Join George Todorov at INTERPHEX as he discusses the process design considerations and emerging technologies for manufacturing gene and cell therapies for a growing patient population Stage 2, Booth #1579.
As the cell and ex-vivo gene therapy industry is rapidly evolving and the number of products entering the clinic is growing exponentially, we as an industry must look ahead and plan accordingly to safely and effectively deliver these revolutionary medicines to a large patient population. Regardless of the specific modality and autologous or allogeneic format, cell therapy manufacturing processes are not yet industrialized and have yet to evolve in order to address the following questions and concerns:
- How does one efficiently scale out or scale up autologous and allogeneic manufacturing processes to meet growing demand?
- How can an inherently open manual process be converted to closed and semi or fully automated manufacturing?
- What does the evolving regulatory landscape for cell and ex-vivo gene therapies push us to anticipate when designing a manufacturing process?
- What should we consider when planning to manufacture multiple patient lots and/or multiple cell therapy products under the same roof?
- How can the cost of manufacturing be lowered to make these life-saving therapies more accessible?
This presentation will walk the audience through process design considerations and emerging technologies to enable late-stage clinical and commercial manufacturing of autologous and allogeneic ex-vivo gene therapies and cell therapies catering to a growing patient population. We explore isolator solutions for closing off open manipulations, end-end processing for autologous therapies, cell culture, and formulation scale-up options for allogeneic products, and robotic automation of labor-intensive unit operations.
For more information, visit the INTERPHEX website.