Patents

A U.S. Patent for a "Bioreactor with Condenser" was awarded to Sartorius Stedim on May 21st, 2019. The present invention is a bioreactor with a vessel having at least one gas dissipation duct for gas discharge, the orifice of the gas dissipation duct being connected to a hydrophobic sterile filter and to a condenser arranged between them and having condensation surfaces, a turbulence generator for generating a turbulent flow is arranged in the gas dissipation duct in the region of the condenser. Learn More

A U.S. Patent for a "Computer-Implemented Method for Creating a Fermentation Model" was awarded to Bayer on May 21st, 2019. The present invention is a computer-implemented method for process control of a bioreaction with an organism comprising: creating a model of a bioreaction with an organism, said model including a matrix L, kinetics of macroreactions and model parameters of calculated values, which comprises the following steps: a. defining selected metabolic pathways of the organism, their properties of stoichiometry and reversibility as background knowledge and calculating elementary modes from this input; b. combining the elementary modes. Learn More

A U.S. Patent for a "Flexible Manufacturing System" was awarded to Xoma on May 21st, 2019. The present invention is a unitary structure adapted to be disposed within a housing, comprising: at least one controlled air, sealable, sterilizable cleanroom having an entry point and an exit point; a cleanroom entry portion coupled to and selectively isolated from the cleanroom, the cleanroom entry portion for controlling personnel flow to the cleanroom via the entry point; a cleanroom exit portion coupled to and selectively isolated from the cleanroom and separated from the cleanroom entry portion, the cleanroom exit portion for controlling personnel flow... Learn More

A U.S. Patent Application for "Particles for Use in Acoustic Standing Wave Processes" was published by FloDesign Sonics on May 16th, 2019. The present invention is a method for concentrating particles in a primary fluid at a first location, comprising: flowing a fluid mixture comprising the particles and the primary fluid through an acoustophoretic device that comprises: an acoustic chamber through which the fluid mixture flows; and an ultrasonic transducer including a piezoelectric material that can be driven to create an acoustic wave in the acoustic chamber; and driving the ultrasonic transducer to create the acoustic wave; wherein the acoustic wave concentrates the particles at the first location. Learn More

A U.S. Patent Application for " Automated Control of Cell Culture Using Raman Spectroscopy"  was published by Lonza on May 16th, 2019. The present invention provides the ability to generate generic calibration models, independent of cell line, using inline Raman probes to monitor changes in glucose, lactate, glutamate, ammonium, viable cell concentration (VCC), total cell concentration (TCC) and product concentration. Calibration models were developed from cell culture using two different cell lines producing different mAbs. Developed predictive models, qualified using an independent cell line not used in calibration... Learn More

A U.S. Patent for "Methods of Reducing Level of One or More Impurities in a Sample During Protein Purification" was awarded to MilliporeSigma on May 14th, 2019. The present invention provides novel and improved protein purification processes which incorporate certain types of carbonaceous materials and result in effective and selective removal of certain undesirable impurities without adversely effecting the yield of the desired protein product. Learn More

A U.S. Patent for a "Syringe Containing Stable Aqueous Formulations of Adalimumab" was awarded to Coherus Biosciences on May 14th, 2019. The present invention relates to aqueous pharmaceutical compositions suitable for long-term storage of adalimumab (including antibody proteins considered or intended as "biosimilar" or "bio-better" variants of commercially available adalimumab), methods of manufacture of the compositions, methods of their administration, and kits containing the same. Learn More

A U.S. Patent for a "High Pressure Bioreactor" was awarded to Carnegie Institution on May 7th, 2019. The present invention relates generally to an integrated system, apparatus and method that allows for the continuous culturing of microorganisms under high pressure conditions and at a wide range of temperatures. More specifically, the system is configured to be gas tight and operate under aerobic or anaerobic conditions. The system is also configured to permit periodic sampling of the incubated organisms under such conditions with minimal physical and chemical disturbance inside the reactor and minimal impacts of shear forces on the collected biomass. Learn More

