillary space, and wherein each hollow-fiber bioreactor is connected to an adjacent hollow-fiber bioreactor by a flow path...
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Original Publication Date: 02/27/18

A U.S. Patent for "Sterile Connection/Disconnection  Coupling and Method" was awarded to Millipore Sigma on February 27th, 2018. The present invention is a  fluid transfer device and method that allows for sterile wet connections, allows the connection to be reversed, and allows the connection to be reconnected, while leaving the connectors sterile and reusable under pressure. In certain embodiments, the device includes a first member and a second member, the latter adapted to receive the former in locking engagement upon actuation of the device to create fluid communication between the two in a sterile manner. Each of the members include a door that when opened, allows the first member to be linearly displaced into the second member to allow fluid to be transferred. When fluid transfer is complete, the first member can be retracted from the second member, and the doors closed.
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Original Publication Date: 02/27/18

A U.S. Patent Application for a "Bioreactor with Multiple Coupled Vessels" was published by Finesse on March 1st, 2018. The present invention is a bioreactor system that may include (a) two or more fluidically coupled vessels configured to collectively carry out a bioreaction; (b) one or more fluidic paths coupling the two or more vessels to one another, where the fluidic paths are configured to provide flow of culture medium between the two or more vessels; (c) one or more fluid transfer devices along at least some of the one or more fluidic paths; and (d) a control system. The control system may be configured to (i) read or receive values of one or more parameters characterizing the culture medium in one or more of the vessels, and (ii) use the values to determine an adjusted flow rate in at least one of the fluidic paths to maintain substantially uniform values of the one or more parameters in the culture medium from vessel-to-vessel among the two or more vessels.
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Original Publication Date: 03/01/18

A U.S. Patent Application for a "Bioreactor with Multiple Coupled Vessels" was published by Finesse on March 1st, 2018. The present invention is a bioreactor system that may include (a) two or more fluidically coupled vessels configured to collectively carry out a bioreaction; (b) one or more fluidic paths coupling the two or more vessels to one another, where the fluidic paths are configured to provide flow of culture medium between the two or more vessels; (c) one or more fluid transfer devices along at least some of the one or more fluidic paths; and (d) a control system. The control system may be configured to (i) read or receive values of one or more parameters characterizing the culture medium in one or more of the vessels, and (ii) use the values to determine an adjusted flow rate in at least one of the fluidic paths to maintain substantially uniform values of the one or more parameters in the culture medium from vessel-to-vessel among the two or more vessels.
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Original Publication Date: 03/01/18

A U.S. Patent Application for "Methods and Kits for Cell Activation" was published by GE on March 1st, 2018. The present invention provides methods and kits for activating T cells, the method comprising providing a population of T cells, adding a plurality of first agents, where the first agent comprises a T-cell activator and a first binder moiety, and adding a second agent comprising a plurality of capture oligomers, where at least a segment of at least one of the plurality of capture oligomers is capable of associating with the first binder moiety. The method further comprises incubating the population of T cells, whereby at least a portion of the population of T cells is activated.
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Original Publication Date: 03/01/18

A U.S. Patent for "Recombinant Cell Clones Having Increased Stability and Methods of Making and Using the Same" was awarded to Baxalta on March 6th, 2018. The present invention discloses stable recombinant cell clones which are stable in serum- and protein-free medium for at least 40 generations, a biomass obtained by multiplying the stable cell clone under serum- and protein-free culturing conditions, and a method of preparing recombinant proteins by means of the biomass. Furthermore, the invention relates to a method of recovering stable recombinant cell clones.
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Original Publication Date: 03/06/18

A U.S. Patent for "Method of Determining Virus Removal from a Sample Containing a Target Protein Using Activated Carbon" was awarded to Millipore Sigma on March 6th, 2018. The present invention is a method for determining whether activated carbon can be used for the removal of viruses from a sample containing a target protein having a protein concentration equal to or greater than 0.2 g/L, the method comprising the steps of: (a) providing a portion of a sample comprising a target protein having a protein concentration equal to or greater than 0.2 g/L: (b) adding a virus to the portion of the sample in the amount ranging from 10.sup.4 to 10.sup.9 PFU/mL...
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Original Publication Date: 03/08/18

A U.S. Patent for "Methods of Perfusion Culturing Using a Shake Flask and Microcarriers" was awarded to Genzyme on March 6th, 2018. The present invention is a method of culturing an adherent mammalian cell, the method comprising: providing a shake flask containing an adherent mammalian cell disposed in a first liquid culture medium, wherein the first liquid culture medium occupies about 20% to about 30% of the volume of the shake flask and contains a plurality of microcarriers at a concentration of about 1.0 g/L to about 15.0 g/L; incubating the shake flask for a period of time at about 32.degree. C. to about 39.degree. C. and with a rotary agitation of about 85 revolutions per minute (RPM) to about 125 RPM...
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Original Publication Date: 03/06/18

A U.S. Patent for a "Flow Measurement System for Single-Use Containers" was awarded to Emerson on March 6th, 2018. The present invention is a venturi flowmeter for connection to single-use containers is provided. The venturi flowmeter includes a meter body formed of a polymer and configured to allow fluid flow therethrough. A first annular diaphragm is mounted proximate an inner surface of the meter body has a first internal diameter. A second annular diaphragm is mounted proximate an inner surface of the meter body has a second internal diameter different from the first internal diameter.
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Original Publication Date: 3/06/18

