BIA Separations has launched Cornerstone, a set of services designed to facilitate adeno-associated virus (AAV) production.
The first service to be provided through the Cornerstone program is a purification technology called CIMasphere, which enables the removal of impurities such as host-cell protein, host-cell DNA and their complexes prior to the manufacturing processes, in order to deliver ‘ultra-pure’ AAV products.
Pete Gagnon, BIA Separations’ CEO, said in a statement that the company plans to introduce additional tools over the coming months, as well as to include other viral vectors, exosomes, mRNA, and DNA plasmids in the Cornerstone program.
The newly-launched service is expected to respond to an ‘urgent’ need in the biopharmaceutical industry for turn-key gene therapy production processes, according to Ingo Nagler, the company’s business development officer.
Earlier this year, the company entered an agreement with AveXis for the commercial purification process of SMA gene therapy drug Zolgensma (onasemnogene abeparvovec-xioi), as well as further gene therapy candidates in the latter’s pipeline.
Breaking down tightly packed chromatins
According to the company, host-cell DNA and proteins are among the most problematic contaminants to remove during AAV manufacture, since they appear as tightly packed complexes in the form of chromatin.
“Commercially available nucleases for purification processes struggle to break down chromatin, as it is protected by host-cell DNA’s strong histone associations,” the company stated.
In contrast to that, BIA Separation’s CIMasphere technology takes advantage of these strong associations and uses them to selectively remove the contaminants that cause ‘the most problems’.
Shifting to bioprocessing services
Commenting on the launch, Ingo Nagler said that it reflects a transition for BIA from a product supplier to a service provider for gene therapies development.
In late 2018, the company expanded its facilities in Ajdovščina, Slovenia, with the addition of an upstream laboratory, allowing the production of viral vectors, phages, and exosomes, as well as better management of the transition between upstream and downstream processing.
The addition of the laboratory followed a collaboration agreement with Nuvonis Technologies, under which BIA gained access to the latter’s cell bank.