A U.S. Patent for "Recipient for Cell Cultivation" was awarded to Pall on May 7th, 2019. The present invention is a system for cell cultivation, comprising a recipient having an inner compartment for cell growth, the recipient comprising: an outer tubular wall extending in a longitudinal direction, the outer tubular wall delimiting an outer boundary of the inner compartment in a radial direction; first and second ends delimiting the inner compartment at the first outer end and the second outer end of the outer tubular wall; a packing in the inner compartment comprising a fiber matrix... Learn More

A U.S. Patent for " Highly Concentrated Pharmaceutical Formulations"  was awarded to Genentech  on May 7th, 2019. The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. Learn More

A U.S. Patent for " Cell Culture Additives and Their Use for Increased Bioprotein Production from Cells"  was awarded to Air Liquide  on May 7th, 2019. The present invention relates to a method of increasing protein biomolecule production in which a) a cell that produces a heterologous protein biomolecule is cultured, and b) an Additive and/or a source of the Additive is added to the culture medium in an amount sufficient to (i) increase a total yield of the heterologous protein biomolecule secreted into the cell culture media and/or (ii) increase a specific cellular productivity of the heterologous protein biomolecule secreted into the cell culture media. Learn More

A U.S. Patent for an " Apparatus, Method and System for Recording at Least One Variable During a Biological and Chemical Process"  was awarded to PreSens  on May 7th, 2019. The present invention is an apparatus, a method and a system for the parallelized recording of at least one variable during a biological/chemical process are disclosed. A matrix, which has at least one container and which can be positioned on a measurement carrier, is provided to accommodate the liquid samples. A measuring unit, which comprises a controllable radiation source for electromagnetic radiation and at least one sensor for detecting electromagnetic radiation, is fixedly disposed in or on the measurement carrier. Learn More

A U.S. Patent Application for "Direct Selection of Cells Expressing High Levels of Heteromeric Proteins Using Glutamine Synthetase Intragenic Complementation Vectors" was published by Amgen on May 2nd, 2019. The present invention relates to the general field of recombinant expression of polypeptides in animal cell culture. More specifically, the invention concerns improved selection of cells transfected with recombinantly engineered vectors designed to express polypeptides, in particular heteromultimeric polypeptides. Learn More

A U.S. Patent Application for "Compositions and Methods for Regulating Cell Osmolarity" was published by Genentech on May 2nd, 2019. The present invention provides compositions and methods for regulating intracellular osmolarity in cells, e.g., in cultured cells, including in cultured cells in bioreactors. The invention provides nucleic acids comprising at least one osmo-responsive transcriptional regulatory element (OR-TRE), and cells, vectors, products of manufacture, artificial organs or implants and the like containing an osmo-responsive transcriptional regulatory element (OR-TRE). Learn More

A U.S. Patent for " Abrasion Resistant Film for Biocontainers"  was published by MilliporeSigma on April 30th, 2019. The present invention is a biocontainer film enhanced with an abrasion resistant or "cut-proof" substrate. Such substrates can be combined with current biocontainer materials, via various techniques of embedding, coextrusion or laminating, to maintain the cleanliness and low extractables already validated for biotech manufacturing. The substrate of choice may be constructed from materials known to be more resistant to abrasion and sharp razor type cuts or from materials oriented in such a way to prevent puncture to occur. Learn More

A U.S. Patent Application for " Cation Exchange Chromatography Methods"  was published by Bristol- Myers Squibb  on April 25th, 2019. The present invention provides improved methods of protein purification using CEX chromatography. Such methods generally comprise the steps of: contacting a protein of interest (e.g., an antibody) with a cation exchange resin at a first pH, that is less than the pI of the most acidic isoform of the protein of interest, such that the protein of interest binds to the resin; washing the cation exchange resin at a second pH that is greater than the first pH, but less than the p1 of the most acidic isoform of the protein of interest... Learn More

