CASSS, the International Separation Science Society, in collaboration with BioProcess International, the industry’s leading
biopharmaceutical publication, is proud to present The CMC Strategy Forums – Celebrating A Decade of Collaborative Technical and
Regulatory Interaction.
Divided into five chapters, and presented as Special Reports in 2015, each chapter is a compilation of
peer-reviewed articles originally published in BioProcess International based upon the outcomes of CMC Forum meetings from 2003-2013.
QbD and Manufacturing Strategies
This e-Book, is Chapter Two of the series, and covers
- Multiproduct Facility Design and Control for Biologics: Challenges and Considerations
- Drug Products for Biological Medicines: Novel Delivery Devices
- Challenging Formulations, and Combination Products
- New Paradigms for Process Validation: A Practical Approach
- Biosimilar Products: Scientific Principles, Challenges, and Opportunities
Posted by Tim Sandle
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