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ASTM’s E-55.05 committee aims to turn best practices into industry standards in order to eliminate variability and allow a 70-year-old process to leverage 21st century tools, technologies, and practices.
Despite its importance to the pharmaceutical industry, lyophilization has seen relatively little change since it was introduced in the 1940s. This has led to a disconnect between current practice and market needs. LyoHub, a consortium of pharma and biopharmaceutical manufacturers, equipment designers and suppliers, researchers, and academics with participation from regulatory bodies, is trying to address this problem. LyoHub is now working with the American Society for Testing and Materials International’s E-55 Committee to make its proposed best practices into industry standards. This article gives insight into E-55.05’s goals for optimizing lyophilization.
eBook: Biologics and Sterile Drug Manufacturing 2018
When referring to this article, please cite it as A. Shanley, "Can Standards Help Pharma Modernize Lyophilization?" Pharmaceutical Technology Biologics and Sterile Drug Manufacturing 2018 eBook (May 2018).