A U.S. Patent Application for a " Method and Apparatus for Quantifying Solutions Comprised of Multiple Analytes"  was published by Finesse on April 25th, 2019. The present invention is a multi-analyte sensor system based on hollow core photonic bandgap fiber and Raman anti-Stokes spectroscopy. The system includes: i) an inlet to introduce an analyte sample into an analyzer chamber which analyzer includes; ii) a measurement system to derive the anti-Stokes spectral peaks and/or spectra of the sample; iii) a set of reference calibrants corresponding to the analytes of which the sample is primarily comprised; iv) a second inlet to introduce said calibrants into the analyzer. Learn More

A U.S. Patent Application for " Inhibition of Protein Degradation for Improved Production" was published by Lonza  on April 25th , 2019.  The present invention discloses methods and compositions useful for evaluating, selecting, identifying, or making a cell or cell line that has improved production capacity for generating higher yields of products and/or improved capacity to produce higher quality products. Products, as described herein, can include a polypeptide that is endogenously expressed by the cell, a recombinant polypeptide that is not endogenously expressed, or a non-naturally occurring recombinant polypeptide. Learn More

A U.S. Patent for a " Magnetic Mixing System and Method" was awarded to Sani-Tech West on April 23rd , 2019. The present invention is a mixing system typically for use in a container for mixing its contents, the mixing system including a cap unit, an extension unit and a magnetic mixing unit that is attached to the cap unit by the extension unit. The magnetic mixing unit can be folded to permit insertion and/or removal of the system via a mouth of the container. The extension unit and magnetic mixing unit connect via a hinge formed by upper and lower hinge portions that meet at a pivot point.  Learn More

A U.S. Patent for a " Chromatography Method"  w as awarded to GE on April 23rd , 2019. The present invention is a method for purification of immunoglobulin containing proteins or parts thereof, from contaminants that are larger than immunoglobulin containing proteins, the method comprising: a) contacting an immunoglobulin containing sample with agarose chromatography beads comprising a lid consisting of agarose modified with hydrolyzed allyl groups and having a thickness of 1-8 .mu.m with a defined pore size and an inner core of defined pore size consisting of agarose modified with an affinity ligand. Learn More

A U.S. Patent for a " Micro Titre Plate"  w as awarded to GE on April 23rd , 2019. The present invention is a micro titre plate comprising a number of wells disposed in a plurality of columns and rows, the wells being filled with the same type of separation matrix, wherein the separation matrix in the wells of the plate has a series of volumes V.sub.1, V.sub.2, . . . V.sub.n distributed according to a specific pattern that does not obey logarithmic or a single degree freedom linear relationship and same separation matrix volume is provided in all the wells of either the same column or the same row in the plate...  Learn More

A U.S. Patent Application for " In Situ Raman Spectroscopy Systems and Methods for Controlling Process Variables in Cell Cultures" w as published by Regeneron on April 18th, 2019. The present invention provides in situ Raman spectroscopy methods and systems for monitoring and controlling one or more process variables in a bioreactor cell culture in order to improve product quality and consistency. The methods and systems utilize in situ Raman spectroscopy and chemometric modeling techniques for real-time assessments of cell cultures, combined with signal processing techniques, for precise continuous feedback and model predictive control... Learn More

A U.S. Patent for a " Cost-Effective Raman Probe Assembly for Single-Use Bioreactor Vessels"  was awarded to Kaiser Optical  on April 16th, 2019. The present invention consists of systems and methods used to couple an optical sampling probe to a port in a single-use bioreactor bag for in-process monitoring. A combination of re-useable and disposable components maintain precision while reducing costs. A disposable barb with an integral window, received by the port of the reaction vessel, is coupled to a re-useable optic component with a focusing lens. A separate focus alignment tool is used to set the lens position to a precise focal point before placement of the optic component into the barb. Learn More

