BioPharm International, December 2009

Cover

Quality by Design for Biotechnology Products—Part 2

By Taruna Arora , Roger Greene , Jennifer Mercer , Paul Tsang , Meg Casais , Stuart Feldman , Jutta Look , Tony Lubiniecki , Joseph Mezzatesta , Stefanie Pluschkell , Mark Rosolowsky , Anurag S. Rathore, PhD , Mark Schenerman , Tim Schofield , Samantha Sheridan , Paul Smock , Sally Anliker , Bernerd McGarvey , Bruce Meiklejohn , Jim Precup

Second in a three-part series that discusses the complexities of QbD implementation in biotech development.

Features

Freeze-Thaw Performance and Robustness Assessment of Celsius FFT 6L

By Nicolas Voute

A case study assesses freezing time and physical robustness under stress.

Manufacturing Economics Series

The Impact of Disposables on Project Economics in a New Antibody Plant: A Case Study

By José M. País-Chanfrau , Katia Zorrilla , Ernesto Chico

A case study compares capital costs, operating expenses, and NPV for a new MAb plant.

Regulatory Beat

The Promise and Perils of Vaccines

By Jill Wechsler

Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.

Disposables Advisor

Disposables in Rapid Response Manufacturing: The Next Steps

By Andrew Sinclair , Miriam Monge

Suppliers, manufacturers, and governments must work together to plan how best to develop and deploy disposable systems for emergency response.

Outsourcing Insights

CDMOs Benefit from the Growing Biologics Market

By Jim Miller

A new analysis highlights growth opportunities and challenges for contract development and manufacturing organizations.

Final Word

Faking It

Drug counterfeiting has become a major problem for the FDA today; a variety of solutions is needed.

From the Editor

Speeding Up Slowly

By Laura Bush

Do we really have to choose between saving money and saving time?

Expression Systems

Licensing of Expression Systems

By Eric S. Langer

Gaining a license can be a complex process, but a few key tips can help you avoid common pitfalls and patent infringements.