End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics - The AAPS Journal
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| End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics - The AAPS Journal |
| A survey performed by the AAPS Drug Product Handling community revealed a general, mostly consensus, approach to the strategy for the selection of surfactant type and level for biopharmaceutical products. Discussing and building on the survey results, this article describes the common approach for surfactant selection and control strategy for protein-based therapeutics and focuses on key studies, common issues, mitigations, and rationale. |
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Ho-Leung Fung Ph.D., FAAPS
Editor-in-Chief
University at Buffalo
Sarasota FL
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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