A U.S. Patent for " Stackable Chromatography Column Modules and Flow Control Blocks" was awarded to  GE  on April 16th, 2019. The present invention discloses a flow control block for a stack of chromatography column modules, as well as a stack of chromatography modules comprising at least one flow control block. The flow control block is in a first position or configuration capable of connecting two chromatography column modules, or a chromatography column module and an endpiece, in parallel and in a second position or configuration it is capable of connecting two chromatography column modules, or a chromatography column module and an endpiece, in series. Learn More

A U.S. Patent Application for "Monoclonal Anti-IL-1RACP Antibodies" was published by MAB Discovery on April 11th, 2019. The present invention is a monoclonal antibody that specifically binds the interleukin 1 receptor type 1, or an antigen binding fragment thereof, comprising: a) a heavy chain variable region (VH) comprising CDR1H, CDR2H and/or CDR3H, wherein the CDR1H region comprises an amino acid sequence selected from the group of SEQ ID NO: 155-231, wherein the CDR2H region comprises an amino acid sequence selected from the group of SEQ ID NO: 232-308, and wherein the CDR3H region comprises an amino acid sequence selected... Learn More

A U.S. Patent for " Particle Analyzing Systems and Methods Using Acoustic Radiation Pressure" was awared to Thermo Fisher  on April 9th, 2019.  The present invention is a particle analyzing system, comprising: a flow cell configured to receive a sample stream that comprises a plurality of particles; an acoustic device configured to acoustically focus at least some of the particles within the flow cell; a fluidics system configured to hydrodynamically focus at least some of the plurality of particles within the flow cell; a controller configured to automate an aspect of the particle analyzing system operation; and, a monitor configured to monitor at least some of the plurality of particles... Learn More

A U.S. Patent for a " Bioreactor Arrangement, Shaking Device and Method for Irradiating a Medium in a Bioreactor"  was published by Sartorius Stedim on April 9th, 2019. The present invention is a bioreactor arrangement that has a bioreactor and an illuminating body for illuminating a medium in a reactor interior. The illuminating body has at least one emission surface via which light, reflected by at least one end surface into the reactor interior, is emitted. The bioreactor is formed as a container having a transparent wall. A shaking device has a reactor holder that can be in oscillated, for a bioreactor with a transparent wall. Learn More

A U.S. Patent Application for " Single-Pass Filtration Systems and Processes"  was published by MilliporeSigma on April 4th, 2019. The present invention provides, in various embodiments, hybrid single-pass tangential flow filtration assemblies, disposable single-pass TFF assemblies, scalable single-pass TFF assemblies and adaptable modular single-pass TFF assemblies. In other embodiments, the invention relates to processes for recovering proteins from the surface of a filtration membrane in a single-pass TFF assembly and for cleaning a TFF assembly. In additional embodiments, the invention provides methods of increasing the processing capacity of a single-pass TFF assembly. Learn More

A U.S. Patent for a " Flow Regulator as well as Method for Setting a Predefinable Volume Flow"  was awarded to Levitronix on April 2nd, 2019. The present invention is a flow regulator that includes a first sensor determining a first actual value of a first flow parameter of the fluid, a pre-pressure regulator setting a predefinable pre-pressure at a pre-pressure outlet of the pre-pressure regulator, and a regulating pump. The fluid is capable of being supplied to the pre-pressure regulator at a plant pressure in an operating state via an inflow line and a pre-pressure inlet and capable of being conducted further to the regulating pump at the pre-pressure. Learn More

A U.S. Patent for a " Fluid Transfer Device"  was awarded to MilliporeSigma on April 2nd, 2019. The present invention is a disposable device for the sterile transfer of fluids, such as liquids or gases, includes a body, a bore formed through at least a portion of the interior of the body, and a linearly moveable plunger contained within the bore. The body is formed from a rotating section and a stationary section. Partial rotation of the rotating section around a portion of the stationary section and the plunger drives the plunger linearly within the bore, opening and closing the device. The plunger includes at least a first and a second opening, and a fluid channel in the interior of the plunger. Learn More

