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A mathematical mass-transfer model was developed based on the mass balance of gas exchange in cell culture bioreactors. The model combines the bioreactor mass transfer properties and mammalian cell metabolic parameters to predict the cell culture process oxygen demands and carbon dioxide accumulation in bioreactors. With the guidance of the mass-transfer model, a CHO cell culture process to produce a therapeutic antibody was successfully scaled up from 2-L to 1500-L bioreactor directly without intermediate steps. The process performances and product quality attributes demonstrate good robustness and consistency between small and large scales. This mass-transfer model provides a more systematic and reliable approach for mammalian cell culture bioreactor scaling up. Learn More

Hybrid cell lines arise through intentional or non- intentional fusion of somatic cells having different origins. Hybrid cell lines can pose a problem for authentication testing to confirm cell line identity, since the results obtained may not conform to the results expected for the two parental cell types. Thus, depending on the identity testing methodology, a hybrid cell may display characteristics of one of the parental cell type or of both. In some instances, the hybrid cell line may display characteristics that are different from those displayed by either parental cell type; these differences may not necessarily indicate cellular cross-contamination... Learn More

Perfusion processes typically require removal of a continuous or semi-continuous volume of cell culture in order to maintain a desired target cell density. For fast growing cell lines, the product loss from this stream can be upwards of 35%, significantly reducing the overall process yield. As volume removed is directly proportional to cell growth, the ability to modulate growth during perfusion cell culture production thus becomes crucial. Leveraging existing media components to achieve such control without introducing additional supplements is most desirable because it decreases process complexity and eliminates safety and clearance concerns. Here, the impact of extracellular concentrations of sodium (Na) and potassium (K) on cell growth and productivity is explored. Learn More

A current challenge in bioprocessing is the ability to analyse critical quality attributes such as aggregation without prior purification. This study evaluated the use of fluorescent dyes (Bis-ANS, SYPRO Orange, Thioflavin T and ProteoStat) to characterise mAb aggregates in Chinese hamster ovary clarified cultures. The null and mAb culture supernatants showed an increase in fluorescence intensity over the duration of the culture. The null cultures on day 14 saw a rapid increase in fluorescence intensity; day 10 to day 14, Bis-ANS and Thioflavin T had average increases of 21% and 48%, respectively, whereas ProteoStat and SYPRO Orange showed an average increase of 60%. Higher fluorescence intensity on day 14 with the null cultures, also correlated with loss of viability. Learn More

With approximately half of bioprocessing industry professionals choosing aseptic connectors and the other half choosing tube welders, how do you know which connection type is right for you? Read our tech guide to learn more about key factors to consider when comparing tube welders and aseptic connectors, so you can make the correct choice for your needs.



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A mathematical mass-transfer model was developed based on the mass balance of gas exchange in cell culture bioreactors. The model combines the bioreactor mass transfer properties and mammalian cell metabolic parameters to predict the cell culture process oxygen demands and carbon dioxide accumulation in bioreactors. With the guidance of the mass-transfer model, a CHO cell culture process to produce a therapeutic antibody was successfully scaled up from 2-L to 1500-L bioreactor directly without intermediate steps. The process performances and product quality attributes demonstrate good robustness and consistency between small and large scales. Learn More

Just days after the U.S. FDA joined the EMA and Health Canada in announcing a second impurity, called NDEA, has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals the FDA has released a third Form 483 to the company. Following inspections in July and August, the FDA issued the 483 with 11 observations, with perhaps not surprisingly specific issues raised about the firm's quality unit. The FDA also found the firm's change control system, designed to evaluate all changes that may affect production to be inadequate. Learn More

Capacitance has been used to monitor "biomass" in cell culture and fermentation processes for several decades. The present work explored various ways to support GMP use and create robust methods that would assure proper performance of capacitance equipment. The first goal was to develop a method for measuring at-line capacitance that could serve to correct or confirm online measurements from bioreactors. With appropriate control of culture temperature, vessel geometry, mixing, and timing; an at-line system was developed that consistently predicted online capacitance outputs. The at-line method yielded values that differed systematically from online values... Learn More

In this study, we investigated the effects of ATF cell separation on high-density perfusion cultures. We have developed methods to estimate theoretical residence times of cells in the ATF system and discovered that long residence times (above 75 seconds) correlate with decreased growth, metabolism and productivity. We have calculated energy dissipation rates in the ATF transfer line and filter and empirically studied the impacts of increased exchange rates on cell culture, determining that increased hydrodynamic stress can lead to decreased cell size, lactate production and specific productivity. Finally, we have conducted experiment... Learn More

A universal flu vaccine that protects people against most influenza strains is one step closer to reality, with a study from the Perelman School of Medicine at the University of Pennsylvania. The candidate vaccine, described in Nature Communications this week, elicited a strong antibody response to a structure on the surface of flu viruses, called the hemagglutinin (HA) stalk. It protected mice from infection by various flu strains. "This vaccine was able to do something that most other candidate flu vaccines have not been able to do," said study co-senior author Drew Weissman, MD, PhD, a professor of Infectious Diseases. "It was able to elicit protective responses against a conserved region that offers broad protection." Learn More

Research led by a Salk Institute scientist suggests why, at a cellular level, this might be true. The team reports that brief exposures to stressors can be beneficial by prompting the cell to trigger sustained production of antioxidants, molecules that help get rid of toxic cellular buildup related to normal metabolism. The research, which appeared in the journal Cell Metabolism this week, also revealed that short-term stress to cells leads to remodeling mitochondria, the powerhouses of the cell that deteriorate with age, so they generate fewer toxic byproducts. The findings could lead to new approaches to counter the cellular effects of aging, possibly even extending lifespan. Learn More

A critical quality attribute of therapeutic monoclonal antibodies (mAbs) is the terminal sugar molecules of the N-linked glycan attached to the fragment crystalizable (Fc) region. There exists naturally-occurring heterogeneity in the N-linked glycan structure of mAbs, and such heterogeneity has a significant influence on the clinical safety and efficacy of mAb drugs. We previously proposed a constraint-based modeling method called glycosylation flux analysis (GFA) to characterize the rates (fluxes) of intracellular glycosylation reactions and applied the method to examine the N-linked glycosylation of immunoglobulin G (IgG) in fed-batch Chinese hamster ovary (CHO) fed-batch cultivations. Learn More

Yes. Recently a single-use manifold for fluid transfer was introduced to our community that in itself does not require the use of Y connectors, stopcocks and the like. It fits 3/8" tubing ID's and is capable of a max pressure of 15 psi. No word yet if there are plans to accommodate different tubing ID's or if an automated version is in the works.

