Search results for " cell"
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FDA Approves First Biosimilar
Amgen is suing Sandoz for patent infringement (covering a method of using filgrastim to treat a disease requiring peripheral stem cell transplantation), unfair competition, and conversion, and tried t…
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Quality by Design and Extractable and Leachable Testing
Impact on cell culture might also be important, particularly for single-use fermentation bags, for example, and USP Biological Evaluation, In Vitro (3) would be a reasonable minimal CQA for which to …
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Setting Standards for Biotech Therapeutics in India
Many new general chapters pertaining to topics such as therapeutic monoclonal antibodies, host cell proteins and DNA, and viral safety are in the works for the next IP edition.
As mentioned previo…
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Continued Process Verification for Biopharma Manufacturing
Its recommendations are based on a typical cell culture production process for making a fictitious monoclonal antibody (mAb) product (3). Although this model plan does not provide examples of all aspe…
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Pharma Investments Reflect Key Industry Trends
According to the company, it now has a more focused portfolio with depth in dermatology, heart failure, respiratory, cell therapy, and oncology in its pharmaceuticals business, a strong position in ey…
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Concentration and Diafiltration of Cell-Derived, Live Influenza Virus Using 750 C Hollow Fiber Filter Cartridge
Cross flow filtration (CFF) is a technique extensively used in vaccine production and particularly in influenza vaccine manufacturing. In contrast to normal flow (dead-end) filtration (NFF), the fee…
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Single-Use and Continuous Processing Technologies Change Facility Design
With no waiting for cell growth and cell-culture bioreactors continuously operating, columns can be smaller than when they need to handle whole fermenter volumes at one time. Ultimately, the whole fac…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Otherwise, cell culture, purification, and drug product development may put undue importance on meeting certain criteria that are ultimately not critical, resulting in suboptimal processes that make u…
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
But with continuous processing, once the protein is secreted from the cells it can be taken out of the bioreactor and purified immediately, so there’s no degradation.
Up until a few years ag…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The European Medicines Agency (EMA) approved the first mAb biosimilar developed by Celltrion and Hospira in 2013 (infliximab: Remsima/Inflectra). Development of clear, regulatory approval pathways for…