A U.S. Patent Application for an " Optically Clear Sealable Petri Dish Bioreactor"  was published by Autobiologic on March 28th, 2019.  The present invention is a petri dish bioreactor that can allow a standard Petri dish to be converted to a microscopically observable bioreactor. One advantage of this conversion is to provide an inexpensive device that can be used for cell culture, observation, transportation, and storage in the laboratory and clinical setting. Further, by creating a sealed bioreactor chamber accessible by ports, the device can reduce cross contamination and allow for the maintenance of a controlled microenvironment within the bioreactor. Learn More

A U.S. Patent Application for a " Scalable Primate Pluripotent Stem Cell Aggregate Suspension Culture and Differentiation Thereof"  was published by Viacyte on March 28th, 2019. The present invention relates to suspension cell aggregate compositions that are essentially serum and feeder-free and methods for differentiating the cell aggregate suspensions. It further relates to methods for production of undifferentiated or differentiated embryonic stem cell aggregate suspension cultures from undifferentiated or differentiated embryonic stem cell single cell suspensions and methods of differentiation thereof. Learn More

A U.S. Patent Application for an "Improved Fermentation Process" was publsihed by Lonza on March 28th, 2019. The present invention is a method for producing a recombinant protein of interest (POI) comprising: (a) culturing cells in a cell culture medium to express said POI by adding a feed comprising at least one substrate to said cell culture, (b) applying a feeding strategy based on calculating, setting and optionally controlling the specific substrate uptake rate q.sub.S of the cells during the induction phase and/or production phase of the POI, wherein q.sub.S is set to be close to the maintenance rate of the cell culture; and (c) isolating said POI from the cell culture. Learn More

A U.S. Patent for a "Method for the Production of Protein Complexes and Vaccine Compositions Comprising the Same" was awarded to Immunobiology on March 26th, 2019. The present invention relates to methods for the production of heat shock protein complexes for use in vaccine compositions. In particular, there is provided a method for increasing the level and immunogenicity of heat shock protein complexes produced in cells by subjecting the cells to specific stress-inducing stimuli. The invention further extends to the use of heat shock protein complexes produced. Learn More

A U.S. Patent for a "Bioreactor Container and Integrity Check Method for Bioreactor Containers" was awarded to Sartorius Stedim on March 26th, 2019. The present invention is a bioreactor container comprising: an at least locally flexible wall that has a fluid-impermeable inner sheet and an at least locally structured outer sheet, the structured outer sheet being configured to separate the fluid-impermeable sheet from an object outside the bioreactor container so that the object from outside the bioreactor container does not come in direct mechanical contact with the fluid-impermeable inner sheet and so that a leak in the fluid-impermeable inner sheet cannot be sealed by the object. Learn More

A U.S. Patent Application for "Production of Extracellular Vesicles in Single-Cell Suspension Using Chemically-Defined Cell Culture Media" was published by Codiak BioSciences on March 21st, 2019. The present invention are methods for the production of extracellular vesicles comprising culturing a population of producer cells in single-cell suspension, wherein the cells are cultured in chemically-defined culture medium, wherein the culture medium lacks animal-derived serum and animal-derived components; and obtaining from the cell culture an extracellular vesicle preparation comprising extracellular vesicles. Learn More

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 a " Batch Authoring Tool and Bioreactor Control System"  was awarded to GE on March 19 th , 2019. The present invention is a bioreactor control system comprising a batch server for controlling a bioreactor system in response to a recipe, a batch software system for generating a control sequence for the bioreactor system via the batch server for implementing the recipe, and a recipe conversion system that inputs the recipe into the batch software system. Preferably, the recipe conversion system reads a word processor file containing the recipe and interprets styles applied to text in the word processor file as indicating equipment and phases of the recipe to the recipe conversion system. 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