Non-specific binding and saturation of Polysorbate-20 with aseptic filter membranes for drug substance and drug product during mAb production
| Autor: | Jinshu Qiu, Neil Bingham, Bryan Dransart, Helena Yeung, Ge Jiang, Manpreet-Vick S. Wadhwa, Tim Tressel, Chengfeng Zhou, Joe X. Zhou |
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| Rok vydání: | 2008 |
| Předmět: |
Drug
Chromatography medicine.drug_class media_common.quotation_subject Filtration and Separation Monoclonal antibody Biochemistry Polyvinylidene fluoride chemistry.chemical_compound Membrane chemistry Pulmonary surfactant medicine General Materials Science Polysorbate 20 Aseptic processing Physical and Theoretical Chemistry Saturation (chemistry) media_common |
| Zdroj: | Journal of Membrane Science. 325:735-741 |
| ISSN: | 0376-7388 |
| DOI: | 10.1016/j.memsci.2008.08.046 |
| Popis: | An issue identified during filtration of mAb drug substance is Polysorbate-20 absorption by polyethersulfone filter membranes. Experiments determined that both polyvinylidene fluoride filter membranes and polyethersulfone filter membranes bind Polysorbate-20. Saturation point, bound surfactant amount per square cm of membrane, and non-specific binding mechanisms are described in this report. An appropriate approach for preventing Polysorbate-20 loss in drug substance and drug product is presented. |
| Databáze: | OpenAIRE |
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