- Isolere Bio by Donaldson announces the availability of its manufacturing-grade IsoTag™ AAV reagent.
- The U.S. FDA acknowledges receipt of the Drug Master File for the IsoTag™ AAV reagent.
- The product aims to streamline clinical manufacturing of AAV vectors, supporting GMP manufacturing processes.
Isolere Bio by Donaldson, a leader in bioprocessing technology, has achieved a major milestone with the release of its manufacturing-grade IsoTag™ AAV reagent. This product, designed for the purification of Adeno-associated Virus (AAV) vectors, represents a significant advancement in biopharmaceutical purification technologies.
The IsoTag™ AAV reagent, which employs liquid-liquid phase separation technology, was initially developed at Duke University’s Chilkoti biomedical engineering lab. Isolere Bio began collaborations using the IsoTag™ AAV under Material Transfer Agreements in 2021 and made it commercially available in 2023.
In a key regulatory development, the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Drug Master File (DMF) for the IsoTag™ AAV reagent. This move is expected to support and streamline the clinical manufacturing of gene therapies utilizing this innovative reagent.
The company will feature its novel solutions at the upcoming American Society of Gene & Cell Therapy (ASGCT) conference in New Orleans, highlighting its commitment to advancing the efficiency and affordability of life-changing therapies.
For more information about Isolere Bio and its offerings, visit their official site at isolerebio.com.
Donaldson Company, Inc. (DCI, Financial), which acquired Isolere Bio in early 2023, continues its expansion into the Life Sciences sector. With a focus on Smarter Bioprocessing solutions, Donaldson’s Bioprocessing division plays a crucial role in enhancing global health by delivering innovative technologies from R&D to commercialization.
