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Effect of Fatty Acid Composition in Polysorbate 80 on the Stability of Therapeutic Protein Formulations |
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| Authors: | Pegues Melissa A. Szczepanek Karol Sheikh Faruk Thacker Seth G. Aryal Baikuntha Ghorab Mohamed K Wolfgang Steven Donnelly Raymond P. Verthelyi Daniela Rao V. Ashutosh |
| Affiliation: | 1.Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA ;2.Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA ;3.Laboratory of Immunology, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA ;4.Policy Development and Evaluation Branch 1, Division of Regulations, Guidance and Standards, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA ;5.Cosmetics Regulatory Activities Branch, Cosmetics Division, Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, College Park, MD, 20740, USA ; |
| Abstract: | Pharmaceutical Research - Polysorbate excipients are commonly used as surfactants to stabilize therapeutic proteins in formulations. Degradation of polysorbates could lead to particle formation and... |
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