Nordson CYLINDRAFlow™ Manifolds

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Recently, the importance of biopharmaceuticals in medical treatments has been increasing, and effective protein purification methods are strongly required for their production. In the present study, a temperature-responsive solid-phase extraction (SPE) column was developed for the purification of proteins without affecting their bioactivity. A temperature-responsive polymer hydrogel-modified stationary phase was prepared by coating aminopropyl silica beads with poly(N-isopropylacrylamide) (PNIPAAm)-based thermoresponsive hydrogels.n-Butyl methacrylate and acrylic acid were copolymerized with PNIPAAm as hydrophobic and anionic monomers, respectively. Learn More

A new integrated continuous biomanufacturing platform for continuous production of antibodies at fixed cell volumes and cell concentrations for extended periods with immediate capture is presented. Upstream antibody production has reached technological maturity, however, the bottleneck for continuous biomanufacturing remains the efficient and cost-effective capture of therapeutic antibodies in an initial chromatography step. In this study, the first successful attempt at using one-column continuous chromatography (OCC) for the continuous capture of therapeutic antibodies produced through alternating tangential flow perfusion is presented... Learn More

In an achievement that has significant implications for research, medicine, and industry, UC San Francisco scientists have genetically reprogrammed the human immune cells known as T cells without using viruses to insert DNA. The researchers said they expect their technique -- a rapid, versatile, and economical approach employing CRISPR gene-editing technology -- to be widely adopted in the burgeoning field of cell therapy, accelerating the development of new and safer treatments for cancer, autoimmunity, and other diseases, including rare inherited disorders. The new method, described in the July 11, 2018 issue of Nature, relies on electroporation. Learn More

Recent research led by Professor G.V. Shivashankar of the Mechanobiology Institute (MBI) at the National University of Singapore (NUS) and the FIRC Institute of Molecular Oncology (IFOM) in Italy, has revealed that mature cells can be reprogrammed into re-deployable stem cells without direct genetic modification, this is accomplished by confining them to a defined geometric space for an extended period of time. "Our breakthrough findings will usher in a new generation of stem cell technologies for tissue engineering and regenerative medicine that may overcome the negative effects of geonomic manipulation," said Prof Shivashankar.
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The U.S. FDA this week published a warning letter sent to China based Zhuhai United Laboratories for significant deviations from CGMP for API. The FDA inspectors found the manufacturer lacked adequate procedures for investigating, and scientific justification to invalidate, out-of-specification (OOS) results.The warning letter also cites the API manufacturer for failing to adequately investigate findings from a February 2015 retrospective review of analytical chromatography data irregularities. FDA inspectors also found additional examples of incomplete data relating to Zhuhai's sterile manufacturing operations evaluated as part of FDA's pre-approval inspection. Learn More

The measurement of the flow of liquids associated with bioprocessing has long been sought, and largely addressed, for the most part. The exception being the accurate and reliable measurement of liquid at ultra-low flow. However, this is fast becoming recognized by our industry as an exception no more. The Sonoflow IL sensors have proven capable of delivering the precise measurement (+/- 1%) of flow ranges below 10ml/min. These sensors accomplish this while complying with the first rule of bioprocessing when it comes to the cells, "do no harm". Learn More

The applications of mass spectrometry in the pharmaceutical industry have long been established. Mass spectrometers are highly versatile and commonly used to identify reagents, products, contaminants, and impurities from samples in drug research and development, scale-up, and high volume manufacturing lines. However, the instruments are normally large, power demanding, and expensive pieces of equipment operated in centralized laboratories by MS specialists. The new demands of bioprocessing, used to make biologics, means that there is a need for analytical instruments, such as mass spectrometers, to provide real-time information (on-line and at-line) at the point-of-need. Learn More

The U.S. FDA this week finalized its guidance to help sponsors understand how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs). The 32-page final guidance contains clarifications to the draft guidance of the same title that published in October 2017, the agency says. The GDUFA II Commitment Letter includes changes in the classification of and review goals for amendments to ANDAs and PASs under GDUFA I, when amendments got classified into a Tier-based system. Learn More

The effectiveness of antibiotics can be altered by combining them with each other, non-antibiotic drugs or even with food additives. Depending on the bacterial species, some combinations stop antibiotics from working to their full potential whilst others begin to defeat antibiotic resistance, report EMBL researchers and collaborators in Nature on July 4th, 2018. In the first large-scale screening of its kind, scientists profiled almost 3000 drug combinations on three different disease-causing bacteria. The research was led by EMBL group leader Nassos Typas. Learn More

Mylan's manufacturing facility in Morgantown, WV, has received an FDA Form 483 listing inspectional observations, some of which were due to failures of its quality control unit.
Agency investigators who visited the firm during a 12-day site inspection earlier this year, noted 13 situations of noncompliance to good manufacturing practices in the 32-page Form 483. From a lack of appropriate oversight and documentation on written procedures changes to an inadequately validated cleaning process and established time limits on drug products, seven observations described the firm's quality control unit. Learn More

In a hard hitting article published in ProPublica this week, the author argues that with biopharma underwriting roughly 75% of the FDA's budget for scientific reviews, it is perhaps not a coincidence that the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits. She notes that once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, the FDA reviewed NDA's more than 60 days faster on average than did its couterparets at the EMA. Learn More

Viral inactivation plays a critical role in assuring the safety of mAb therapeutics. Traditional viral inactivation involves large holding tanks in which product is maintained at a target low pH for a defined hold time, typically 30-60 minutes. The drive toward continuous and improved facility utilization has provided motivation for development of a continuous viral inactivation process. To this end, a lab-scale prototype viral inactivation system was designed, built, and characterized. Multiple incubation chamber designs are evaluated to identify the optimal design that enables narrow residence time distributions in continuous flow systems... Learn More

