| Autor: |
Klaus Wuchner, Linda Yi, Cyrille Chery, Felix Nikels, Friederike Junge, George Crotts, Gianluca Rinaldi, Jason A. Starkey, Karoline Bechtold-Peters, Melissa Shuman, Michael Leiss, Michael Jahn, Patrick Garidel, Rien de Ruiter, Sarah M Richer, Shawn Cao, Sebastian Peuker, Sylvain Huille, Tingting Wang, Virginie Le Brun |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
Journal of pharmaceutical sciences. 111(5) |
| ISSN: |
1520-6017 |
| Popis: |
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 (upcoming) will focus on understanding, monitoring, prediction, and mitigation of PS degradation pathways to develop an effective control strategy. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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