Isolere Bio by Donaldson announced on April 24, 2025, the availability of its manufacturing-grade IsoTag™ AAV reagent, designed for the purification of Adeno-associated Virus (AAV) vectors. This marks a significant milestone, following the launch of its research-grade counterpart in October 2024.
The manufacturing-grade reagent includes validated processes and a full suite of documentation, including a Regulatory Support File (RSF) and validation guide. The U.S. Food and Drug Administration (FDA) has acknowledged receipt of the submitted Drug Master File (DMF) for the IsoTag AAV reagent, which will support clinical manufacturing.
This innovative reagent utilizes liquid-liquid phase separation technology, combining affinity- and size-based separations to streamline purification processes for gene therapies. The product aims to address critical bottlenecks in GMP manufacturing, enabling faster and more affordable delivery of AAV-based gene therapies to patients.
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