Milestones and Moderate Progress in 2012 Drug Approvals
May 28, 2013 - Gary Walsh, PhD, BioPharm International
First gene therapy and plant-based expression vector products approved in 2012.
Advancing QbD in the EU
May 20, 2013 - Sean Milmo, BioPharm International
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) an
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The Lifecycle Change of Process Validation and Analytical Testing
April 8, 2013 - BioPharm International
The Future of Biopharma
March 18, 2013 - BioPharm Internationa
What the industry's future holds and what needs to be done to get there.
Automated Concentration and Diafiltration of Multiple siRNA Sampl
March 4, 2013 - BioPharm International
A Look Ahead at BioPharma Manufacturing and Regulation
February 11, 2013 - BioPharm International
The FDA talks about the changing scope of regulatory science.
PDA's Technical Report for Biotech Cleaning Validation
January 14, 2013 - BioPharm International
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning val
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Challenges for biosimilar developers: A conversation with Dr. How
January 14, 2013 - BioPharm International
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulato
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