By Erin Harris, Editor-In-Chief, Cell & Gene
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Andy Ramelmeier, EVP Technical Operations at Sangamo Therapeutics and I sat down to discuss Sangamo’s plans for its in-house AAV manufacturing facility and the major benefits the facility will bring to genomic medicine and the sector at large.
Why is Sangamo building its own in-house AAV manufacturing facility?
We view manufacturing as essential to our progress. The opening of this Phase 1/2 cGMP AAV in-house facility provides us with greater control of our processes, quality, supply and timeline. The facility is designed to be highly flexible so it can support us now and, in the future, as we advance many medicines.
What were Sangamo’s major considerations around building an in-house AAV manufacturing facility, and who was involved in the decision making?
We are building a diverse pipeline, so our approach to manufacturing must accommodate many needs. For that reason, we approached building our Brisbane in-house facility with a broad three-pillar approach in mind. Namely, we focused on:
- Building balanced and necessary capacity in order to develop in-house capabilities while still leveraging external resources for expanded capacity
- Investing in manufacturing process and analytics so that we establish highly productive processes and more potent AAV vectors
- Developing a strong supply chain where we manage all steps from raw materials to medicines, including sourcing, manufacturing, transportation and storage
Retaining the facilities to quickly scale was also an important consideration, and for that reason we’ve maintained our partnership with ThermoFisher, an experienced CDMO, for our current large-scale Phase 3 and commercial AAV needs.
What are the major benefits to bringing AAV manufacturing in house to a) the patient b) Sangamo c) the sector at large?
As our work progresses from early- to later-stage research and development, we increasingly need to innovate not just in the lab, but also in the ways we bring treatments to patients who need them.
We anticipate multiple benefits from increased speed to clinic to providing us with the capabilities to manufacture both clinical and commercial-grade AAV-based treatments from start to finish. Additionally, we have a phase-appropriate quality system in place that allows us to operate properly and compliantly. This helps us gain control over quality and allows us to be nimble and agile to meet clinical demands and timelines.
We are pioneering a new field of medicine with the goal of not just managing but curing serious diseases — manufacturing is one of the critical steps in evolving our work from the early stages to delivering treatments for patients.
What jobs will have been created as a result of the new facility?
We are heavily investing in this. In fact, 1/3 of our headcount is now dedicated to manufacturing. Building a world class GMP manufacturing facility to scale takes know-how, which is why we have built teams with expertise in quality, supply chain management, technical development, and much more.
As a company, we are hiring at a rapid pace and have hired more in 2020 than in years past. Further, we are recognizing our in-house leaders for our momentum in this area. We recently promoted our own Jas Gill to Chief Quality Officer, given the strides we have made and the importance of quality to our manufacturing processes.
What does building its own AAV manufacturing facility do for Sangamo to set it apart/ahead in the sector, and why?
Our industry is growing so rapidly that many CDMOs are, as a necessity, learning as they go. Early stage processes can be complex and challenging. Building in-house expertise gives us the advantage of being able to rapidly solve challenges at the early stages of development and enable quick delivery to the clinical. Furthermore, when later Phase 3 stage development is needed, we can quickly work with a CDMO and use our learnings to scale.
This Phase 1/2 facility is a key part of our balanced approach to manufacturing. With it, our team is at the cutting-edge, embracing the challenges of making entirely new types of medicine. Every day we are learning, growing, and leading from the front.
Looking ahead, work is underway to build and launch a new cell therapy GMP manufacturing facility in Valbonne, France to support manufacturing for our novel Treg platform and further our efforts toward establishing a world-class gene and cell therapy manufacturing organization.