BioPharm International, November 2010 - BioPharm International

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BioPharm International, November 2010
Features
Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks
By Anurag S. Rathore, PhD , Duncan Low
Adequate characterization of materials protects product quality.
High-Throughput Multi-Product Liquid Chromatography for Characterization of MAbs
By Jennifer C. Rea, PhD , G. Tony Moreno , Yun Lou , Rahul Parikh , Dell Farnan, PhD
These new analytical methods can reduce analysis and product development time.
Systematic Approaches to Develop Chemically Defined Cell Culture Feed Media
By Efren Pacis , Natarajan Vijayasankaran , Jincai Li , Martin Gawlitzek , Ashraf Amanullah , Feng Li
Making chemically defined media work.
Regulatory Beat
Biotech Manufacturers Anticipate CER Challenges
By Jill Wechsler
Comparative effectiveness poses challenges for drug manufacturers.
Time to Revisit Supplier Quality Management
By James R. Darnell, Jr.
Best practices to strengthen supplier quality management.
From the Editor
A Dizzying Course
By Laura Bush
China's regulators acknowledge the quality gap, and have a plan for steady improvement.
Final Word
Biosimilars Regulation in the US: The Challenges
By Philip Ridley-Smith
The pathway for biosimilar approval in the US has been set. But are US patients too far behind Europe?

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