BioPharm International, September 2010 - BioPharm International

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BioPharm International, September 2010
Features
Label-Free and Labeled Technology for Protein Characterization and Quantitation
By Daniele Gerion , Gwo-Jen Day
Use it label-free, or add labels to detect contaminants in solution.
Biosimilars Approvals in the US: The Path Forward
By John M. Engel
An in-depth analysis of the patent provisions of the new legislation.
Design Space Development for Lyophilization Using DOE and Process Modeling
By Jagannathan Sundaram , Chung C. Hsu , Yun-Hua Max Shay , Samir U. Sane
Develop a relevant design space without full factorial DoE.
Regulatory Beat
REMS Program Challenges Manufacturers, Providers
By Jill Wechsler
Too many REMS cause headaches for doctors and the industry.
From the Editor
Biosimilars, Part 3: Interchangeability
By Laura Bush
The third holy grail of biosimilars: interchangeability.
Compliance Notes
Quality Management Systems for Small Biopharmaceutical Organizations
By Graham Clapperton , Michael Gamlen
What small biotechs need to know about quality management systems.
Perspectives on Outsourcing
Build Versus Buy in the Current Biotech Market Environment
By Maria Lusk
How current economic conditions affect your build-or-buy decision.

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