Session 1: Allogeneic Cell Therapy Facilities and Design
2:00 PM – 2:45 PM | East Red Level, Suite 10
Allogeneic Cell Therapy Facilities and Design
Autologous, or patient specific cell therapies have achieved significant success since their first US commercial approval in 2017. While initial approvals have been for CAR-T cell therapies to treat hematological malignancies, a new generation of cell therapies are emerging. These next generation cell therapies expand beyond autologous therapies into allogeneic or donor derived therapies as well as utilize not just T cells, but also NK cells, iPSCs, as well as other cell types as a source for therapeutics. This next generation of cell therapies holds the promise of more efficient manufacturing, lower costs, an enhanced safety profile, and an increased globalization potential. However, it is not without its own challenges, including limited equipment technology and manufacturing capacity. Vertex Pharmaceuticals is pioneering the next generation of cell therapies. In this presentation, we will discuss the potential of two different cell therapy products; an ex vivo autologous stem cell therapy that is gene edited for the treatment of sickle cell anemia and an allogeneic stem cell therapy that is differentiated for the treatment of Type I Diabetes. Due to the difference in cell sourcing, technology, and therapeutic indication, the facilities for manufacturing these two products are very different. We will compare and contrast these two facilities and discuss the challenges that occur when manufacturing these next generation therapies.
Speakers:
Emily Heffernan, US Director New Process Technologies, Arcadis
Mark Melilli, Chemical Engineer, Vertex
Biographies
Emily Heffernan, US Director New Process Technologies, Arcadis
Emily Heffernan, US Director New Process Technologies, is a process Subject Matter Expert, specializing in biological process and facility design. With over 20 years’ experience, her expertise spans across multiple therapeutic areas including monoclonal antibodies, vaccines, cell and gene therapies, and RNA therapeutics. In her current role, Emily works with biotechnology companies to bring new and emerging life science technologies to market. Emily is an accomplished speaker and author and frequently presents at industry leading events across the United States and Europe including conferences for ISPE, PDA, and Interphex.
Mark Melilli, Chemical Engineer, Vertex
Mark Melilli is a Chemical Engineer who has been working in the Biotech industry for 12 years including biologics, autologous cell therapy, allogenic cell therapy, gene editing, and gene therapy. Mark has been involved with the facility design and construction for various cell and gene therapy clinical manufacturing as a design engineer, CQV engineer, and project engineer. In his current role he is responsible for bringing small scale Cell & Gene therapy treatments to larger populations as Vertex builds out Phase 3 and Commercial Manufacturing.
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