Bioprocessors face many challenges that range from personnel to production facilities. “As the entire industry has witnessed, competition to recruit qualified and experienced talent to gene therapy manufacturing roles is fierce,” says Kee-Hong Kim, PhD, chief technology officer at Tenaya. In addition, bioprocessors require advanced production facilities. On 16 June, Tenaya Therapeutics announced the completion of its Genetic Medicines Manufacturing Center in Union City, CA.
According to Kim, “We have completed construction and customization of about 50% of the 94,000 square foot facility, which utilizes a flexible, modular design.” This center includes manufacturing suites, quality-control labs, warehouse space, cold storage, office space, and utilities to support the production of Tenaya’s gene therapy drug candidates.
“The facility’s modular design and available excess square footage will provide the flexibility to scale our manufacturing capacity to meet potential, future clinical and commercial production needs for our pipeline,” Kim says. This pipeline consists of adeno-associated virus gene therapies, such as TN-201, which Tenaya is developing for the treatment of genetic hypertrophic cardiomyopathy caused by mutations in MYBPC3.
“The facility is capable of manufacturing viral gene delivery systems,” notes Kim. “We can produce multimodal products using a manufacturing platform that will help us optimize safety, efficacy, and quality to meet each unique target product profile.” To achieve these objectives, Tenaya “focused on developing multiple plug-and-play AAV vector manufacturing processes and assays,” Kim explains. “After successful production and release of robust and safe starting and ancillary materials, the key challenges we faced were process development and scaling up as well as developing and qualifying product specific non-compendial assays.”
As Kim points out, “Our success comes from a number of critical factors, but we truly believe that having a highly qualified and committed team, an excellent work environment that places a high value on manufacturing expertise, and a strong culture are the root cause.” Staying ahead in bioprocessing depends on this combination of company values, personnel, and production facilities.