A U.S. Patent for a "Reactor Foam Sensor Systems and Methods of Use" was awarded to Life Technologies on March 28th, 2017. The present invention is a foam sensor system comprising: a flexible bag comprised of a polymeric material and bounding a compartment; a foam sensor assembly mounted on the flexible bag and comprising: a base being secured to the flexible bag; a foam contact being spaced apart from the base and disposed within the compartment of the flexible bag, the foam contact being comprised of a metal with at least a portion of the foam contact having a first diameter; and a transition member comprised of a metal and extending between the base and the foam contact with at least a portion of the transition member being exposed within the compartment of the flexible bag, at least a portion of the transition member having a second diameter that is equal to or less than 1/3 of the size of the first diameter, the foam contact and transition member being connected together so that an electrical signal can pass therethrough; and a ground assembly mounted on the flexible bag and comprising a ground contact disposed within the compartment of the flexible bag and being comprised of a metal, the foam sensor assembly and the ground assembly being configured so that an electrical potential can be applied between the foam contact and the ground contact.
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Original Publication Date: 3/28/2017

A U.S. Patent for the "Quantification of Misfolded TNFR2:Fc" was awarded to Sandoz on March 21st, 2017. The present invention is a method for determining a relative amount of Cys.sub.78-Cys.sub.88 disulfide bridged TNFR2:Fc in a sample comprising Cys.sub.74-Cys.sub.88/Cys.sub.78-Cys.sub.96 disulfide bridged TNFR2:Fc and Cys.sub.78-Cys.sub.88 disulfide bridged TNFR2:Fc, wherein the method comprises the steps of: (a) providing a sample comprising a mixture of Cys.sub.78-Cys.sub.88 disulfide bridged TNFR2:Fc and Cys.sub.74-Cys.sub.88/Cys.sub.78-Cys.sub.96 disulfide bridged TNFR2:Fc; (b) denaturing and alkylating the sample of step (a); (c) subjecting the sample resulting from step (b) to tryptic digestion under non-reducing conditions; (d) determining by HPLC the amount of a fragment indicative of Cys.sub.78-Cys.sub.88 disulfide bridged TNFR2:Fc in the sample resulting from step (c); and (e) determining the relative amount of the Cys.sub.78-Cys.sub.88 disulfide bridged TNFR2:Fc in the sample based on the amount of the fragment indicative of Cys.sub.78-Cys.sub.88 disulfide bridged TNFR2:Fc relative to the amount of a fragment not affected by disulfide bridging of Cys.sub.74, Cys.sub.78, Cys.sub.88 and Cys.sub.96; wherein the amino acid sequence of the TNFR2 part of TNFR2:Fc has at least 97% identity to the amino acids 1-235 of the amino acid sequence of SEQ ID NO: 1, and wherein the fragment indicative of Cys.sub.78-Cys.sub.88 disulfide bridged TNFR2:Fc consists of SEQ ID NO:4 ("T7").
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Original Publication Date: 3/21/2017

A U.S. Patent for the "Use of Metal Ions for Modulation of Protein Glycosylation Profiles of Recombinant Proteins" was awarded to AbbVie on March 21st, 2017. Protein glycosylation greatly influences the structure, function, and pharmacokinetics of recombinant proteins. Here, growth media supplemented with metal ions is shown to modulate the protein glycosylation profile of recombinant proteins expressed in a variety of eukaryotic cell lines. In particular, millimolar amounts of ferric salts (e.g. ferric nitrate, ferric citrate, etc.) significantly increased the percentage of galactosylated N-glycan species. The effect on protein glycosylation was concentration-dependent manner up to 1.0 mM across multiple cell lines without adverse effects on cell viability. The use of iron supplements in cell culture media provides an efficient and effective approach towards the specific re-targeting of N-glycan glycoform profiles of recombinantly expressed proteins.
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Original Publication Date: 3/21/2017

A U.S. Patent for "Antibody and Protein Formulations" was awarded to Bayer on March 14th, 2017. The present invention provides liquid and lyophilized antibody and protein-based formulations that are substantially isotonic and low viscosity and that contain substantially no inorganic salt. The antibody and other protein formulations presented herein contain from about 0 mM to about 30 mM histidine; from about 50 ppm to about 200 ppm of a non-ionic surfactant such as, for example, polysorbate (Tween.RTM.) 80 or polysorbate (Tween.RTM.) 20; from about 88 mM to about 292 mM of a sugar or sugar alcohol such as, for example, mannitol, dextrose, glucose, trehalose, and/or sucrose; from about 0 mM to about 50 mM arginine; from about 0 mM to about 50 mM lysine; from about 0 mM to about 133 mM glycine or alanine; from about 0 mM to about 10 mM methionine; and from about 1 mg/ml to about 150 mg/ml of a protein at a pH from about pH 4.0 to about pH 6.0.
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Original Publication Date: 3/14/2017

