Isolere Bio by Donaldson Passes Most Significant Milestone To-Date, Announces Availability of Manufacturing-Grade IsoTag™ AAV Reagent
Donaldson Company, Inc. (DCI)
Last donaldson company, inc. earnings: 3/5 07:02 am
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Source: Business Wire
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Isolere Bio by Donaldson, an innovative bioprocessing technology provider, proudly announces the availability of its manufacturing-grade IsoTag™ AAV reagent for the purification of Adeno-associated Virus (AAV) vectors. As indicated during the launch of the research-grade reagent in October 2024, this final advancement in product grade now includes production with validated processes and the availability of a full suite of documentation, including a Regulatory Support File (RSF), validation guide and full design history upon customer request. Additionally, the U.S. Food and Drug Administration (FDA) has acknowledged its receipt of the recently submitted Drug Master File (DMF) for the IsoTag™ AAV reagent, which will support and streamline clinical manufacturing using the reagent.IsoTag AAV reagent is based on liquid-liquid phase separation technology, originally performed at the Chilkoti biomedical engineering lab at Duke University, da
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