This work is a proof of concept of how a sequence of industrial batch separation steps together are used to form an integrated autonomous downstream process. The sequence in this case study consisted of an anion chromatography step, virus inactivation and finally a hydrophobic chromatography step. Moving from batch to integrated separation minimizes hold-up times, storage tanks, and required equipment. The conversion from batch to integrated mode is achieved by extracting operating points and separation data from batch chromatograms. The integrated separation process is realized on an ÄKTA Pure controlled by an open research software... Learn More

Researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences have developed an oral delivery method that could dramatically transform the way in which diabetics keep their blood sugar levels in check. By encapsulating the insulin-ionic liquid formulation in an enteric coating, the team overcame the challenge of resisting a breakdown by gastric acids in the gut. This polymer coating dissolves when it reaches a more alkaline environment in the small intestine, where the ionic liquid carrying insulin is released. The research was published in the Proceedings of the National Academy of Sciences. Learn More

The U.S. FDA has warned Chinese API manufacturer Henan Lihua Pharmaceutical Co. Ltd. for good manufacturing practice (GMP) violations stemming from an inspection last December. During the inspection, the FDA says its on-site investigators observed lapses in oversight by the company's quality unit and deviations related to record keeping at the Henan province-based facility. These issues resulted in the agency placing the company on import alert in March. The FDA also says the company rubber stamped manufacturing records and did not control access to those forms or the stamps. Learn More

Cancer researchers at KU Leuven in Belgium have shown that some patients with T-cell leukemia produce too much of the BCL-2 protein. The overproduction of the BCL-2 protein is due to a defect in the ribosome, the protein factory of the cell. This defect is found in 10% of the pediatric patients with T-cell leukemia. Cancer cells take advantage of this 'survival protein' which allows them to escape chemotherapy. The impact of this ribosome defect on T-cell leukemia has never been elucidated before. A drug suppressing this BCL-2 shows promising results. Learn More

The U.S. FDA this week approved the country's first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy. The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes. The FDA's decision was expected after an advisory panel had unanimously recommended it. Learn More

The Trump administration has proposed a fundamental change to the mission of the U.S. Food and Drug Administration, one that would transfer most of the responsibility for regulating food safety to the Department of Agriculture and rename the FDA the "Federal Drug Administration." The idea of changing a key mission of the FDA comes amid a turf war between the FDA and the USDA. The two agencies have recently battled over who gets to regulate lab-grown meat, Politico reported last week. And in May, FDA Commissioner Scott Gottlieb spoke about the importance of his agency regulating genetically engineered animals. Learn More

In response to industry concerns, the U.S. FDA this week announced it has withdrawn its draft guidance on evaluating studies used to demonstrate analytical similarity between a biosimilar and reference biologic.The FDA says it plans to reissue the draft guidance after considering changes to the document that will "promote a more efficient pathway for the development of biosimilar products."To date, the FDA has approved 11 biosimilars to eight reference biologics since approving its first biosimilar in 2015. However, only a fraction of those biosimilars are available on the market, with legal challenges often adding years between approval and commercial launch. Learn More

Herein, we showed for the first time that exosomes, which are nano-sized extracellular vesicles, derived from CHO cells inhibited apoptosis in CHO cell culture when supplemented to the culture medium. Flow cytometric and microscopic analyses revealed that substantial amounts of exosomes were delivered to CHO cells. Higher cell viability after staurosporine treatment was observed by exosome supplementation (67.3%) as compared to control (41.1%). Furthermore, exosomes prevented the mitochondrial membrane potential loss and caspase-3 activation, meaning that the exosomes enhanced cellular activities under pro-apoptotic condition... Learn More

To date, integrated continuous bioprocessing has not been realized as enabling technologies are nascent. In this work, a fully integrated continuous process is successfully demonstrated from pilot scale bioreactor to drug substance. Comparable product quality is observed between the continuous process and a 500 liter fed-batch conventional process. A throughput analysis shows that a fed-batch facility with four x twelve five hundred liter liter stainless steel bioreactors and purification train of the corresponding scale can be replaced by a continuous facility consisting of five x two thousand liter single use bioreactors and smaller purification train, with a cost reduction of 15%. Learn More

Ziopharm Oncology has announced that the U.S. FDA has placed a clinical hold on a Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care and requested additional information in support of the investigational new drug (IND) application for the trial. The FDA has requested additional information relative to Chemistry, Manufacturing and Controls. Ziopharm and its partners will address the FDA's requests, and the initiation of this trial may be delayed. Learn More

Researchers at Columbia University Irving Medical Center (CUIMC) have developed a highly innovative computational framework that can support personalized cancer treatment by matching individual tumors with the drugs or drug combinations that are most likely to kill them. The study, published this week on Nature Genetics, by Dr. Andrea Califano of Columbia University Irving Medical Center and Dr. Irvin Modlin of Yale University and Wren Laboratories LLC, co-senior author on the study, with collaborators from 17 research centers worldwide, details a proof of concept for a novel analytical platform applicable to any cancer type.
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With the publication of a final guidance, the U.S. FDA has adopted the International Council for Harmonization's (ICH) questions and answers guideline on the nonclinical evaluation of drugs intended to treat cancer.The final guidance comes less than two months after ICH advanced the document for international implementation in late April. The guideline, which contains 41 questions and answers aimed at providing additional clarity about oncology drug development, is meant to be read alongside ICH's 2009 guideline S9 Nonclinical Evaluation for Anticancer Pharmaceuticals. Learn More

Biologic manufacturing processes typically employ clarification technologies like depth filtration to remove insoluble and soluble impurities. Conventional depth filtration media used in these processes contain naturally-derived components like diatomaceous earth and cellulose. These components may introduce performance variability and contribute extractable/leachable components like beta-glucans that could interfere with limulus amebocyte lysate endotoxin assays. Recently a novel, all-synthetic depth filtration media is developed (Millistak+® HC Pro X0SP) that may improve process consistency, efficiency, and drug substance product quality by reducing soluble process impurities... Learn More

