Quality by design for biotechnology products—part 1
December 29, 2013 - BioPharm International
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Fe
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Comparing Protein A Resins for Monoclonal Antibody Purification
December 16, 2013 - By: Shohei Kobayashi, Yasufumi Ueda BioPharm International
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
ReadyToProcess WAVE 25 Bioreactor System
December 9, 2013 - Cytiva
The single-use ReadyToProcess WAVE 25 bioreactor system is a reliable and intuitive cell culture device for working volumes up to 25 L.
The system is
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Bioprocessing Advances in Vaccine Manufacture
December 6, 2013 - Eric S. Langer, Ronald A. Rader BioPharm International
The vaccine ind
Supplier-Change Management for Drug-Product Manufacturers
November 22, 2013 - By: S. Jones, B. Trdina, C. Pullinger, K. Vermeulen, E. Flamm, A. Keusch, J. Goetz for BioPharm Inte
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating
Evolution of the Monoclonal Antibody Purification Platform
Monoclonal
November 22, 2013 - By: Anurag S. Rathore, Ranga Godavarti, Vijesh Kumar, Nihal Tugcu for BioPharm International
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Trends in Downstream Bioprocessing
November 1, 2013 - Eric Langer BioPharm International
Downstream processing involves the
State of Quality and Compliance in the Biopharmaceutical Industry
The late 1990s and earl
October 23, 2013 - Anastasia G. Lolas, Ian Uydess BioPharm International Magazine
Have FDA initiatives improved manufacturing quality?
FDA Seeks Metrics to Define Drug Quality
October 18, 2013 - Jill Wechsler, BioPharm International
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical dru
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Navigating Emerging Markets: Middle East and North Africa
October 13, 2013 - Jill E. Sackman, PhD , BioPharm International Magazine
The pharmaceutical industry grows despite conflict in the Middle East.
