Isolere Bio by Donaldson has launched its research-grade IsoTag reagent, which is suitable for the purification of adeno associated viral vectors (AAVs).
According to the company, it maintaines the same non-chromatographic purification capabilities, while also providing enhanced reliability and quality.
The reagent also allows for animal-free production under a ISO 9001-certified quality management system.
What is IsoTag?
A first-of-its-kind reagent for purifying target biologics, the IsoTag AAV reagent is compatible with a multitude for AAV serotypes, and can achieve up to 85% yield.
It also provides a 4-log reductionin 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 E. 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.
General Manager and co-founder of Isolere Bio, Kelli Luginbuhl, commented: “Our latest addition to the IsoTag reagent platform represents a significant leap forward in AAV purification for gene therapies,”
“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 is compatible with a range of tangential flow filtration equipment and consumables, providing manufacturers with flexibility when trying to meet the growing demand for AAV vectors.
Donaldson is currently working on a manufacturing-grade IsoTag AAV reagent for GMP manufacturing, and should be available in 2025.