Meet the expert - Innovative Closed Process CAR-T Cell Therapy Platform

[Meet the Expert] Innovative Closed Process CAR-T Cell Therapy Platform

Current manufacturing processes for CAR-T present challenges in purification, yield, expansion and quality control. Dr Poonam Sharma talks through some of the ways Wuxi Advanced Therapies are solving this today 
In this session Dr Sharma share's Wuxi's innovative closed process CAR-T cell therapy platform. Wuxi's US site comprises four buildings and over 400,000 square feet for cell and gene therapy, clinical/commercial manufacturing and testing services, located in the Navy Yard in Philadelphia.
 

 

Wuxi App Tec's experience in manufacturing CAR-T cells originates in 2014 with now over 400 released GMP lots including both autologous and allogeneic therapeutics. 

The platform provides advanced therapy companies with integrated capabilities for CAR-T production, including: in-stock raw materials with established batch records; regulatory and technical expertise; process and analytical development; full in-process and release testing; robust quality control and quality assurance oversight; and access to facilities that offer the capacity and flexibility to meet companies' timeline needs. Using a list of pre-evaluated equipment, technologies and materials with developed closed processes for different unit operations – an innovation that will increase the speed in getting new cell and gene therapies to market.

Questions 

How much flexibility does the platform offer? And how does my customization impact the timeline?

Our process platform accelerates clients timelines, there's flexibility within the platform and changes normally result in time and cost. Our platforms for manufacturing and testing can save a considerable amount of time and to getting to GMP. However, we will work with you to make sure that you're satisfied how with how your process has been integrated with into our platform.

Is your platform able to be applied to other technologies?

Given our experience and past success, we're confident that this platform this closed CAR-T platform will be successful. We have experience in both autologous and allogeneic cell therapies with over 400 release GMP lots So I think with to answer your question specifically, this platform can be is pretty versatile and can be used for multiple different technologies.