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The freezing and thawing of biologics for storage and transport is often overlooked in the biomanufacturing workflow. Considering its impact on critical quality attributes in post downstream processing, it should be treated as a unit operation of its own. And like most unit operations, freeze/thaw has its own set of process challenges focused on product stability, integrity, and scalability. For commercial scale freeze/thaw of bulk API, a model protein study can help to better understand how formulations, primary containers, and freezing methods alleviate these risks.