A U.S. Patent for a "Bacterial Host Strain Comprising a Mutant SPR Gene and Having Reduced TSP Activity" was awarded to UCB Pharma on March 7th, 2017. The present invention provides a recombinant gram-negative bacterial cell comprising: a mutant spr gene that encodes a mutant spr protein having a mutation that is an amino acid substitution at one or more amino acids selected from the group consisting of H145, H157, and C94, wherein the wild type spr protein has the sequence of SEQ ID NO: 21, and a mutation in the Tsp gene that encodes a mutated Tsp protein having reduced protease activity or a mutation in the Tsp gene or regulatory sequence of the Tsp gene that reduces or eliminates expression of the Tsp protein, wherein said mutant spr protein reduces lysis of cells containing the mutated Tsp gene. These new bacterial strains carrying alternative spr mutants provide advantageous means for producing recombinant proteins.
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Original Publication Date: 3/7/2017

A U.S. Patent for "Fluid Processing Systems and Methods" was awarded to Entegris on March 7th, 2017. The present invention are systems and methods for delivering fluid-containing feed materials to process equipment are disclosed. A liner-based pressure dispensing vessel is subjected to filling by application of vacuum between the liner and overpack. Multiple feed material flow controllers of different calibrated flow ranges may be selectively operated in parallel for a single feed material. Feed material blending and testing for scale-up may be performed with feed materials supplied by multiple liner-based pressure dispensing containers. A gravimetric system may be used to determine concentration of at least one component of a multi-component solution or mixture. In one aspect, the invention relates to a method including use of a collapsible liner disposed within an overpack container defining an interstitial space between the liner and container, the method comprising applying sub atmospheric pressure to the interstitial space to cause the liner to expand and draw the feed material from a feed material source into an interior volume of the liner. In another aspect, the invention relates to a feed material transport system comprising: (A) a plurality of first feed material flow controllers arranged in parallel and in fluid communication with a first feed material source; and (B) at least one flow consolidation element operatively arranged to selectively combine flows of the first feed material from the plurality of first feed material flow controllers when multiple flow controllers of the first flow controllers are operated simultaneously.
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Original Publication Date: 3/7/2017

A U.S. Patent for a "Method for Rapidly Screening Microbial Hosts to Identify Certain Strains with Improved Yield and/or Quality in the Expression of Heterologous Proteins" was awarded to Pfenex on February 28th, 2017. The present invention relates to a method of assembling an array and using the array to simultaneously screen at least 10 nonidentical expression systems for testing expression of at least one heterologous recombinant protein, said method comprising: placing Pseudomonad or E. coli host cell populations in separate addressable locations of the array; introducing at least one expression vector encoding the at least one heterologous recombinant protein into each host cell population in the array to produce each of the at least 10 nonidentical expression systems in the array, wherein the array of at least 10 nonidentical expression systems includes at least 5 different host cell populations and at least 2 different expression vectors, wherein at least 3 of said at least 5 different host cell populations are deficient in their expression of at least one host cell protease, wherein the at least 10 nonidentical test expression systems in the array each comprises a different combination of a) a Pseudomonad or E. coli host cell population, and b) at least one of the at least 2 different expression vectors encoding the at least one heterologous recombinant protein, and simultaneously screening the at least 10 nonidentical test expression systems on the array; wherein at least one expression system in the array of the at least 10 nonidentical test expression systems overexpresses the at least one heterologous recombinant protein.
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Original Publication Date: 2/28/2017

A U.S. Patent for "In Vivo Production of Proteins" was awarded to Moderna Therapeutics on February 21st, 2017. The present invention relates to a method of producing a polypeptide of interest in vivo comprising contacting a mammalian cell, tissue or organism with at least one isolated mRNA encoding the polypeptide of interest; wherein the polypeptide of interest is apolipoprotein A-I (APOA1), and wherein the isolated mRNA encoding the polypeptide of interest has at least 80% identity to SEQ ID NO: 212. It provides nucleic acid based compounds or polynucleotides which encode a polypeptide of interest (e.g., modified mRNA or mmRNA) and which have structural and/or chemical features that avoid one or more of the problems in the art, for example, features which are useful for optimizing formulation and delivery of nucleic acid-based therapeutics while retaining structural and functional integrity, overcoming the threshold of expression, improving expression rates, half life and/or protein concentrations, optimizing protein localization, and avoiding deleterious bio-responses such as the immune response and/or degradation pathways.
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Original Publication Date: 2/21/2017

A U.S. Patent for "Separation Method and Separation Matrix" was awarded to GE on February 21st, 2017. The present invention relates to separation of biomolecules, and more particularly to ion exchange separation of proteins. The invention also relates to a separation matrix suitable for separation of biomolecules and to a method of manufacturing such a matrix.  It involves a method of separating a biomolecule from at least one other component in a liquid, comprising a step of contacting said liquid with a separation matrix comprising a solid support and polymer chains bound to said solid support. The polymer chains comprise units derived from a first monomer of structure CH.sub.2.dbd.CH-L-X, where L is a covalent bond or an alkyl ether or hydroxysubstituted alkyl ether chain comprising 2-6 carbon atoms, and X is a sulfonate or phosphonate group. It esent invention relates to separation of biomolecules, and more particularly to ion exchange separation of proteins.
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Original Publication Date: 2/21/2017