San Carlos city officials this week approved a developer's proposal to update designs for two buildings currently under construction on the city's east side. Previously dubbed Meridian 25, the project involves a proposal to build a 530,000-square-foot office complex at Industrial and Bransten roads. Sold to Alexandria Real Estate Equities in 2017, the property has been slated for the real estate company's specialty in life sciences but required officials' approval to make changes to the previously-approved design and accommodate biotech R&D there, according to Community Development Director Al Savay. Learn More

A grand jury has indicted CEO Elizabeth Holmes and her former No. 2 Sunny Balwani for alleged fraud at Theranos, the disgraced Silicon Valley company that once promised to revolutionize blood testing in a pitch that was too good to be true. The criminal charges filed by federal prosecutors allege that Holmes and Balwani bilked investors out of hundreds of millions of dollars while also defrauding doctors and patients through years of lies that put thousands of people in personal danger. Holmes is also out as CEO, the company announced in a statement. David Taylor, the company's general counsel, will take over as CEO. Holmes remains chairman of the company's board. Learn More

To fight cancer, researchers increasingly use vaccines that stimulate the immune system to identify and destroy tumor cells. However, the desired immune response is is not always guaranteed. In order to strengthen the efficacy of vaccines on the immune system -- and in particular on T lymphocytes, specialized in the detection of cancer cells -- researchers from the universities of Geneva (UNIGE), Freiburg (UNIFR), Munich, and Bayreuth, in collaboration with the German company AMSilk, have developed spider silk microcapsules capable of delivering the vaccine directly to the heart of immune cells. This process, published in the journal Biomaterials, could also be applied to preventive vaccines... Learn More

Protein biologics have emerged as a safe and effective group of drug products that can be used in a variety of medical disorders and clinical settings, including treatment of orphan diseases, personalized medicine, and point-of-care applications. However, the full potential of protein biologics for such applications will not be realized until there are methods available for rapid and cost-effective production of small scale products for individual needs. Here, we describe a modular and scalable method for rapid and adaptable production of protein-based medical products at small doses. The method includes cell-free synthesis of the protein target in a reactor module... Learn More

Mylan has announced that the U.S. FDA will issue a Complete Response Letter for the drugmaker's generic version of GlaxoSmithKline's Advair Diskus on June 27th, 2018. The generic drugmaker said the agency "identified minor deficiencies" that will be communicated in the CRL. Once the official rejection is received, Mylan will determine what impact it will have on its financial outlook for the year. Mylan was quick to point out the abbreviated New Drug Application for the generic asthma drug had a priority review and could be approved ahead of the 90-day period typical after a response to a CRL, suggesting the generic could still be approved this year. Learn More

The New Jersey Economic Development Authority has approved a 10-year, $40 million tax savings incentive package for Teva Pharmaceuticals to move its domestic headquarters to Parsippany, NJ from Pennsylvania. The tax credits would be conditional upon the company preserving 1,000 jobs via a combination of new hires and retention of existing jobs. The move is expected to bring 843 jobs to New Jersey, while keeping 232 the company already has in Parsippany. Teva is considering moving into a 345,000-square-foot space at 400 Interpace Parkway and out of its current space in Frazer, a town just outside of Philadelphia.
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As part of an effort spur the development of new antimicrobial drugs intended for limited patient populations, the U.S. FDA this week issued a draft guidance with recommendations for demonstrating the safety and effectiveness of such drugs. In recent years, the U.S. Congress has attempted to address shortfalls in the development of new antimicrobial drugs as resistance to existing drugs mounts and questions about the economic viability of new antimicrobial drugs loom."...there has unfortunately been an overall decline in antibiotic drug research driven largely by the significant obstacles to developing innovations in this category," FDA Commissioner Scott Gottlieb said. Learn More

Eisai has announced that it will close its existing site in Andover in early 2019 and launch the Eisai Center for Genetics Guided Dementia Discovery in Cambridge, Massachusetts. The Center will be located in a new, dedicated state-of-the-art facility and be funded by a $100 million investment over the first three years. This will be followed by what the company anticipates to be substantially increased funding requirements as its pipeline develops with a new drug expected to have been discovered at the Center by 2020. The new 50,000-square-foot facility is being constructed in the Alewife Research Center. Learn More

The prominent cancer biologist Inder Verma, a researcher at the Salk Institute for Biological Studies in San Diego since 1974, has unconditionally resigned and his resignation accepted. This comes after Salk hired a leading San Diego employment law firm earlier this year to investigate reports of several allegations of sexual harassment against Verma, 70, a pioneer in gene therapy and oncogene research. It was later learned that no fewer than eight women, six of them affiliated with Salk, had reported incidents of harassment spanning 40 years. For his part, Verma has denied the allegations in a written statement. Learn More

Editing cells' genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published this week warn - a potential game-changer for the companies developing CRISPR-based therapies. In the studies, published in Nature Medicine, scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient. That could make some CRISPR'd cells ticking time bombs, according to researchers from Sweden's Karolinska Institute and, separately, Novartis. Learn More

The Scottish government has dismissed the possibility of using compulsory licensing to get a copy of Roche's breast cancer drug Perjeta to patients. A politician floated the idea of enacting a Crown use licence to bypass the pricing impasse that is stopping HER2-positive secondary breast cancer patients from accessing the biologic but has struggled to garner support at the top. Roche tried to secure reimbursement for the drug last year but the Scottish Medicines Consortium (SMC) ruled it was "very expensive" and a poor use of limited healthcare resources. Since then, Roche has met with Scottish officials with a view to coming to an agreement but is yet to file a new submission. Learn More

To meet the ever-growing demand for effective, safe, and affordable protein therapeutics, decades of intense efforts have aimed to maximize the quantity and quality of recombinant proteins produced in CHO cells. Bioprocessing innovations and cell engineering efforts have improved product titer; however, uncharacterized cellular processes and gene regulatory mechanisms still hinder cell growth, specific productivity, and protein quality. Herein, we summarize recent advances in systems biology and data-driven approaches aiming to unravel how molecular pathways, cellular processes, and extrinsic factors (e.g. media supplementation) influence recombinant protein production... Learn More

Roche has been given fast-track review by the U.S. FDA this week for its Hemlibra treatment for people with a form of haemophilia. The Basel company said the FDA has granted priority review for the drug for children and adults with hemophilia A without factor VIII inhibitors, with a decision on approval expected on October 4, 2018. Hemlibra had already received breakthrough therapy designation for the medicine to be used in people who have not yet developed resistance to conventional treatments, called inhibitors, Roche said in April. Learn More

