Friday 25 September 2015

QbD and Manufacturing Strategies

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
For details see: BioProcess International

Posted by Tim Sandle

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