Biopharmaceutical raw material variation and control
| Autor: | Jason E. Dickens, Dave Kolwyck, Kelly Wiltberger, Thomas E. Matthews, Sarwat F. Khattak |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
0106 biological sciences
0301 basic medicine De facto Computer science Process (engineering) media_common.quotation_subject Raw material Integrated approach 01 natural sciences 03 medical and health sciences 030104 developmental biology General Energy Biopharmaceutical industry Biopharmaceutical Variation (linguistics) 010608 biotechnology Biochemical engineering Function (engineering) media_common |
| Zdroj: | Current Opinion in Chemical Engineering. 22:236-243 |
| ISSN: | 2211-3398 |
| Popis: | The current paradigm for raw material control in the biopharmaceutical industry remains a combination of compendial tests, function-based test and engineering controls. Moreover, ad hoc scale-down process studies remain the de facto approach to understand raw material variation challenges. The biopharmaceutical industry, however, continues to experience the impact of raw material variation are current approaches are insufficient to assess key raw material attributes. Here we review the current state of raw material variation and its biopharmaceutical impact along with analytical methods optimized for raw material characterization. A systematic raw material characterization and control strategy is then outlined as an integrated approach to address cell culture raw material variation challenges. This comprehensive long-term approach can be applied throughout the biopharmaceutical manufacturing process and across further modalities such as small molecules, proteins, and other cellular therapies. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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