Janet Woodcock, Director of the U.S. FDA's CDER, has made public her recently proposed changes to CDER's new drug regulatory program. In which she notes that these changes are intended to free up resources so that her scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities. The proposals include regulatory and review process changes, organizational restructuring and improved support structures. Learn More

Investors shaved billions off Nektar Therapeutics' valuation this week on news of disappointing data in its latest clinical trial update. The latest trial data suggests that melanoma patients aren't responding to the experimental treatment as well as an earlier batch of patients did. That glowing initial data revealed last fall helped propel Nektar to a market value that topped $15 billion just last week. Alert readers will recall that Nektar signed a research partnership earlier this year with Bristol-Myers that netted the startup a whopping nearly $2 billion upfront payment. Learn More

The U.S. FDA has announced the capability of two additional EU member states, Lithuania and Ireland, to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US, the European Medicines Agency (EMA). Fourteen EU member states are now included in an agreement that allows the FDA to rely on their inspection results to replace their own inspections. Last June, the European Commission confirmed that FDA has the capability, capacity, and procedures to carry out GMP inspections at a level equivalent to the EU. Learn More

The U.S. FDA this week approved its 11th biosimilar, the first competition for Amgen's Neulasta, and known as Mylan's Fulphila. Also this week, the FDA released a new draft guidance on formal meetings between biosimilar sponsors and the agency, replacing a previous guidance from November 2015.The 21-page draft, completed as part of the second iteration of the biosimilar user fee goals, features sections on the four types of biosimilar biological product development (BPD) meetings - biosimilar initial advisory (BIA), Type 1, Type 2, Type 3 and Type 4. Learn More

The U.S. FDA has placed a clinical hold on CRISPR Therapeutics' lead candidate, spurring a double-digit drop in the company's stock value this week. The hold targets the Investigational New Drug application for CTX001, an ex vivo gene-editing therapy that CRISPR and partner Vertex are testing as a treatment for sickle cell disease in the U.S. and beta-thalassemia in Europe. CRISPR and Vertex said they are awaiting more information from the FDA about the rationale behind its hold. The drugmakers received a thumbs up from European regulators earlier this year to start a trial of CTX001, and plans for that Phase 1/2 study remain "unchanged". Learn More

Amgen has announced that the FDA has issued a Complete Response Letter (CRL) for its Herceptin biosimilar, ABP 980. In a brief statement on its website, Amgen said that it would work closely with the FDA on the product and that it did not expect the CRL to impact its US launch plans. Amgen and its partner, Allergan, submitted their Biologics License Application for the drug in August 2017. Amgen previously released complete phase 3 results from a study in patients with HER2-positive early breast cancer at the 2017 annual meeting of the European Society for Medical Oncology in Madrid, Spain. Learn More

In recent years, cell-based therapies targeting the immune system have emerged as promising strategies for cancer treatment. This review summarizes manufacturing challenges related to production of antigen presenting cells as a patient-tailored cancer therapy. Understanding cell-material interactions is essential because in vitro cell culture manipulations to obtain mature antigen-producing cells can significantly alter their in vivo performance. Traditional antigen- producing cell culture protocols often rely on cell adhesion to surface-treated hydrophilic polystyrene flasks. More recent commercial and investigational cancer immunotherapy products were manufactured using suspension cell culture in closed hydrophobic fluoropolymer bags. The shift to closed cell culture systems can decrease risks of contamination by individual operators, as well as facilitate scale-up and automation. Selecting closed cell culture bags over traditional open culture systems entails different handling procedures and processing controls, which can affect product quality. Changes in culture vessels also entail changes in vessel materials and geometry, which may alter the cell microenvironment and resulting cell fate decisions. Strategically designed culture systems will pave the way for the generation of more sophisticated and highly potent cell-based cancer vaccines. As an increasing number of cell-based therapies enter the clinic, the selection of appropriate cell culture vessels and materials becomes a critical consideration that can impact the therapeutic efficacy of the product, and hence clinical outcomes and patient quality of life.



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05/01/2018

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The U.S. FDA has published an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for biopharma lifecycle management. The 34-page draft aims to help facilitate the successful management of post-approval chemistry, manufacturing and controls (CMC) changes for new and marketed biopharma drug substances and drug products.
The draft features a decision tree on established conditions for manufacturing and control, noting when notification or prior approval is necessary based on the level of potential risk of a proposed change. Learn More

The manufacturing of recombinant protein is traditionally divided in two main steps: upstream (cell culture and synthesis of the target protein) and downstream (purification and formulation of the protein into a drug substance or drug product). Today, cost pressure, market uncertainty and market growth, challenge the existing manufacturing technologies. Leaders in the field are active in designing the process of the future and continuous manufacturing is recurrently mentioned as a potential solution to address some of the current limitations. This review focuses on the application of continuous processing to the first step of the manufacturing process... Learn More

The U.S. FDA has placed a clinical hold on CRISPR Therapeutics' lead candidate, spurring a double-digit drop in the company's stock value this week. The hold targets the Investigational New Drug application for CTX001, an ex vivo gene-editing therapy that CRISPR and partner Vertex are testing as a treatment for sickle cell disease in the U.S. and beta-thalassemia in Europe. CRISPR and Vertex said they are awaiting more information from the FDA about the rationale behind its hold. The drugmakers received a thumbs up from European regulators earlier this year to start a trial of CTX001, and plans for that Phase 1/2 study remain "unchanged". Learn More

The U.S. FDA issued a Warning Letter citing GMP violations, flagged during a four-day FDA site inspection last November, to Jilin Shulan Synthetic Pharmaceutical. Among the issues cited is a lack of documentation for deviations in the firm's laboratory testing results, insufficient data-protection controls on its chromatography computer systems as well as record-keeping delays when performing manufacturing operations.
Inadequate handling of data generated on the firm's computerized systems, such as the use of a portable drive that was not password-protected, was cited as well. Learn More

