Tenaya launches operations at its California plant

The modular facility in Union City, California will support the development of cardiovascular gene therapies and lessen Tenaya Therapeutics’ reliance on CDMOs.

The firm announced its plans for the Genetic Medicines Manufacturing Center after a $106 million Series C funding round in April 2021.

The 94,000 square-foot modular facility will advance a pipeline of adeno-associated virus (AAV) gene therapy candidates for the potential treatment for heart disease, including lead programs TN-201 for genetic hypertrophic cardiomyopathy (gHCM) and TN-401 for arrhythmogenic right ventricular cardiomyopathy (ARVC).

Image: Stock Photo Secrets

With operations set to begin, we spoke with Tenaya CEO Faraz Ali to find out more:

BPI: Talk us through the financials and the set-up surrounding the facility

Faraz Ali (FA): We took over the space in Union City, California in May of 2021 and completed construction of Tenaya’s Genetic Medicines Manufacturing Center in under a year. Approximately 50 percent of the 94,000 square foot warehouse space has been built out, and it is comprised of manufacturing, quality control labs, cold storage, utilities and office space.

The facility is designed to meet regulatory requirements for production of AAV gene therapies, from discovery through commercialization, under Current Good Manufacturing Practice (cGMP) standards.

We spent approximately $45 million on the overall construction and customization of the space and related capital expenditures. We believe this investment will give us more control over our overall manufacturing-related costs and timelines relative to relying on contract development and manufacturing organizations (CDMOs).

Our choice to go with a modular, pod-based design for this facility allows us to add to that financial investment rationally and incrementally and in a risk-adjusted manner, over time, in response to new information related to the development of our product candidates.

BPI: What are the advantages of operating out of Union City?

FA: We made a deliberate choice to construct our Genetic Medicines Manufacturing Center in the San Francisco Bay Area near Tenaya’s headquarters, where our Research and Process Development (PD) labs are located; Union City is a mere 30 miles away from South San Francisco.

One advantage of this decision is that the same people who are developing, designing, and testing our production processes at up to the 200 L scale in our PD labs can also support the scale-up of those processes to 1000 L and beyond in our cGMP facility.

This proximity creates opportunities for rapid cycles of continuous improvement in upstream and production processes. We believe it will also serve to de-risk the transition of our product candidates across different stages of development, from preclinical to clinical, and eventually through to regulatory approval and commercial launch. The selection of this location was intended to foster a culture of close collaboration between our research and manufacturing teams at all stages of developing and testing our novel AAV capsids, including any candidates with specific properties beneficial to cardiac gene therapy that may require adjustments to standard manufacturing processes. Last, but not least, there are also some cost and capacity utilization advantages associated with having these two facilities in close proximity to each other.

BPI: What advantages are there from having inhouse capabilities?

FA: We have made very deliberate choices and investments to internalize and integrate several core capabilities that we believe can have a significant impact on key attributes of our product candidates, including safety, efficacy, durability, scalability, consistency, and cost. Our decision to bring all manufacturing-related capabilities for our gene therapy products in-house is a significant part of that strategy.

The creation of this Genetic Medicine Manufacturing Center provides Tenaya with greater control over those critical-to-quality product attributes as well as over our production timelines and costs. We are well-positioned to mitigate manufacturing-related risks as our product candidates transition across stages of development, from preclinical to clinical to final regulatory approval and eventual commercial launch.  We are also positioned to be able to respond quickly and comprehensively in response to evolving CMC-related guidance from regulatory agencies. Importantly, we can adjust nimbly in response to evolving data for our product candidates during clinical development.

BPI: How many people have been hired to work here? How was it recruiting in the current climate?

FA: We have approximately 140 full-time employees at Tenaya, and approximately 40 jobs have been created in connection with our manufacturing efforts. By placing our Genetic Medicines Manufacturing Center in Union City, we are joining a growing number of gene or cell therapy companies and CDMOs who have, in recent years, made similar choices to add their cGMP capacity in the San Francisco Bay Area. As a result, there is a growing pool of local talent to draw on for our recruitment. The manufacturing facility is fully staffed for current needs, and our team at the Genetic Medicines Manufacturing Center brings expertise in all aspects of gene therapy manufacture, including PD, analytical development (AD), quality assurance (QA) and quality control (QC). Given the excess space and modular design of the facility, we can also evolve our capacity to best suit our manufacturing needs in the future. We plan to grow the human footprint of our local manufacturing presence rationally as we continue the development of our products and further build out of the facility.

Hiring in the current environment has gone well for us. With our unique focus on heart disease, we are addressing the leading cause of death in the world with high unmet need. We have a strong sense of mission: to discover, develop, and delivery potentially curative therapies that target the underlying causes of heart disease. We are advancing first-in-class and best-in-class gene therapies for severe genetic forms of heart disease. All of this makes for a compelling story that helps us hire great talent in all departments, including for manufacturing-related roles.

Of course, it’s still a competitive market in the Bay Area, particularly for certain roles in clinical research, regulatory and quality, but we have been fortunate to bring on board highly qualified team members with background in gene therapy discovery, development and manufacturing, cardiovascular drug development and orphan and rare disease expertise.