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22 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Biologics L yophilization remains an integral step in the manufactur- ing process for certain biotherapeutics, as was demonstrated with the COVID-19 vaccines. Lyophilization is also impor- tant 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, ques- tions have arisen about the long-term sustainability of current lyophi- lization techniques as the development of new biologic and emerging therapy drug candidates continues to grow. Challenges with emerging therapies One big bioprocessing challenge posed by the lyophilization of emerging biotherapeutics, such as cell therapy, gene therapy, and nucleic-acid- based therapies (e.g., the mRNA-based vaccines), is a general impact on machine technology. The shift from small-molecule pharmaceuticals to biologics has also changed the manufacturing requirements because of the nature of the products, explains Jörg Rosenbaum, director product management at Hesse, Germany-based Optima Pharma. "Biologics are fragile products that cannot tolerate heat and have a limited stability. Lyophilization is a very important process in biotherapeutics manufacturing to improve product stability," Rosenbaum states. Factors that have made the lyophilization of biologic drug prod- ucts challenging include the equipment requirements. The equipment Plan Early: Optimizing Stability During Lyophilization Feliza Mirasol The need for sustainability and early considerations of a lyophilization strategy grows more pertinent on the back of growing biologics volume. MAGIORESTOCKSTUDIO - STOCK.ADOBE.COM