BioPharm International, September 2009 Issue (PDF)
Essential Steps to Ensure Accurate Filter Scale-up
A True Assessment of Risk
If risk assessments only identify "the usual suspects," the process will not add much value.
Comparison of Camelid Antibody Ligand to Protein A for Monoclonal Antibody Purification
A stable alternative to Protein A chromatography.
Breaking the Rapid Microbiological Method Financial Barrier: A Case Study in Return on Investment and Economic Justification
A case study implementing rapid microbiological methods.
Patenting Biotechnology Inventions Will Become More Challenging
Recent patent rulings raise significant patentability questions for DNA sequence inventions.
The Proper Use of 47-mm Flat Disc Filters in Filter Sizing Studies
Why staining is crucial in flow decay studies.
Biopharmaceutical Manufacturers Seize Opportunities in the Global Health Arena
The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.
Quality Risk Management Demystified at CMC Strategy Forum
ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.
Strategic Outsourcing of Media Design and Cell Culture Media Manufacturing
To select the right partner for media design and optimization services, several key factors must be considered.