Researchers at the University of Pennsylvania's Abramson Cancer Center say a patient treated for chronic lymphocytic leukemia (CLL) in 2013 went into remission because of a single CAR T cell and the cells it produced as it multiplied, and has stayed cancer free in the five years since, with CAR T cells still present in his immune system. The findings, published this week in Nature, show the response is tied to where the CAR gene inserted itself into the patient's T cell DNA, a key factor that may help improve response rates to the therapy. Learn More

The World Health Organization (WHO) is stepping in to assess the quality of biosimilars, offering a global stamp of approval that could make them more widely available, while also raising the quality bar. After a nine-month delay, the UN agency plans to invite drugmakers in June to submit dossiers on biosimilar versions of two cancer drugs on its essential medicines list, Roche's Rituxan and Herceptin. This comes after researchers at Pfizer reported in a scientific journal that batches of seven intended biosimilars of its arthritis and psoriasis drug Enbrel from China, India, Colombia, Mexico, and Iran fell short of specifications set by Western regulators.
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A new discovery about the effects of aging in our cells could allow doctors to cure or prevent diabetes, fatty liver disease and other metabolic diseases -- and possibly even turn back the clock on aging itself. The new discovery from the lab of Irina M. Bochkis, PhD, of UVA's Department of Pharmacology, shows that the location of our DNA inside the cell's nucleus is critically important. Genes that are turned off are shoved up against the nuclear membrane, which encases the nucleus. But with age, our nuclear membranes become lumpy and irregular, and that prevents genes from turning off appropriately. Learn More

Roche's immunotherapy Tecentriq looks set to become a more competitive option for the treatment of lung cancer, boosted by recent trial results that show the checkpoint inhibitor can help patients live longer when given in combination with older drugs like chemotherapy. The Swiss pharma this week announced a Phase 3 study proved pairing Tecentriq with two chemo agents improved both overall survival and progression-free survival compared to chemo alone in patients. This latest trial is the third Phase 3 trial to show a survival benefit to initial treatment with Tecentriq-based combinations. Learn More

The U.S. FDA has approved BioMarin's drug Palynziq. This comes more than two years after turning in disappointing results from a phase 3 trial of Palynziq to treat the rare inherited blood disorder phenylketonuria (PKU). However, the approval comes with a black box warning on the label, and an estimated average cost of $192,000, a 28% premium to BioMarin's older drug to treat the same condition, Kuvan. Amid this news analysts are already wondering whether the product will be the blockbuster they've long been predicting.
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BioPharma mergers are reducing the number of new medicines coming to market. That's the finding of a new working paper from Yale and London Business School researchers, who determined that 5% more drugs would become available each year if not for what they refer to as "killer acquisitions." The researchers, Yale School of Management's Song Ma and Florian Ederer and LBS's Colleen Cunningham, looked at more than 60,000 drug development projects originated by over 8,000 companies over the past 25 years. Companies are shown to be less likely to continue development of acquired drugs than of in-house projects. Particularly when the acquired product could compete with an in-house effort. Learn More

The U.S. FDA has approved BioMarin's drug Palynziq. This comes more than two years after turning in disappointing results from a phase 3 trial of Palynziq to treat the rare inherited blood disorder phenylketonuria (PKU). However, the approval comes with a black box warning on the label, and an estimated average cost of $192,000, a 28% premium to BioMarin's older drug to treat the same condition, Kuvan. Amid this news analysts are already wondering whether the product will be the blockbuster they've long been predicting.
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AveXis, recently acquired by Novartis for $8.7 billion, will invest $55 million to build a new manufacturing facility in Durham, North Carolina. The facility will create 200 jobs and offer employees a significantly competitive salary. AveXis will use the new site to make its first product candidate, AVXS-101, a gene therapy to treat three types of spinal muscular atrophy (SMA). Durham was competing with the state of Illinois for the site. Illinois approved tax credits of almost $8 million to bring the jobs to Libertyville, Illinois. But instead, AveXis took a $3 million incentive package in North Carolina.
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This paper describes a new pH-responsive peptide tag that adds a protein reversible precipitation and redissolution character. This peptide tag is a part of a cell surface protein B (CspB) derived from Corynebacterium glutamicum.
Proinsulin that genetically fused with a peptide of N-terminal 6, 17, 50, or 250 amino acid residues of CspB showed that the reversible precipitation and redissolution depended on the pH. The transition occurred within a physiological and narrow pH range. A CspB50 tag comprising 50 amino acid residues of N-terminal CspB was further evaluated as a representative using other pharmaceutical proteins... Learn More

Novartis has announced that its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab). Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis according to Novartis. Zessly is the sixth approved biosimilar medicine for Sandoz, with several more major oncology and immunology launches expected globally by 2020. Learn More

Astellas has begun restructuring its operations, with plans to discontinue all work at Astellas Research Technologies, its R&D subsidiary of about 200 employees, by March 31, 2019. The company is offering an early retirement incentive program that it estimates will eliminate 600 staff positions altogether. This comes amid the loss of exclusivity in major products that is expected to cause a drop in 2019 operating profits. Additionally, Astellas' CMC and analysis laboratories will be sold off to the contract research organization Eurofins Pharma Services. The sale will give Eurofins a strong laboratory presence in Japan. Learn More

The U.S. House of Representatives this week passed a Senate-passed version of a bill, known as "Right-to-Try," and President Donald Trump has indicated he will sign it. The House's passage of the Senate bill from last August, after a previous House bill passed but was not taken up by the Senate, and after a previous House version failed to pass, also follows the Right-to-Try movement's spread across state legislatures. President Donald Trump has said he would sign the bill and Vice President Mike Pence said it was a priority for him. Learn More

WuXi Biologics has announced that it will invest $60 to establish a state-of-the-art biologics manufacturing facility in Singapore. This state-of-the-art "facility of the future" will be built upon the novel approach WuXi Biologics has pioneered deploying single-use bioreactors. It is also designed to be able to run continuous bioprocessing, a next-generation manufacturing technology to be first implemented in Asia outside of China. A total of approximately 4,500 L bioreactor capacity will be installed with two 2,000 L traditional fed-batch and one 500 L perfusion based continuous processing. An early-stage bioprocess development lab will also be included. Learn More

