|
|||||
|
|
Non-specific binding and saturation of Polysorbate-20 with aseptic filter membranes for drug substance and drug product during mAb production |
|
| Authors: | Joe X Zhou Jinshu Qiu Ge Jiang Chengfeng Zhou Neil Bingham Helena Yeung Bryan Dransart Manpreet-Vick Wadhwa Tim Tressel |
| Institution: | 1. Purification and Analytical Sciences, Amgen Inc., United States;2. Drug Product and Device Development, Amgen Inc., United States;3. Process Development, Global Process Engineering, Amgen Inc., United States;4. Quality Product Resources, Amgen Inc., United States |
| Abstract: | 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. |
| Keywords: | Non-specific binding Polysorbate-20 Filter membranes |
| 本文献已被 ScienceDirect 等数据库收录！ | |