Leveraging single-pass tangential flow filtration to enable decoupling of upstream and downstream monoclonal antibody processing
| Autor: | Sanaa Elouafiq, Alex Brinkmann, Matthew Westoby, John Pieracci |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
0106 biological sciences
0301 basic medicine Single pass business.industry Upstream and downstream (transduction) Cell Culture Techniques Temperature Antibodies Monoclonal CHO Cells Hydrogen-Ion Concentration Protein Engineering 01 natural sciences Cross-flow filtration 03 medical and health sciences 030104 developmental biology Cricetulus 010608 biotechnology Volume reduction Environmental science Animals Process engineering business Decoupling (electronics) Filtration Biotechnology |
| Zdroj: | Biotechnology progress. 34(2) |
| ISSN: | 1520-6033 |
| Popis: | Decoupling upstream and downstream operations in biopharmaceutical production could enable more flexible manufacturing operations and could allow companies to leverage strategic or financial benefits that would be otherwise unattainable. A decoupling process was developed and scaled up utilizing single-pass tangential flow filtration for volume reduction, followed by bulk freezing in single-use bags prior to purification. Single-pass tangential flow filtration can be used to continuously concentrate harvested cell culture fluid, reducing the volume by 15-25× with a step yield of >96%. These concentration factors were reproduced with a second product, indicating that the process could be amenable to platform processes. Experimental data indicate that the product tested was stable for at least one year at -40 or -70°C. The concentration of the harvested cell culture fluid-either with or without a subsequent period of frozen storage-had no impact on the product quality attributes that were tested. © 2018 American Institute of Chemical Engineers Biotechnol. Prog., 34:405-411, 2018. |
| Databáze: | OpenAIRE |
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