The U.S. FDA this week finalized a guidance revised in 2013 to help companies validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies that require pharmacokinetic, toxicokinetic or biomarker concentration evaluation. The differences between the draft and final guidance, which is 10 pages longer, include a re-working of the text, a new title for Section III, which was previously named "Chromatographic methods" but is now "Bioanalytical method development and validation," and new sections on parameters of chromatographic assays (CCs) and ligand binding assays (LBAs). Learn More

Scientists know that faulty proteins can cause harmful deposits or "aggregates" in neurological disorders such as Alzheimer's and Parkinson's disease. Although the causes of these protein deposits remain a mystery, it is known that abnormal aggregates can result when cells fail to transmit proper genetic information to proteins. University of California San Diego Professor Susan Ackerman and her colleagues first highlighted this cause of brain disease more than 10 years ago. Now, probing deeper into this research, she and colleagues have identified a gene, Ankrd16, that prevents the protein aggregates they originally observed.
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The U.S. FDA has warned oncologists and clinical trial investigators of early signs from two trials that some bladder cancer patients treated first with either Merck & Co.'s Keytruda or Roche's Tecentriq alone were dying sooner than those given platinum-based chemotherapy. Reviews by data monitoring committees overseeing Merck's KEYNOTE-361 and Roche's IMvigor130 observed decreased survival in the monotherapy arm of each study among patients whose tumors expressed low levels of PD-L1, a biomarker associated with response to immunotherapy. Learn More

The FDA has announced the approval of Amgen's migraine drug Aimovig. This drug, the first FDA approved migraine prevention drug for use in adult populations, falls under a "new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks," according to an FDA announcement. During the process of reviewing the drug the FDA evaluated results from three clinical trials involving more than 3,000 patients suffering from chronic or episodic migraines. The most commonly reported adverse reactions being injection site reactions and constipation says Amgen. Learn More

Johnson and Johnson says it will stop mid-stage trials testing its experimental Alzheimer's drug after observing safety issues, the latest drugmaker to abandon developing treatments for the memory-robbing disease. Some trial participants showed serious elevations of liver enzymes and the company concluded that the benefit-risk ratio offered by the drug, atabecestat, no longer supported its development, said Janssen, a unit of Johnson and Johnson. Atabecestat belongs to a class of experimental Alzheimer's drugs called BACE inhibitors that block an enzyme involved in the production of a protein that creates brain plaques, which are considered a major cause for the disease. Learn More

The U.S. FDA is reversing a decision to award a no-bid $4.2 million grant to a policy center at Duke University headed by former FDA commissioner and current paid board member for Johnson & Johnson Mark McClellan. The funding opportunity was posted in late April as a five-year grant for which only a single institution, the Duke-Robert J. Margolis Center for Health Policy, was eligible to apply. The grant's purpose was to "to help advance regulatory science to promote the increased availability of safe and effective drugs to the public," according to the request for application. The FDA now says that it is in the process of opening the grant application to other institutions. Learn More

Single-use (SU) technologies and continuous bioprocessing have attracted attention as potential facilitators of cost-optimized manufacturing for monoclonal antibodies. While disposable bioprocessing has been adopted at many scales of manufacturing, continuous bioprocessing has yet to reach the same level of implementation. In this study, the cost of goods of Pall Life Science's integrated, continuous bioprocessing (ICB) platform is modeled, along with that of purification processes in stainless-steel and SU batch formats. All three models include costs associated with downstream processing only. Evaluation of the models across a broad range of clinical and commercial scenarios reveal that the cost savings gained by switching from stainless-steel to SU batch processing are often amplified by continuous operation. Learn More

Biochemists have determined the detailed structure of a volume-regulated chloride channel. This cellular valve is activated in response to swelling to prevent the cell from bursting. The protein also plays an important role in the uptake of chemotherapeutics and the release of neurotransmitters after a stroke. The controlled regulation of its activity thus opens up a promising strategy for novel therapies. The study findings are published in this months issue of the journal Nature. Learn More

Tufts University and BioLabs have announced the opening of a full-service biotech facility supporting high-potential, early-stage life sciences startup ventures in the Boston area. The day to day operations of the site will be managed by the latter. The 15,000-square-foot facility, on the 14th floor of a historic Art Deco building, features 50 ready-to-use lab benches, private lab suites for companies with up to 10 scientists, private and coworking offices, and event space. It is outfitted with state-of-the art equipment and provides resident companies with access to Tufts' core facilities and services on a cost-effective, fee-for-service basis. Learn More

A new open-access white paper discusses the practical aspects of attribute selection and ranking, a critical first step in biosimilar drug development. These updated analytical standards were compiled by an international, team involving the FDA and biopharma industry experts, and The American Association of Pharmaceutical Scientists (AAPS), which published the paper this week in The AAPS Journal. The paper, entitled "Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars," includes case examples and a list of commonly used analytical methods to illustrate current practices. Learn More

The biopharma sector in Massachusetts is growing so fast that companies are struggling to fill vacancies. Jobs that require associate's degrees, such as lab technicians, and those that require doctorates, such as scientific researchers, are among the hardest to fill, according to a new study. Nearly 12,000 new jobs are expected to be created between mid-2017 and mid-2023, an increase of more than 17 percent. However, the number of students graduating with a biotech-related associate's degree rose 56 percent since 2010, but job openings requiring that degree grew by more than 100 percent. Similarly, the number of students graduating with a biotech-related PhD rose 16 percent, but job openings requiring that degree grew 43 percent. Learn More

Single-use (SU) technologies and continuous bioprocessing have attracted attention as potential facilitators of cost-optimized manufacturing for monoclonal antibodies. While disposable bioprocessing has been adopted at many scales of manufacturing, continuous bioprocessing has yet to reach the same level of implementation. In this study, the cost of goods of Pall Life Science's integrated, continuous bioprocessing (ICB) platform is modeled, along with that of purification processes in stainless-steel and SU batch formats. All three models include costs associated with downstream processing only. Evaluation of the models across a broad range of clinical and commercial scenarios reveal that the cost savings gained by switching from stainless-steel to SU batch processing are often amplified by continuous operation.


