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
Date: November 13, 2024
Time: 6 pm - 8 pm
Cost: Free
Register: Eventbrite
About Mary Ann Santos
Mary Ann Santos is a Global Cell and Gene Therapy Senior Manager, Cell, Gene and Advanced Therapies Strategic Collaborations at
Thermo Fisher Scientific. She has over 27 years of experience in the biotechnology industry with expertise in Cell Biology and Life Sciences. This
includes working with biotechnology, bioindustrial and biopharmaceutical companies in addition to academic institutions in North America and across the globe. She has also led research project teams with a focus in next generation cancer therapeutics as well as experience in Process Development prior to joining Thermo Fisher Scientific.
About
Sarah Daoudi
Sarah Daoudi is a Field Application Scientist that provides solutions and consultation for Thermo Fisher Scientific’s cell and gene therapy workflows and Gibco Cell Therapy Systems (CTS) brand of products. Sarah has expertise in cell therapy workflows including CAR-T workflows, manufacturing, viral vector production (lentivirus and adeno-associated viruses), and drug development. Formerly a R&D scientist at Thermo Fisher Scientific, she helped launch the CTS Rotea System by producing application data, writing and developing new protocols, as well as extensive troubleshooting and customer support. In her previous role as Process Development Research Associate at City of Hope (Duarte, California), Sarah oversaw and worked on improving, troubleshooting, and development of Phase I CAR-T cell therapeutic drugs and workflows for over ten different IRBs. Sarah received her master’s degree in Cell and Molecular Biology from California State University, Fullerton (California).
About Kevin Pridham
Kevin Pridham is a Field Applications Scientist at Thermo Fisher Scientific supporting the Gene Modulation & Editing and Advanced Cancer Cell models portfolios, consisting of CRISPR/Cas, RNAi, disease modeling, delivery, and cancer tumoroid culture across North America. Kevin has been with the company since 2022. Prior to joining Thermo Fisher Scientific, Kevin obtained his PhD from Virginia Tech in Translational Biology, Medicine, & Health. He has over 15 years of research experience in cancer biology, drug development, drug delivery, and neurobiology.