Surfactant replacement options for Triton X-100 in bioprocessing

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作者
Matte, Allan [1 ]
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[1] Downstream Processing Team, Human Health Therapeutics Research Center, National Research Council, Canada
来源
European Pharmaceutical Review | 2024年 / 29卷 / 03期
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摘要
The implementation of REACH regulations impacting use of Triton X-100 in bioprocessing within the EU is having an impact on sponsors and manufacturers as they look to detergent alternatives for their processes for new manufactured products. Drug developers in non-EU jurisdictions have also been following these changes and considering the overall risk environment and how to respond appropriately to these changes. The increased variety of REACH-compliant, high-quality detergents that can be tested for either cell lysis or adventitious virus reduction continues to grow, offering process developers of biologic drugs a variety of potential options, depending on the specific requirements of their process and product. © 2024 Russell Publishing. All rights reserved.
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页码:40 / 43
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