These include production titer, the ability to upscale production processes, regulatory burden, and other factors. We have not only gone through and understood how to establish the validation of your process, but established validation of the methods that you use to confirm your process is what you … Tony Hitchcock Technical Director Cobra Biologics . Significant Market Potential. Manufacturing processes and protocols that assure safety, purity, and consistency of gene-based therapies are critical to the approval process, whereas a cost-effective manufacturing process is essential for commercial success. Production titer is a key factor as higher titer results in a smaller, more cost-effective production process. Segregation of manufacturing operations involving viruses is a crucial consideration when designing processes and overall facilities. Unlike traditional biologic drugs, gene therapy production can involve the manipulation of replication of viruses. July 1, 2017 (Vol. BIOPHARMA DIVE: What sticking points are there still to get past in gene therapy manufacturing? MARRAZZO: This has been no small task to go from scratch to a first-approved gene therapy facility. 13). The way that such products are produced also matters. There are several factors that can influence the cost of viral based gene therapy manufacturing. In-House Manufacturing Considerations for Cell and Gene Therapy Production by Allan Bream Monday, September 28, 2020 6:09 pm Manufacturing and facility challenges facing cell and gene therapy companies are similar to but more complex than those encountered by companies that produce traditional biopharmaceuticals such as vaccines, monoclonal antibodies, and other therapeutic proteins. Plasmid DNA is the key raw material used in transient transfection and until the process is optimized to reduce the number of plasmids required, the increase in gene therapy production is putting pressure on plasmid-makers to … Another unique aspect of gene therapy manufacturing is the use of transient transfection, which is how DNA is delivered to the cell being used to make the virus. Building Processes for the Future. 37, No.