BioPharm International, July 2009 (PDF)
An Effective Way to Ensure Consistent Protein Expression
How to Shift from Reactive Compliance to Strategic Quality Management
A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.
Site-Directed Engineering of Defined Chromosomal Sites for Recombinant Protein and Virus Expression
Method for integration of transgenes.
Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress
The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.
Biotech Shows Glimmer of an Upward Trend
Although the markets closed on a positive note in May, it will still take many more months before biotech starts on the road to full recovery.
Facing Down the Enemy
The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.
Use of Contract Analytical Laboratories: A Pfizer Global Biologics Perspective
By following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing
High-Cell-Density Culture to Produce Plasmid DNA for Gene Therapy in E. coli
How to produce Plasmid DNA in a high-cell-density culture.
Ensuring Product Quality and Managing Risk: Validate, Verify, Implement
Biopharmaceutical companies must follow an active approach to managing their supply chains.
Extended Risk Management Proposals Challenge Manufacturers
The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agents.