BioPharm International, February 2008 - BioPharm International

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BioPharm International, February 2008
Features
Extractables and Leachables Study Approach for Disposable Materials Used in Bioprocessing
By Xiaochun Yu , Derek Wood , Xiaoya Ding, PhD
Two case studies illustrate a systematic approach.
Cleaning Validation for Biopharm Manufacturing at Genentech, Part 1
By A. Hamid Mollah, PhD
Best practices from Big Biotech, including how to handle new product introductions.
How to Avoid Becoming a Biotech Zombie Part 2
By Carmen Medina
Putting business principles to work in biotechs requires careful implementation of nine critical business systems.
Columns and Departments
Presenting Data Effectively
By Steven Walfish
The key to a good graphical presentation is to select the method that best fits the data.
The Disposables Revolution
By Andrew Sinclair
The use of disposables has changed significantly in the biopharmaceutical industry.
Inspections in a Global Industry
By Laura Bush
In our increasingly global industry; foreign manufacturing inspections are more important than ever.
Indian Biogenerics: An Evolving Industry
By Eric S. Langer
Indian biogenerics could form a major piece of the global biotherapeutics market in the future.
The Role of Analytical Science in the Debate over Biosimilars
By Jeffrey R. Mazzeo
Both innovator and generics companies are using analytics to support comparability arguments.
Limited Resources Challenge Regulators
By Jill Wechsler
The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls.

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