A U.S. Patent for "Risk-Managed, Single-Use, Pre-Calibrated, Pre-Sterilized Sensors for use in Bio-Processing Applications" was awarded to Parker Hannifin on February 21st, 2017. The present invention is a single-use bio-solution processing sensor, comprising: a fluid conduit through which a biopharmaceutical solution flows during use of the sensor; an on-sensor memory device; a usage counter associated with the sensor; said usage counter includes a motion detector, the motion detector detects vibration corresponding to solution flow through the fluid conduit, and the memory device analyzes the vibration and designates the vibration as a counted sensor use event, whereupon the counted sensor use event is stored on the memory device and accumulates with prior or subsequent use events until a maximum use total stored on the memory device is attained; and the motion detector is an accelerometer that operates as a flow meter, whereby when a relatively non-compressible fluid flows through the fluid conduit a first accelerometer output is generated, and when a compressible fluid flows through the fluid conduit a second accelerometer output is generated, resulting in a differential between the first and second accelerometer outputs, thereby indicating an end to a cycle of a manifold within which the sensor is included.
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Original Publication Date: 2/21/2017

A U.S. Patent for "Systems and Methods for Status Indication in a Single-Use Biomedical and Bioprocess System" was awarded to GE on February 14th, 2017. The present invention is a disposable bioprocessing component comprising: a sensor comprising: a first portion attached at a predetermined position adjacent to the disposable bioprocessing component to detect a position and an operational state of the disposable bioproces sing component, and comprising a radio frequency identification (RFID) tag and configured to provide an identifier and a status indication based on the position and the operational state of the disposable bioprocessing component in real-time when activated; and a second portion separate from the first portion, and removably affixed to another component physically separated and spaced apart from the disposable bioprocessing component, and comprising a wireless sensor node and configured to: (i) supply power to and activate the first portion to transmit the status indication and the identifier, and (ii) provide network connectivity, only when the second portion is brought within a predetermined physical proximity of the first portion, wherein the identifier and status indication are transmitted for use by a control system for a bioprocessing platform to execute an action at the disposable bioprocessing component.
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Original Publication Date: 2/14/2017

A U.S. Patent for "Optical Sensors for Monitoring Biopharmaceutical Solutions in Single-Use Containers" was awarded to Parker on February 14th, 2017. The present invention is a disposable, pre-sterilized, and pre-calibrated, pre-validated sensor. The sensor comprises a disposable fluid conduit or bioreactor bag and a reusable sensor assembly. An optical bench or inset optical component or module is integrated within the disposable fluid conduit or bioreactor bag, which provides an optical light path through the conduit or bag. These sensors are designed to store sensor-specific information, such as calibration and production information, in a non-volatile memory chip on the disposable fluid conduit or bag and on the reusable sensor assembly. Methods for calibrating the sensor and for determining a target property of an unknown fluid are also disclosed. The devices, systems and methods relating to the sensor are suitable for and can be outfitted for turbidity sensing.
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Original Publication Date: 2/14/2017

A U.S. Patent for "Dielectric Spectroscopy Methods and Apparatus" was awarded to Bend Research on February 14th, 2017. The present invention is a method for determining a biological property of cells suspended in a liquid media, the method comprising: applying an electrical signal to said cells suspended in said liquid media at two or more signal frequencies to generate electrical property data; receiving biological property data obtained using an alternate analytical technique; generating at least one value representative of frequency dependence of said electrical property data; determining a first relationship between said biological property data and said electrical property data; determining a second relationship between (1) said value representative of the frequency dependence of said electrical property data and (2) a divergence between a magnitude of said biological property data and a magnitude of said electrical property data; determining a calibration function by combining said first relationship and said second relationship; by a computer, calculating said calibration function with subsequent electrical property data to determine said biological property of said cells; and adjusting one or more environmental conditions of said liquid media in response to determining said biological property of said cells.
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Original Publication Date: 2/14/2017

A U.S. Patent for a "Polymeric Remote Seal System for Single-Use Containers" was awarded to Emerson Process Management on February 7th, 2017. The present invention is a polymeric remote seal system for coupling a single-use container to a pressure measurement instrument. The polymeric remote seal system includes a process-side coupling, an instrument-side coupling and a fluidic coupling therebetween. The process-side coupling is configured to couple to the single-use container and is formed of a radiation sterilizable polymer. The process-side coupling has a process-side deflectable diaphragm that is configured to deflect in response to pressure within the single-use container. The instrument-side coupling is configured to couple to the pressure measurement instrument and is formed of a radiation sterilizable polymer. The instrument-side coupling is configured to fluidically convey fluid pressure to an isolation diaphragm of the pressure measurement instrument.
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Original Publication Date: 2/7/2017

A U.S. Patent for a "Purification of Fusion Proteins" was awarded to Merck on January 31st, 2017. The present invention relates generally to methods for purifying a Fc-fusion protein produced in a eukaryotic expression system. More specifically, the invention provides a robust and scalable downstream purification process suitable for use in manufacturing TNFR:Fc for human administration which comprises an optimized Protein A affinity chromatography step and two ion exchange chromatography steps both of which are operated in the bind-and-elute mode.
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Original Publication Date: 1/31/2017

