MedStart: Optimizing Cell and Gene Therapy Manufacturing

The Sacramento Region is home to a vibrant medical startup ecosystem. To support its growth, MedStart, is a program dedicated to fostering innovation in medical and life sciences.

This month, Mary Ann F. Santos, Thermo Fisher Scientific Senior Manager, Strategic Collaborations and Sarah Daoudi and Kevin Pridham, Field Applications Scientists for Cell and Gene Therapy and Genome Engineering will be discussing process optimization for efficient cell and gene therapy manufacturing.

Cell and gene therapy is transforming the treatment of diseases by providing a targeted approach that has led to prolonged success for many patients. With a growing number of therapies in development, manufacturers are seeking ways to enhance and scale up the manufacturing process to meet regulatory standards and reduce costs. 

For cell therapies, one strategy to overcome current manufacturing challenges is utilizing automated, closed systems with integrated software controls. The same can apply for streamlining gene therapies and utilizing optimized systems that allow for seamless scale-up of viral production. For the manufacture of cell therapies requiring gene modification, access to GMP-grade nucleases & reagents that can meet your clinical needs and required regulatory standards is also critical.  

These systems offer advantages over traditional open systems, such as standardized processes, cost savings, consistent production results, and reduced contamination risks. This presentation will highlight some of the current challenges in cell and gene therapy manufacturing, highlighting the benefits of new closed, automated, and modular technologies in facilitating both end-to-end viral and non-viral processes. Additionally, we will explore the development of a High Fidelity GMP Cas9 protein that can be implemented within these closed, automated, and modular cell manufacturing systems.

MedStart is supported by ReadyStart Cleanroom, Carlsen Center for Innovation and Entrepreneurship, the 50 Economic Alliance, and Startup Folsom.

Please note that this event is in-person at the ReadyStart CleanRooms.