Search results for " WCBP"
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Modern Manufacturing Key to More Effective Vaccines
FDA is applying lessons learned from Ebola to streamline vaccine development, noted Philip Krause, deputy director of CBER’s Office of Vaccine Research & Review (OVRR), at the January 2018 WCBP sympos…
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Are You in Control of the Quality of Your mAbs?
Better biotherapeutic characterization for improved quality control
At the recent WCBP conference in Washington, D.C., Dr. Stuart Knowling from Antibody Analytics presented how the latest innovati…
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N-Glycan Analysis of Biotherapeutic Proteins
Jones, “N-Glycan Analysis using InstantDye Workflows for the Screening & Characterization of Biotherapuetics,” presentation at the WCBP Conference (Washington, DC, 2017).
32. R. Upton et al., …
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Vaccine Development and Production Challenges Manufacturers
Pfizer reported at the January 2015 CASSS-sponsored WCBP symposium in Washington, D.C. that its development program for its meningococcal serogroup B vaccine benefited from the application of “an exte…
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Bioburden Control in the Biopharmaceutical Industry
Hughes, “Aseptic Processing of Biological Products: Current Regulatory Issues,” presentation at the WCBP 2016 Symposium (Washington, DC, 2016).
4. CFR Title 21, 210.1-3, 211.4-31.
5. FDA, …
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Modern Manufacturing Systems Key to FDA Quality Initiative
The change should help OBP manage its workload more effectively as biotech product development continues to expand, OBP chief Steve Kozlowski explained at the January 2015 WCBP symposium in Washington…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Kozlowski, “Implementation Activities for QbD: FDA Office of Biotechnology Products,” presentation at 2010 WCBP CMC Strategy Forum (Bethesda, MD, 2010).
11. L. Zang, X. L. Hronowski, Y. Lyubarskay…
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Manufacturers Struggle with Breakthrough Drug Development
Evaluating these very novel therapies requires “a great deal of attention,” she observed at the WCBP symposium sponsored by CASSS in Washington, DC in late January 2014. Demonstrating efficacy is not …