BIA Separations, a Slovenia-based manufacturer of viral vectors used in cell and gene therapy development, announced an extension to its set of services designed to facilitate adeno-associated virus (AAV) production, known as Cornerstone – launched earlier this month.
Cornerstone will be extended through the use of kryptonase, an integrated enzymatic treatment that reduces host-cell DNA and facilitates the removal of host-cell protein contaminants during the purification process.
Additionally, BIA announced the integration of CIMmultus EV monolithic column, a chromatography device that eliminates non-exosomal vesicles, and concentrates exosomes in a low shear environment.
According to the company, the technologies are available as part of its process development service, with an aim to provide clinical trial support, as well as expansion to industrial-scale manufacturing.
A spokesperson for BIA Separations told us that the supply of AAVs under the Cornerstone program follows a project preparation and risk assessment process, before the developer receives analytics on the delivered material.
After determining whether nuclease treatment of the material is required and defining the stage where it is required, the company proceeds in the extraction of AAVs using CIMasphere technology.
Subsequently, tangential flow filtration and chromatographic method evaluation is conducted, until the buffer exchange of final products to the client‘s formulation buffer and scale-up is enabled. Following this point, the technology is transferred to the developer’s facility.
According to the spokesperson, the above processing service answers a ‘huge challenge’, as there are currently no blueprints or routine approaches available for guidance.
Therefore, the Cornerstone enables “drug developers looking to develop new gene therapies to provide to their investors/management a plausible path forward to reaching investigational new drug-stage with pure and safe AAV products in the required timeframes,” the spokesperson noted.