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