Search results for " productivity" in Articles / App Notes
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…
Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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Article
The Development and Application of a Monoclonal Antibody Purification Platform
Recent advances in mammalian cell culture technology have resulted in significant increases in upstream productivity, with antibody titers of >5 g/L becoming increasingly common. Such increases could …
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
…tion add value and time savings to the overall characterization process, which will enable increased productivity and faster product development.
Monoclonal antibodies (MAbs) are an importa…
Article
A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
nobeastsofierce/Shutterstock.com
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Article
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 …
Article
Platform Technologies Improve Protein Expression
Primary drivers to the development of a new therapeutic protein platform are the desire to improve efficiency and productivity, the need to increase the agility of manufacturing, and the fact that com…
Article
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…