-+ 0.00%
-+ 0.00%
-+ 0.00%

Isolere Bio By Donaldson Announces Availability Of Manufacturing-grade IsoTag AAV Reagent For Purification Of AAV Vectors

Benzinga·04/24/2025 14:04:40
Listen to the news

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.