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Recombinant proteins are revolutionizing present day therapeutics. They are generally expressed as insoluble inclusion bodies in the E. coli and mis-folding, loss of protein, high cost of down streaming are the hurdles in their recovery. For the first time, we are reporting the refolding with simultaneous purification of rhASP in E. coli using a single step utilizing Protein Folding - strong anion exchange chromatography (PF-SAX). The purification method is also standardized for optimal concentration of solution additives, pH and mobile phase composition. The results showed purification of rhASP with anion exchange chromatography was effective.


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The U.S. FDA launched a website today designed to put branded drug manufacturers on notice if they block generic competition as part of President Donald Trump's plan to tackle high drug prices, Commissioner Scott Gottlieb said this week. The site, to be updated on a continuous basis, aims to curb the practice of branded manufacturers limiting access to samples generic drugmakers need to develop copies. The FDA received more than 150 letters from generic drugmakers about difficulties accessing product samples from brand manufacturers, according to HHS Secretary Alex Azar. Learn More

Irish engineering and construction management firm DPS has won a major contract from the global pharmaceutical company AstraZeneca. DPS is to provide engineering, procurement, construction management, and validation (EPCMV) services for small and medium-sized projects on AstraZeneca's pharmaceutical site in Södertälje, Sweden. The contract win means that DPS will now establish a new office in Sweden to service AstraZeneca initially, as well as other clients in the Nordic region at a later stage. The value of the contract has not been disclosed, but it is expected that over 100 DPS engineering personnel potentially will be working on AstraZeneca projects, depending on capital expenditure levels. Learn More

A report from the Centre for Innovation in Regulatory Science (CIRS) released this month finds that the U.S. FDA has reclaimed its position as the fastest major regulator for approving new drugs and biologics. According to the report, the FDA spent a median 243 days to approve products with a new active substance (NAS) in 2017, 90 days faster than its closest peer, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), which took a median 333 days. While the FDA has typically taken less time to approve NASs than other prominent regulators over the last decade, efforts by Japan to speed drug evaluations led PMDA to edge FDA out for quickest reviews from 2014-2016. Learn More

The U.S. FDA this week approved the first biosimilar to Amgen's blockbuster Epogen/Procrit. Bringing the total number of biosimilars approved by the regulatory agency to Ten. The biosimilar, called Retacrit, will be marketed by Pfizer's Hospira unit and is approved for the same indications as Epogen/Procrit, including the treatment of anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with an HIV infection, and for utilization before and after surgery to reduce the need for red blood cell transfusions. The approval comes after the FDA originally rejected Pfizer's application for Retacrit in June 2017. Learn More

The U.S. FDA has issued a warning letter to CMO Ei LLC after an inspection of the company's Kannapolis, North Carolina site found that the company manufactured topical drugs and pesticides using the same equipment in the same building. "It is unacceptable as a matter of cGMP to continue manufacturing drugs using the same equipment that you use to manufacture pesticides or other non-pharmaceutical products due to the risk of cross-contamination," the FDA wrote. The FDA also noted that the company did not adequately validate its cleaning procedures to ensure against cross-contamination between different drugs manufactured using the same equipment. Learn More

Gilead has leased roughly 120,000 sq. ft. in the Netherlands to support the manufacturing of its cancer cell therapy Yescarta. A therapy that is currently awaiting a decision on approval by EU regulators. Gilead expects the facility, which is located in an industrial park just across the highway from the Schiphol Airport in Amsterdam, to be operational on or before 2020. Yescarta, which Alert readers will recall Gilead acquired in its $11.9 billion purchase of Kite Pharma, is a CAR-T therapy and as such requires that the extraction, genetic engineering and subsequent reinfusion of immune cells into cancer patients occurs within a short window of time. Learn More

Lilly is bringing a cancer drug it sold off a couple of years ago back in-house with its announcement this week of the acquisition of AurKa Pharma for $110 million upfront and $465 million tied to milestones. In doing so, Lilly gains renewed access to AK-01, a first-in-class Aurora kinase A inhibitor in early-stage testing for a variety of solid tumor types. According to the terms of the deal, the $110 million upfront provides Lilly with ownership of all AurKa Pharma shares. With the additional $465 million coupled to the achievement of specific regulatory and sales milestones. Learn More

ATyr has announced an immediate workforce reduction of roughly 30% and termination of IND-enabling activities, including GMP manufacturing, for the panel of antibodies identified in its ORCA program. This comes as pre-clinical data generated over the last month did not show sufficient efficacy to justify further development at this time. Instead, the company will focus its remaining resources on the development of ATYR1923. While no formal comments have been made as to its plans beyond the near term, a quick look at the company's burn rate and most recent cash on hand seem to indicate an ability to continue forward with its development efforts for the foreseeable future. Learn More

There is a program in Cambridge, Massachusetts that should be viewed as a 'must -have' for other biotech hubs. Just-A-Start launched a biomedical careers training program 26 years ago, partnering with Bunker Hill Community College and local employers like Biogen and Novartis. The program provides an intensive overview of science courses and laboratory experience and meets current industry needs. In addition to biology, chemistry, biotechnology and digital literacy courses, students also spend time in the lab. A 2016 evaluation by the Center for Social Policy at UMass Boston said that almost 80 percent of graduates got a well-paying job in the industry. Learn More

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has announced that it has adopted new guidance on good manufacturing practice (GMP) inspections, outlining a process for "desk-top assessment" of overseas facilities to identify instances when an acceptable level of GMP compliance can be confirmed and assured without on-site inspections. Based on a draft from the International Coalition of Medicines Regulatory Authorities (ICMRA), PIC/S said the guidance provides a tool and framework aiming to help competent authorities (CAs) prioritize resources for GMP inspections for human and veterinary medicines. Learn More

President Donald Trump's long-promised plan to bring down drug prices would mostly spare the biopharma industry he previously accused of "getting away with murder." Instead, he focuses on private competition and more openness to reduce America's prescription pain. In Rose Garden remarks at the White House late last week, Trump called his plan the "most sweeping action in history to lower the price of prescription drugs for the American people." But it does not include his campaign pledge to use the massive buying power of the government's Medicare program to directly negotiate lower prices for seniors. That idea has long been supported by Democrats but is a non-starter for drugmakers and most Republicans in Congress. Learn More