Bioprocessing Summit

Date: 15 - 19 Aug 2016 Location: Westin Boston Waterfront City: Boston Country: USA Visit the event website for more information

Booth No. 508


Thursday, August 18, 2016 - 9:30 am


Analytical Challenges and Control Strategies for High Concentration Formulations and Associated Delivery Devices

Abbas Razvi, Ph.D., Sr. Principal Scientist & Group Leader, Formulation Development



Biological drug products are complex systems comprised of several components in addition to the API, including excipients, stabilizers, a container and container closure system. High concentration formulations pose challenges related to API stability and stabilizer and excipient degradation. Successful high concentration formulation and delivery systems require an effective control strategy that addresses all aspects of this complex drug product. This presentation will review current knowledge on high concentration formulations and associated analytical challenges.