BioPharm International, November 2010 Issue (PDF)
Making Chemically Defined Media Work
Time to Revisit Supplier Quality Management
Best practices to strengthen supplier quality management.
Biosimilars Regulation in the US: The Challenges
The pathway for biosimilar approval in the US has been set. But are US patients too far behind Europe?
Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks
Adequate characterization of materials protects product quality.
Systematic Approaches to Develop Chemically Defined Cell Culture Feed Media
Making chemically defined media work.
High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
These new analytical methods can reduce analysis and product development time.
Biotech Manufacturers Anticipate CER Challenges
Comparative effectiveness poses challenges for drug manufacturers.
A Dizzying Course
China's regulators acknowledge the quality gap, and have a plan for steady improvement.
