MULTIPRODUCT RESIN REUSE (MRR) FOR THE DEVELOPMENT AND CLINICAL MANUFACTURE OF THERAPEUTIC PROTEINS
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United States of America
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Issued Date -
Mar 13, 2025
app pub date -
Aug 9, 2024
filing date -
Aug 9, 2024
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Abstract
The present invention provides a method for multiproduct resin reuse (MRR) utilizing ionic exchange chromatography columns. The methods of the invention outline the cleaning steps necessary for reuse as well as the analytical processes used in determining product carryover from production of one product to the next. The invention outlines a successful MRR strategy that can be utilized not just in lab-scale studies, but in a GMP manufacturing setting.
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