CORNERSTONE program integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of Gene Therapy Medicinal Products (GTMPs). Portfolio includes novel CIMasphere™ technology for higher yielding processes and safer products in AAV-based programs
BIA Separations, a leading bio-chromatography development and manufacturing company, today announced the introduction of CORNERSTONE AAV Process Development Service, a program of integrated process development services and novel technology designed to improve the robustness and yield of AAV-based gene therapy production, while improving the safety of therapeutic products. Through its CORNERSTONE program, the Company aims to help drug-developers overcome critical development bottlenecks in the production and purification of AAVs and other GTMP vectors. This will allow promising new treatments to be brought more rapidly to clinical trials, ultimately delivering medicines sooner to patients.
It is currently both challenging and expensive to precisely and reproducibly manufacture commercial-scale volumes of viral and non-viral vectors that meet rigorous industry safety standards. Representing the first in a series of CORNERSTONE product programs to be introduced, BIA Separations’ CORNERSTONE AAV Process Development Service provides access to the Company’s extensive expertise in process development and introduces novel CIMasphere™ technology to specifically address the removal of dangerous impurities such as host-cell protein, host-cell DNA and their complexes from manufacturing processes to deliver ultra-pure AAV products.
Host-cell DNA and proteins are among the most problematic contaminants to remove during AAV manufacture, appearing as tightly packed complexes in the form of chromatin. Typical commercially available nucleases struggle to break down chromatin, as it is protected by host-cell DNA’s strong histone associations. In contrast, CIMasphere takes advantage of these strong associations, and uses them to selectively remove the contaminants that cause the most problems during purification.
Pete Gagnon, Chief Scientific Officer at BIA Separations, commented: “The cornerstone of any new construction project defines it future. This is the principle behind our process development program, and we look forward to it becoming the cornerstone of many clinical successes. Over the coming months, we will introduce additional tools and procedures to help scientists meet the unique challenges they face with bringing new therapeutic classes to clinical trials, and eventually to commercial production. Starting with AAVs, the program will expand to include other viral vectors, exosomes, mRNA, and DNA plasmids, among other emerging prospects.”
Ingo Nagler, Business Development Officer at BIA Separations, said: “The launch of our CORNERSTONE program reflects BIA Separations’ transition from a product supplier to a full-service solutions company for gene therapy. We have the requisite experience and know-how, alongside real breakthrough technologies that have potential to significantly accelerate the pace of gene therapy programs for our clients. Our new service responds to an urgent need in the biopharmaceutical industry for turn-key gene therapy production processes, and we believe we are ideally placed to deliver these.”