A U.S. Patent for a "Flexible Bag for Cultivation of Cells" was awarded to GE on January 24th, 2017. The present invention is an inflatable bioreactor bag for cell cultivation comprising: a top sheet and a bottom sheet, each being formed of flexible material and joined together to form two end edges and two side edges; a plurality of tubular baffles, each tubular baffle being disposed within the inflatable bioreactor bag and mounted to the top sheet via a single inlet and outlet port corresponding to the tubular baffle for transporting material into and out of said inflatable bioreactor bag; and a plurality of diffusers mounted to the bottom sheet, each diffuser corresponding to each tubular baffle, and each diffuser is configured to mount each tubular baffle to the bottom sheet, wherein the tubular baffle extends in a direction away from the bottom sheet in a region where the shortest distance to the closest one of said two end edges is higher than about one fourth of the shortest distance between said two end edges, and wherein each diffuser comprising at least one opening forming an open flow-path for cell suspension through the diffuser and a lumen of the tubular baffle, wherein at least one baffle of the plurality of baffles is of a curved shape and in contact with the cell suspension within said inflatable bioreactor bag, and offset and spaced from the remaining of the plurality of the tubular baffles in the region.
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Original Publication Date: 1/24/2017

A U.S. Patent for a "Fluid Flow Cell Including a Spherical Lens" was awarded to MarqMetrix on February 19th, 2019. The present invention is a flow cell device including a spherical optical element is disclosed. The spherical lens can be sealed to the body of the flow cell device in a manner that provides external optical access to a fluid in an analysis region of a flow path through the flow cell device. The seal can be provided by an elastomer, a polymer, or a deformable metal. The disposition of the spherical lens to the flow path enables in situ optical analysis of the fluid. An optical analysis device can be removably connected to the flow cell device to provide the optical analysis. Learn More

A U.S. Patent for "Processing Biological Material for Flow Cytometry Evaluation for Virus Particles" was awarded to Virocyt on January 17th, 2017. The present invention is a method for processing biological materials for flow cytometry evaluation for virus particles, a mixture including biological material and purification particles is centrifuged to prepare a centrifuged composition including a supernatant that may be further processed prior to the flow cytometry evaluation. The purification particles include porous cores functionalized to capture smaller-size impurities in a biological material sample and a porous size-exclusion shell surrounding the core to exclude larger-size components of the biological material from entering into the core. Multiple samples may be processed in multi-sample processing units. A product may contain a sealed container with the unit quantity of purification particle in a storage liquid and a kit may include such a sealed container and a centrifugal filter.
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Original Publication Date: 1/17/2017

A U.S. Patent for a "Heat Transfer Baffle System and Uses Thereof" was awarded to ABEC on January 17th, 2017. The present invention is an improved heat transfer system for use in reaction vessels used in chemical and biological processes. Specifically, the method for controlling the temperature of a process being carried out in a reaction vessel, the method comprising: 1) providing a reaction vessel comprising at least one heat transfer baffle comprising: a. a first sub-assembly consisting essentially of a first material adjoined to a second material to form a first distribution channel, b. a second sub-assembly consisting essentially of a first material adjoined to a second material to form a second distribution channel, c. a closure bar that adjoins the first assembly and the second sub-assembly to one another; and d. a relief channel between the first sub-assembly and the second sub-assembly; wherein the closure bar sets the width of the relief channel, and the distribution channels and the relief channel do not communicate unless a leak forms within a distribution channel; and, 2) circulating heat transfer medium through the at least one heat transfer baffle.
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Original Publication Date: 1/17/2017

A U.S. Patent for an "Apparatus and Method for Automated Process Monitoring and Control with Near Infrared Spectroscopy" was awarded to ASL Analytical on January 10th, 2017. The present invention is a system and method for continuous, real-time process monitoring and control by means of near-infrared (NIR) spectroscopy provides analysis of static or flowing fluid streams which may range from clear to highly optically dense, including fluids primarily of aqueous composition. A NIR source passes through a wavelength selector to select one or more spectral segments, which are passed through the fluid stream at a fluid sampling interface and received at a sensor. A wavelength reference material is positioned in the optical path for calibration. Quantification of a plurality of characteristics or parameters of a fluid and suspended solids or cells contained therein may be performed. An all-solid-state implementation of the optical system ensures high robustness in laboratory and industrial settings.
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Original Publication Date: 1/10/2017

A U.S. Patent for "Stirred Tank Reactor Systems and Methods of Use" was awarded to Life Technologies on January 10th, 2017. The present invention is a method of mixing a fluid, the method comprising: positioning a flexible bag into a chamber of a support housing; delivering a fluid into a compartment of the flexible bag; and moving a mixing element within the compartment of the flexible bag so as to mix the fluid therein, the step of moving the mixing element comprising: removably inserting a drive shaft into a tubular connector having a first end and an opposing second end, the first end of the tubular connector being connected to the bag, the second end of the tubular connector being secured to an impeller disposed within the compartment of the flexible bag; and rotating the drive shaft so that the impeller rotates relative to the bag.
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Original Publication Date: 1/10/2017

