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.
Read this article in the Trends in Manufacturing ebook.
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).
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications
December 10th 2024This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.