BioPharm International, September 2009 - BioPharm International

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BioPharm International, September 2009
Cover
The Proper Use of 47-mm Flat Disc Filters in Filter Sizing Studies
By Maik W. Jornitz , Theodore H. Meltzer , Wayne Garafola
Why staining is crucial in flow decay studies.
Features
Comparison of Camelid Antibody Ligand to Protein A for Monoclonal Antibody Purification
By Jia Liu, PhD , Aaron Cheung , John L. Hickey , Sanchayita Ghose, PhD
A stable alternative to Protein A chromatography.
Quality Risk Management Demystified at CMC Strategy Forum
By Laura Bush
ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.
Manufacturing Economics Series
Breaking the Rapid Microbiological Method Financial Barrier: A Case Study in Return on Investment and Economic Justification
By Michael J. Miller, PhD
A case study implementing rapid microbiological methods.
From the Editor
A True Assessment of Risk
By Laura Bush
If risk assessments only identify "the usual suspects," the process will not add much value.
Regulatory Beat
Biopharmaceutical Manufacturers Seize Opportunities in the Global Health Arena
By Jill Wechsler
The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.
Perspectives on Outsourcing
Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing
By K. Fritchman , J. Kuchibhatla , Yann Pouliquen , J. Brooks , S. Holdread , A. Imam , C. Velnoskey , V. Weinknecht
To select the right partner for media design and optimization services, several key factors must be considered.
Final Word
Patenting Biotechnology Inventions Will Become More Challenging
By Astrid R. Spain
Recent patent rulings raise significant patentability questions for DNA sequence inventions.

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