A U.S. Patent for a "Disposable multivariable sensing devices having radio frequency based sensors" was awarded to GE on January 3rd, 2017. The present invention is a multivariable sensing device for sensing one or more parameters of a process fluid disposed in a container is provided. The multivariable sensing device includes a radio frequency based sensor configured to sense a physical parameter, a chemical parameter, a biological parameter, or combinations thereof, representative of the process fluid. The radio frequency based sensor includes a sensor substrate, a radio frequency coil disposed on at least a portion of the sensor substrate, and a support structure configured to be physically coupled to the container. Further, the support structure is configured to position the radio frequency based sensor in operative proximity to an inside of the container.
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Original Publication Date: 1/3/2017

A U.S. Patent for a "Methods of Perfusion Culturing Using a Shake Flask and Microcarriers" was awarded to Genzyme on March 6th, 2018. The present invention is based, at least in part, on the discovery that culturing a mammalian cell in the specific manner described herein results in a substantially improved viable cell density and recombinant protein production, and is able to effectively model (e.g., an accurate scale-down model) the recombinant protein production of a larger-scale continuous-perfusion bioreactor. Thus, the present specification includes methods of culturing a mammalian cell that include: providing a shake flask containing a mammalian cell disposed in a first liquid culture medium, where the first liquid culture medium occupies, e.g., about 20% to about 30% of the volume of the shake flask, and contains a plurality of microcarriers at a concentration of about 1.0 g/L to about 15.0 g/L; incubating the shake flask for a period of time at about 32° C. to about 39° C., e.g., about 32° C. to about 37° C., and with a rotary agitation of about 85 revolutions per minute (RPM) to about 125 RPM; and after about the first 48 to 96 hours of the period of time, continuously or periodically removing a first volume of the first liquid culture medium and adding to the first liquid culture medium a second volume of a second liquid culture medium, where the first and second volumes are about equal. Also provided are various methods that utilize these culturing methods.
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A U.S. Patent for a "Flow Measurement System for Single-Use Containers" was awarded to Rosemount on March 6th, 2018. A venturi flowmeter for connection to single-use containers is provided. The venturi flowmeter includes a meter body formed of a polymer and configured to allow fluid flow therethrough. A first annular diaphragm is mounted proximate an inner surface of the meter body has a first internal diameter. A second annular diaphragm is mounted proximate an inner surface of the meter body has a second internal diameter different from the first internal diameter.
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A U.S. Patent Application for "Dry Powder Cell Culture Products and Methods of Production Thereof" was published by Thermo Fisher on February 14th, 2019. The present invention provides powder nutritive medium, medium supplement and medium subgroup formulations, e.g., cell culture medium supplements (including powdered sera such as powdered fetal bovine serum (FBS)), medium subgroup formulations and cell culture media comprising all of the necessary nutritive factors that facilitate the in vitro cultivation of cells. The invention further provides powder buffer formulations that produce particular ionic and pH conditions upon reconstitution with a solvent. Learn More

A U.S. Patent Application for "Perfusion Bioreactor and Method for Using Same to Perform a Continuous Cell Culture" was published by Corning on February 14th, 2019. The present invention is a perfusion bioreactor comprising: a vessel having a housing comprised at least in part of gas permeable membrane, at least one opening and a cavity; at least one lid attachable to the vessel to cover the at least one opening; a porous membrane disposed within the cavity to divide the cavity into an inner compartment and an outer compartment; a fresh media port extending through the vessel or the at least one lid; a spent media port extending through the vessel or the at least one lid; and, a mixer. Learn More

A U.S. Patent for "Temperature Shift for High Yield Expression of Polypeptides in Yeast and Other Transformed Cells" was awarded to AlderBio Holdings on February 12th, 2019. The present invention is a method of producing a desired antibody in yeast cells, comprising: (a) culturing at a first temperature yeast cells comprising one or more genes that encode said desired antibody; and (b) culturing said yeast cells at a second temperature and allowing said yeast cells to produce said desired antibody; wherein said first temperature is between 27.5 degrees C. and 28.5 degrees C. and said second temperature is between 30 degrees C. and 31 degrees C. Learn More

A U.S. Patent Application for "Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase" was published by Genentech on February 7th, 2019. The present invention provides methods and compositions for reducing lactate production and increasing polypeptide production in cultured cells. In one aspect, the invention provides a method comprising culturing cells expressing a) a small interfering RNA (siRNA) specific for a lactate dehydrogenase (LDH) and b) an siRNA specific for a pyruvate dehydrogenase kinase (PDHK). Learn More

A U.S. Patent Application for "Method of Actuation of an Alternating Tangential Flow Diaphragm Pump" was published by Repligen on February 7th, 2019. The present invention is a control unit that includes a first connector configured to connect a proportional pressure regulator to a positive pressure supply and a second connector configured to connect the proportional pressure regulator to a negative pressure supply. The control unit further includes at least one sensor configured to detect an amount of air flow (volume per unit of time), positive or negative, within an air flow line connected to an output of the proportional pressure regulator, and a third connector configured to connect the air flow line to an air side of a diaphragm. Learn More

A U.S. Patent for "Methods and Devices Used for Redundant Sterile Filtration" was awarded to EMD Millipore on February 5th, 2019. The present invention is a redundant filtration system that includes at least one barrier filter as a process filter, the barrier filter having both hydrophilic and hydrophobic paths, allowing both fluid and gas permeability. The need for vents is eliminated, as is an intermediate drain filter. The device also can be dried in series. The filtration system includes a network of conduits and receptacles, the network receiving liquid raw and/or starting material at one end, conducting it through the process stream defined thereby, and producing the desired liquid product at another end. Learn More

