Search results for "Blood" in Articles / App Notes
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
The New World of Biopharmaceutical Manufacturing
…Langer (BioPlan Associates): Over the past 40 years, single-use systems have moved from simple blood and intravenous bags to simple media and serum containers, and to highly engineered, complex devic…
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Unifying Continuous Biomanufacturing Operations
While the Bayer patent only demonstrated the efficacy of an integrated biomanufacturing train for the production of recombinant blood coagulation Factor VIII, the authors of the patent argued “the inv…
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Ensuring the Biological Integrity of Raw Materials
In 2010, Eric Delwart, PhD, researcher and adjunct professor of laboratory medicine in the Blood Systems Research Institute at the University of California San Francisco, tested eight viral vaccines u…
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Improving Process-Scale Chromatography
… chromatography resins that address challenges in the purification of mAbs, antibody fragments, and blood factors, as well as viral vaccine and gene-therapy vectors, according to Paul Lynch, senior p…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
…ousands of 100% animal-sourced compounds continuously perfused by a pulsing stream of nutrient-rich blood serum. The efforts behind these achievements were driven not only by the opportunity to under…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Examples include: whole blood, serum, cells, tissue extracts, and intestinal mucosa. Processed primary animal origin materials are derived after a series of processing steps such as extraction, precip…
Article
Vaccine Development Faces Urgency and Challenges
FDA would get $10 million to support oversight of vaccines and diagnostics, as well as assays to screen blood for the Zika virus. Additional resources would help the US Department of Health and Human …
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Innovative Therapies Require Modern Manufacturing Systems
FDA’s Center for Biologics Evaluation and Research (CBER) also approved more than a dozen new biologics, vaccines, blood products, and diagnostics.
In the process, FDA met nearly all the review ti…
Article
Framing Biopharma Success in 2016
The Center for Biologics Evaluation and Research (CBER) approved more than a dozen new biologics, vaccines, blood products, and diagnostics. These numbers, and types of drugs approved, indicate that t…