BioPharm International, December 2009 - BioPharm International

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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.

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