A U.S. Patent for an "Apparatus and Method for Making a Sterile Connection of Flexible Tubing" was awarded to GE on February 5th, 2019. The present invention is an apparatus for substantially sterile connection of flexible tubing, including at least one tubing holder, which is adapted to receive one or more lengths of flexible tubing and which is also equipped with one or more sterilant applicators. The sterilant applicator is adapted to apply a sterilant to the length of tubing when the tubing length is received in the tubing holder. At least one cutter, which is movable in relation to the tubing holder and adapted to cut the length of tubing. Learn More

A U.S. Patent Application for a "Device and Method for Drawing a Liquid from a Process Tank" was published by Endress Hauser on January 31st, 2019. The present invention discloses a device for drawing a liquid from a process tank to be protected from contamination, including: a first receptacle for receiving the liquid withdrawn from the process tank; a first liquid line connecting the process tank with the first receptacle; and at least one first valve assembly disposed in the first liquid line and designed to block or release liquid transport through the first liquid line. The device includes at least one pressure sensor for detecting a pressure within the first receptacle. Learn More

A U.S. Patent for a "Semi-Automated Sampling System for Aseptic Sampling was awarded to GE on January 29th, 2019. The present invention is a semi-automated sampling assembly configured for aseptic sampling at one or more instances from a sample source having a biological inoculum is provided. The semi-automated sampling assembly includes a sampling conduit, a recovery conduit, one or more sampling kits, and a pumping device. The sampling conduit includes a first port and a second port, where the first port of the sampling conduit is configured to be operatively coupled to the sample source. Learn More

A U.S. Patent for a "Method of Culturing Eukaryotic Cells" was awarded to Genentech on January 29th, 2019. The present invention is a method for culturing Chinese hamster ovary (CHO) cells comprising: (i) providing cell culture inoculant comprising CHO cells in about 6 L of a bicarbonate-containing culture liquid to a vessel to achieve a target cell density of about 7.5.times.10.sup.5 CHO cells/mL, wherein said vessel has a volume of about 50 L and has walls that encapsulate said cell culture and a gas phase head space above said cell culture, and wherein said vessel comprises at least one port that provides an entrance and an egress of gas to and from said head space. Learn More

A U.S. Patent for an "Affinity Chromatography Matrix" was awarded to GE Healthcare on January 29th, 2019. The present invention discloses an immunoglobulin-binding protein comprising one or more mutated immunoglobulin-binding domains (monomers) of staphylococcal Protein A (E, D, A, B, C) or protein Z or a functional variant thereof, where in at least one of the one or more mutated monomers, the asparagine or histidine at the position corresponding to H18 of the B domain of Protein A or of Protein Z has been deleted or substituted with a first amino acid residue which is not proline or asparagine. Learn More

A U.S. Patent for "High Density Cell Banking Methods" was awarded to Genzyme on January 29th, 2019. The present invention is a non-centrifugal method for producing a high-density frozen mammalian cell bank, the method comprising: a) culturing mammalian cells in a perfusion bioreactor to a first cell density by continuously removing growth medium from a culture and replacing with fresh growth medium, wherein the bioreactor is coupled to a cell retention system comprising an alternating tangential flow filtration system
including a filter. Learn More

A U.S. Patent Application for "Production of Proteins in Glutamine-Free Cell Culture Media" was published by
Genentech on January 24th, 2019. The present invention is based, at least in part, on the unexpected finding that not only can recombinant proteins be produced in a mammalian host cell using a glutamine-free production medium without any significant adverse effect, in fact the use of a glutamine-free medium in the production phase significantly increases cell viability, culture longevity, specific productivity and/or the final recombinant protein titer. Learn More

A U.S. Patent for "Apparatus for Connection of Thermoplastic Tubing" was awarded to GE on January 22nd, 2019. The present invention discloses an apparatus for aligning and supporting a first and a second length of thermoplastic tubing, preparatory to and during cutting and welding of said lengths of tubing, that includes a first holder arranged to accommodate portions of the first and second lengths of tubing in a first and a second elongated holding space respectively, a second holder arranged to accommodate portions of the first and second lengths of tubing in a third and a fourth elongated holding space respectively, and movable... Learn More

A U.S. Patent for "Methods for Viral Inactivation and Other Adventitious Agents" was awarded to Genentech on January 22nd, 2019. The present invention is a method for inactivating virus or adventitious agents in a mammalian cell culture media while the media maintains suitability for mammalian cell culture, said method comprising a) adjusting the pH of the cell culture media, wherein the cell culture media has a pH 5.0 to pH 6.9 prior to HTST treatment, b) subjecting the cell culture media to HTST treatment, and c) raising the pH of the cell culture media to between 6.9 and 7.2 after HTST treatment. Learn More

