Search results for " biologic" in Articles / App Notes
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
…control could stymie advancement in this field, cautions Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER). It’s “not simple” to bring a clinical production process t…
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Challenges in Cell Harvesting Prompt Enhancements
Challenges in Cell Harvesting Prompt Enhancements
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
By Feliza Mi…
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Putting Viral Clearance Capabilities to the Test
“This analysis is relatively simple for biologicals produced in well-characterized cells in culture but can be much more complex for products derived from uncharacterized cells or from animal material…
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Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
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FDA Framework Spurs Advanced Therapies
This program is designed to expedite the development and review of regenerative medicine advanced therapies and is managed by FDA’s Center for Biologics Evaluation and Research (CBER). Applicants that…
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3rd BioProcessing Asia Preview: Q&A with John Curling
Attendees will leave with new knowledge and ideas that will contribute to improved biological products serving the Asian communities.
What news would you like to highlight regarding the rece…
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Bioburden Entry Points in Downstream Processing
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips in this blog.
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Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
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Prepare for an FDA Bioburden Inspection
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.
Read blog here
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Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
Bioburden control is an area of serious concern for anyone making mAbs or other biologicals. Manufacturers’ efforts to avoid microbial contamination are today being complemented by development…