Lyophilization, also known as freeze-drying, is often a crucial step in the manufacturing process of biologics drug products. Biologics are large, complex molecules used to treat various diseases, including cancer, autoimmune disorders, and rare genetic disorders. These molecules can be challenging to chemically and physically stabilize, hence, alternative drug product manufacturing processes must be carefully evaluated and performed to maintain potency and efficacy. Lyophilization is one commonly used technique to stabilize biologics drug products and increase their shelf-life.
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