Theoretical and Practical Considerations When Selecting Solvents for Use in Extractables Studies of Polymeric Contact Materials in Single-Use Systems Applied in the Production of Biopharmaceuticals
| Autor: | Isabelle Uettwiller, Samuel Dorey, Ina Pahl, Armin Hauk, Paul Priebe |
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| Rok vydání: | 2018 |
| Předmět: |
Single use
Computer science General Chemical Engineering 02 engineering and technology General Chemistry 010402 general chemistry 021001 nanoscience & nanotechnology 01 natural sciences Industrial and Manufacturing Engineering 0104 chemical sciences Process conditions Biopharmaceutical Biopharmaceutical industry Production (economics) Biochemical engineering 0210 nano-technology |
| Zdroj: | Industrial & Engineering Chemistry Research. 57:7077-7089 |
| ISSN: | 1520-5045 0888-5885 |
| DOI: | 10.1021/acs.iecr.7b04940 |
| Popis: | Regulatory authorities require the biopharmaceutical industry to demonstrate that extractables that may migrate from production systems do not alter the safety, efficacy, potency, or purity of drug products. Extractables studies of polymeric materials used in production systems and in particular single-use systems are designed to show material safety and should support the users to perform risk-based toxicological assessment of leachables that could potentially enter into the final product under process conditions. In this paper, we intend to improve the understanding of solvent–polymer interactions and thereby allow the prediction of extractables from a range of fluids based on their chemical properties. The possibility to predict solvent–polymer interactions and polymer swelling in biopharmaceutical applications based on solubility parameters is introduced. |
| Databáze: | OpenAIRE |
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