Polysorbates (PS) are widely used as a stabilizer in biopharmaceutical products. Industry practices on various aspects of PS are presented in this part 1 survey report based on a confidential survey and following discussions by 16 globally acting major biotechnology companies. The current practice and use of PS during manufacture across their global manufacturing sites are covered in addition to aspects like current understanding of the (in)stability of PS, the routine QC testing and control of PS, and selected regulatory aspects of PS. The results of the survey and extensive cross-company discussions are put into relation with currently available scientific literature.
Part 2 of the survey report focuses on understanding, monitoring, prediction, and mitigation of PS degradation pathways to develop an effective control strategy.
Michael Jahn, Ph.D, Director, Head Forensic Chemistry
Virginie Le Brun, Associate Director, Formulation Development