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.