A U.S. Patent for a "Virtual Transmitter for Bioreactor Automation System" was awarded to Finesse on January 22nd, 2019. The present invention relates to an environmental condition monitoring and control system employing a software-based virtual transmitter for a bioreactor or mixer. The system includes a probe for measuring a condition in a bioreactor that can generate a signal. Measured conditions may include pH, DO, temperature, and pressure. The signal can travel to an electronic card capable of converting the signal from analog to digital and the card can then send the converted signal to a digital controller. Learn More

A U.S. Patent Application for "Particle Sensor with Interferent Discrimination" was published by BugLab on January 17th, 2019. The present invention provides methods and devices to measure particle suspension concentrations in the presence of potential interferents. Particle back-scatter readings are taken at light wavelengths that are absorbed by the medium before interacting with surrounding objects. Source-detector spacings are minimized compared to the mean absorbance path length of light, thereby maximizing the range of sensitivity to particle concentration and enabling discrimination against potentially interfering particles, such as bubbles, is provided. Learn More

A U.S. Patent for a "Method for Producing Metabolites, Peptides and Recombinant Proteins" was awarded to Inria Institut National on November 14th, 2017. The present invention is a method for producing at least one metabolite, peptide, or recombinant protein of interest, said method comprising the steps consisting in: a) culturing bacteria comprising: (i) a gene encoding said recombinant protein or at least one gene encoding an enzyme involved in the production of said peptide or metabolite, wherein said gene is operably linked to a promoter, and (ii) genes encoding the .beta..beta.' subunits of a bacterial RNA polymerase operably linked to an inducible promoter, wherein the promoter operably linked to the genes in (i) and (ii) are not the same, in a first culture medium comprising an inducer of the inducible promoter operably linked to the genes of (ii) and thereby inducing the expression of the genes encoding said .beta..beta.' subunits, thereby inducing bacterial growth; b) culturing said bacteria in a second culture medium lacking the inducer and thereby inhibiting the expression of the genes encoding said .beta..beta.' subunits and inhibiting bacterial growth while the gene encoding said recombinant protein or at least one gene encoding an enzyme involved in the production of said peptide or metabolite continues to be expressed, thereby producing said metabolite, peptide or recombinant protein; c) optionally iterating steps a) and b) successively; and d) optionally recovering said metabolite, peptide or recombinant protein produced by said bacteria. To learn more click here

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A U.S. Patent Application for "Suspension Culture of Human Embryonic Stem Cells" was published by Asterias Biotherapeutics on January 17th, 2019. The present invention is a method for culturing undifferentiated human pluripotent stem (hPS) cells in suspension, the method comprising: a) suspending undifferentiated hPS cells in a cell culture medium comprising basic fibroblast growth factor (bFGF); b) maintaining the hPS cells substantially undifferentiated while culturing in suspension; c) changing the cell culture medium periodically; and d) optionally splitting the culture from time to time, so as to reduce the density of the hPS cells in culture; wherein the hPS cells are not grown attached to a solid substrate. Learn More

A U.S. Patent for "Methods and Compositions for Increased Safety of Stem Cell-Derived Populations" was awarded to MIT on January 15th, 2019. The present invention is a method for reducing residual pluripotent stem cells in an in vitro differentiated cell population, comprising culturing an in vitro differentiated cell population at an oxygen partial pressure that is less than 142 mmHg for at least 1 day and less than 10 days, and harvesting the differentiated cell population after the culturing step; wherein the harvested cell population comprises less than 1 pluripotent stem cell per 10.sup.3 cells, wherein 50% or more of the cells in the in vitro differentiated cell population are positive for at least one differentiation marker before the culturing step. Learn More

A U.S. Patent for a "Bioreactor for the Cultivation of Mammalian Cells" was awarded to Lonza on January 15th, 2019. The present invention is a scalable bioreactor for the cultivation of mammalian cells, the bioreactor comprising: a biocompatible tank or vessel having a volume of between 500 liters and 20,000 liters and at least one top impeller and at least one bottom impeller, wherein the at least one top impeller has a power number between 0.1 and 0.9, wherein the at least one top impeller has a flow number between 0.4 and 0.9, wherein the at least one bottom impeller has a power number between 0.5 and 0.9, wherein an impeller spacing between the at least one top impeller. Learn More

A U.S. Patent Application for "Methods for Purification of Recombinant AAV Vectors" was published by Genzyme on January 10th, 2019. The present invention is a method for isolating a population of recombinant adeno-associated virus (rAAV) particles from in-process impurities in a feedstream, comprising the steps of: (a) (i) contacting a feedstream containing the rAAV particles with an apatite chromatography medium in the presence of polyethylene glycol (PEG), wherein the rAAV particles bind to the apatite chromatography medium; and (ii) eluting the rAAV particles bound to the apatite chromatography medium with an elution buffer... Learn More

A U.S. Patent Application for "Overexpression of N-Glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins" was published by Amgen on January 10th, 2019. The present invention is a method of regulating the high mannose glycoform content of a recombinant protein during a mammalian cell culture process, comprising: transfecting a mammalian host cell to overexpress a protein that is involved in an N-glycosylation pathway, wherein the protein involved in the N-glycosylation pathway is selected from the group consisting of N-acetyl-glucosaminyltransferase-1 (encoded by Mgat1); N-acetyl-glucosaminyltransferase-2 (encoded by Mgat2); a UDP-Galactose transporter encoded by Slc35a2... Learn More