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The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.
Lyophilization remains an integral step in the manufacturing process for certain biotherapeutics, as was demonstrated with the COVID-19 vaccines. Lyophilization is also important in traditional biologic manufacturing and for emerging therapies. However, there remains inherent risk in subjecting these biomolecules through successive freeze-thaw cycles, which call for best-practice procedures to ensure that product viability and stability are maintained during the lyophilization process. Furthermore, questions have arisen about the long-term sustainability of current lyophilization techniques as the development of new biologic and emerging therapy drug candidates continues to grow.
1. EC, “EU Legislation to Control F-gases,” ec.europa.eu, accessedJan. 14, 2022.
Feliza Mirasol is the science editor for Pharmaceutical Technology and Pharmaceutical Technology Europe.
Pharmaceutical Technology
eBook: Trends in Manufacturing
May 2022
Pages: 22-29
When referring to this article, please cite it as F. Mirasol, “Plan Early: Optimizing Stability During Lyophilization,” Pharmaceutical Technology Trends in Manufacturing eBook (May 2022).
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