Research Triangle Park, NC – Isolere Bio by Donaldson, an innovative bioprocessing technology provider, proudly announces the availability of research-grade IsoTag™ AAV reagent, for the purification of adeno associated viral vectors (AAV). The research-grade IsoTag™ AAV reagent marks a significant advancement from its prototype grade. It maintains the same non-chromatographic purification capabilities, but now provides enhanced reliability and quality including animal-origin free production under an ISO 9001 certified quality management system.

first-of-its-kind reagent for the purification of target biologics, IsoTag™ AAV reagent was developed from cutting edge technology spun out of the Chilkoti biomedical engineering lab at Duke University. The specialized reagent is compatible with a multitude of AAV serotypes, achieves up to 85% yield and provides a 4-log reduction in host cell proteins and DNA with a processing time of less than 4 hours. The novel reagent combines affinity capture and liquid-liquid phase separation, eliminating the need for traditional affinity chromatography. This innovative method features an AAV-specific affinity ligand paired with a stimulus-responsive biopolymer expressed as a single protein in coli, which is fully biodegradable and requires no chemical conjugation to a solid scaffold. The product effectively captures AAV capsids into micron-sized, protein-rich droplets, which are easily retained using open-pore filters, thereby streamlining the purification process and enhancing overall efficiency in viral vector production.

“Our latest addition to the IsoTag reagent platform represents a significant leap forward in AAV purification for gene therapies,” said Kelli Luginbuhl, General Manager and Co-Founder of Isolere Bio by Donaldson. “By accelerating the purification process to under four hours and enhancing yield, purity, and quality, we are addressing key manufacturing bottlenecks that other technologies using a solid base matrix cannot. As our process, thus far, is titer-independent, it will provide process flexibility as upstream titers continue to improve.”

IsoTag™ AAV reagent is compatible with a wide range of tangential flow filtration (TFF) equipment and off-the-shelf consumables, providing the flexibility needed to meet the growing demand for high-quality AAV vectors from research to commercial production. Isolere Bio by Donaldson is progressing towards manufacturing-grade IsoTag AAV reagent, which will include a suite of quality documentation to facilitate use in a GMP environment. Manufacturing-grade IsoTag AAV reagent is on track to be available in 2025.

Research-grade IsoTag AAV reagent will be available to purchase in a few weeks in North America and Europe.

For more information and to obtain a quote, please reach out to a member of the Isolere Bio team at ww.isolerebio.com/contact.ww.isolerebio.com/contact.

We invite you to join us at the upcoming ESGCT congress in Rome from October 22–25, 2024, at the Donaldson Life Sciences Booth #E21. Isolere Bio, now part of Donaldson Life Sciences, will be showcasing its innovations alongside other products, so you can speak directly with our team. Don’t miss this opportunity to connect and learn more about our groundbreaking solutions!

About Isolere Bio

Isolere Bio by Donaldson is focused on revolutionizing biomanufacturing with innovative purification technologies. The company works diligently to enhance the efficiency, purity, and cost-effectiveness of biopharmaceutical processes by leveraging cutting-edge materials into next generation solutions. Each product is designed with scalability and sustainability in mind to enable customers to rapidly and reliably commercialize life-saving therapies.

Incorporated in 2017, Isolere Bio became part of Donaldson Company (NYSE: DCI) in early 2023.

About Donaldson Life Sciences – Bioprocessing

Long a pioneer in filtration solutions, Donaldson Company (NYSE: DCI) continues to expand in Life SciencesThe Bioprocessing division is concentrated on developing solutions from R&D to commercialization for multi-modality drug manufacturers. The division was built via acquisitions of Isolere Bio for multi-modality reagents; Solaris Biotech and UnivercellsTechnologies for innovative production technologies; and Purilogics for bioprocessing membranes. These teams are driven to continuously innovate, evolve, and deliver Smarter Bioprocessing solutions that help developers improve global health.