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What is Process Improvement After IND Submission about?

This document discusses a proposed process change from using ultrafiltration/diafiltration (UF/DF) to remove lysine to using a Dowex cation exchange resin. Two plasminogen lots were produced at toxicology/clinical scale using the Dowex process and were extensively characterized. The results showed the products from the Dowex process were comparable to the UF/DF process lots. The data was submitted to the FDA and the recommendation was made to proceed with implementing the Dowex process for Phase III clinica

Author

gabriel.marquez366

Language

EN