Extractables and Leachables Study Approach for Disposable Materials Used in Bioprocessing
Two case studies illustrate a systematic approach.
Limited Resources Challenge Regulators
The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls.
The Disposables Revolution
The use of disposables has changed significantly in the biopharmaceutical industry.
The Role of Analytical Science in the Debate over Biosimilars
Both innovator and generics companies are using analytics to support comparability arguments.
Inspections in a Global Industry
In our increasingly global industry; foreign manufacturing inspections are more important than ever.
Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 1
Best practices from Big Biotech, including how to handle new product introductions.
Presenting Data Effectively
The key to a good graphical presentation is to select the method that best fits the data.
Indian Biogenerics: An Evolving Industry
Indian biogenerics could form a major piece of the global biotherapeutics market in the future.
How to Avoid Becoming a Biotech Zombie Part 2
Putting business principles to work in biotechs requires careful implementation of nine critical business systems.
