Policy & Regulation
Tenaya Therapeutics Launches Operations of New Genetic Medicines Manufacturing Center
17 June 2022 - - US-based biotechnology company Tenaya Therapeutics, Inc. (NASDAQ: TNYA) has completed the build-out and operational launch of its Genetic Medicines Manufacturing Center in Union City, California, the company said.

Tenaya is advancing a pipeline of therapeutic candidates, including several adeno-associated virus gene therapies, for the potential treatment of both rare and prevalent forms of heart disease.

Tenaya's Genetic Medicines Manufacturing Center is designed to meet regulatory requirements for production of AAV gene therapies from discovery through commercialization under Current Good Manufacturing Practice standards.

Initial production efforts will support first-in-human studies of Tenaya's lead gene therapy, TN-201.

TN-201 is being developed for the treatment of genetic hypertrophic cardiomyopathy due to MYBPC3 gene mutations.

Tenaya plans to submit an Investigational New Drug application for TN-201 to the US Food and Drug Administration in the second half of this year.

The facility will also support cGMP production for TN-401, Tenaya's gene therapy program being developed for the treatment of genetic arrhythmogenic right ventricular cardiomyopathy due to PKP2 gene mutations, for which the company plans to submit an IND to the FDA in 2023.

Tenaya completed customization of approximately half of the 94,000 square foot facility to incorporate manufacturing suites and labs, office space and storage.

Utilizing a modular design, the facility is now fully operational with initial capacity to produce AAV-based gene therapies at the 1000L scale, utilizing Tenaya's proprietary baculovirus-based production platform and suspension Sf9 cell culture system.

The excess space and modular design of the Genetic Medicines Manufacturing Center is intended to provide Tenaya with considerable flexibility to expand manufacturing capacity by increasing both the number and the scale of bioreactors to meet future clinical and commercial production needs.

The Union City location, approximately 30 miles from Tenaya's South San Francisco headquarters, is expected to enable the seamless transition of Tenaya's science from early research through commercial manufacturing.

The selection of this location is intended to foster a culture of close collaboration across teams at all stages of developing and testing novel AAV capsids, de-risk the translation from research to process development and create opportunities for improvements in production processes.

The Genetic Medicines Manufacturing Center is staffed by a growing in-house team with expertise in all aspects of gene therapy manufacture, including process development, analytical development, quality assurance and quality control.

Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease.

Founded by cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic cardiovascular disorders, as well as for more prevalent heart conditions, through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine.


Related Headlines