Lyophilization of Biologics: An FDA Perspective
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abstract
Lyophilization has become an important part of the biopharmaceutical industry as more biological entities are being explored as therapeutic agents. For biologics, whose formulation and storage in aqueous solution result in instability, lyophilization represents the most common and important formulation strategy to improving their long-term stability. The process of lyophilization is a complex, multistep process that requires a sound understanding of both product and process-related attributes to ensure higher operational efficiency and consistently acceptable final product.
