Alan Moore is responsible for cGMP-compliant contract manufacturing of innovative cell and gene therapies in WuXi’s Philadelphia-based manufacturing sites as well as support of WuXi’s strategic biopharmaceutical clients. Over the years, Alan Moore has presented on biopharmaceutical, cell and gene therapy development and safety to the U.S. FDA Center for Biologics Evaluation and Research, various U.S. FDA Advisory Committees, Health Protection Branch, Drugs Directorate (Canada), Therapeutic Goods Administration (Australia), Japan Health Science Council (Ministry of Health), and the U.K. Xenotransplantation Interim Regulatory Authority (UKXIRA). Alan provides a wealth of experience in cell and gene therapy in the U.S. and abroad. We had a moment to talk with him about WuXi’s services in cell and gene therapy in the U.S. and the prospects for cell and gene therapy in Israel.
What inspired you to join WuXi after thirty years of supporting biological products and cell-based therapies?
Alan: I was very impressed with the potential to leverage the existing facilities and testing capabilities resident in Philadelphia to build an integrated platform for the manufacture of the growing number of innovative cell and gene-mediated therapies. When I was at Genzyme, I was responsible for the manufacture of a patient-specific cell-based vaccine in a phase 3 clinical study with the U.S. National Cancer Institute. There are many challenges in manufacturing these types of products so I was delighted to find all of the right capabilities under one roof at WuXi.
What can you tell us about those capabilities for the manufacture of cell and gene-mediated cell therapies?
Alan: WuXi has been very excited about the potential for cell and gene-mediated therapies like CAR-T cell products. We have established process development and cGMP manufacturing capabilities for autologous (patient-specific) and allogeneic (off the shelf) cell therapies as well as specialized segregated manufacturing suites for the products which employ viral vectors, such as CAR-T cell products. We have supported phase 3 clinical manufacturing of cell therapies and are in the process of preparing for the launch of a commercial cell therapy product.
There has been recent press coverage of WuXi’s facility expansion for cell therapy manufacturing; can you tell us a little bit more about that?
Alan: We are just bringing on-line four additional manufacturing suites, about 2,600 sq.ft, in our current building that are intended for gene-mediated product manufacturing or vector production. This supplements the existing 16,000 sq.ft manufacturing area for autologous and allogenic products. In addition, we have recently completed construction of a second manufacturing building which permits U.S. and EU-compliant manufacturing facility for cell therapies which when fully built -out will total 45,000 sq.ft. This building is in commissioning now. We also have begun construction of a third facility which will provide 150,000 sq.ft of US and EU-compliant manufacturing for CAR-T cell production and viral vector manufacturing.
Are there other capabilities beyond manufacturing that can benefit WuXi’s cell and gene therapy partners?
Alan: Absolutely! Our manufacturing partners point out that having access to our biosafety, analytical and medical device services provides convenience and speeds their progress to the clinic. These services have been supporting US and European products for decades and have very mature compliance standards. The quality control and lot release paradigms for these products are sometimes very aggressive, so it helps to have these as integrated services when trying to get products to patients quickly.
What are your thoughts on how WuXi is supporting the growth in cell therapy and the resurgence of gene therapy?
Alan: There has been significant investment in companies developing cellular, gene-mediated cell therapies like CAR-T cells, and genetic therapies fueled by dramatic clinical results. We have asked the question – how do we best assist in the advancement of these exciting therapies? The answer includes a broadening of our capabilities and making sure that we have the depth of competencies required. We have built expanded process development capabilities with both early and late stage development services, since many of these projects have accelerated regulatory pathways. That translates to having the right expertise to optimize an early stage process which may be used to gain approval and to assist with a process that will serve the demands of commercial manufacturing. As to depth of competencies, we are investing in large scale facilities, staff and systems which will be required to meet commercial manufacturing requirements for these therapies, which means we are building to the most rigorous standard to allow rapid forward integration of these programs.