BioPharm International, July 2009 - BioPharm International

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BioPharm International, July 2009
Cover
Site-Directed Engineering of Defined Chromosomal Sites for Recombinant Protein and Virus Expression
By D. Wirth, PhD , L. Gama-Norton , R. Schucht, PhD , K. Nehlsen, PhD
Method for integration of transgenes.
Features
High-Cell-Density Culture to Produce Plasmid DNA for Gene Therapy in E. coli
By Odalys Ruiz Hernández , Mariela Pérez de la Iglesia , Martha Pupo , Miladys Limonta Fernández , Dinorah Torres Idahody, PhD , Saily Martínez Gómez , Karelia Macias Cosme , Yanay Proenza Jimenez , Jorge Valdes Hernández , Eduardo Martínez, PhD
How to produce Plasmid DNA in a high-cell-density culture.
Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress
By Brian J. Del Buono, PhD
The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.
From the Editor
Facing Down the Enemy
By Laura Bush
The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.
Regulatory Beat
Extended Risk Management Proposals Challenge Manufacturers
By Jill Wechsler
The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agents.
Perspectives on Outsourcing
Use of Contract Analytical Laboratories: A Pfizer Global Biologics Perspective
By John Ruesch , Amy St. Charles
By following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing
Compliance Notes
How to Shift from Reactive Compliance to Strategic Quality Management
By Michael M. Breggar
A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.
Burrill on Biotech
Biotech Shows Glimmer of an Upward Trend
By G. Steven Burrill
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.
Final Word
Ensuring Product Quality and Managing Risk: Validate, Verify, Implement
By Ellen Leinfuss
Biopharmaceutical companies must follow an active approach to managing their supply chains.

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