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Working together to build the Advanced Cell Therapy Lab at UC San Diego

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Case Study

The Advanced Cell Therapy Lab (ACTL) was established in 2016 at UC San Diego Health with leadership gift funding from Ralph and Fernanda Whitworth (Immunotherapy Foundation) and Denny Sanford.The ACTL was created to aid in the transition from research and development to provide clinically relevant manufacture of cell therapy for investigational new drugenabling studies of Phase I/II clinical trials and to advance the capabilities of Moores Cancer Center’s Immunotherapy program.

The ACTL is a state-of-the-art cell manufacturing lab, capable of relaying new levels of specificity in understanding an individuals’ unique immune system and antigen production. In 2017, the lab was operationalized for regulatory approval to treat patients with next-generation cell therapies across multiple cancer types.In addition to being a resource for both UCSD investigators and collaborating biotech companies in San Diego and beyond, the facility has helped support UC San Diego Health’s development of a robust clinical trial portfolio.

Dr. Dan Kaufman, who leads the ACTL as Scientific and Medical Director notes, "The ACTL provides a key resource for both UCSD and local investigators to move novel cell therapy projects from the lab into clinical trials here at UCSD. Without this facility, UCSD would not be able to provide leading-edge care for cancer patients. These cell therapies are only going to grow in numbers and efficacy in the future."

ACTL capabilities include:

  • Optimizing manufacturing processes, including scale-up, closed systems and delivery formats
  • Development of Standard Operating Procedures and Batch Production Records
  • Cell product manufacturing, including cell enrichment with the CliniMACS System
  • Optimizing manufacturing processes, including scale-up, closed systems and delivery formats
  • Cell product characterization, including standard microbiological release assays, flow cytometry and RT-qPCR assessment
  • Secure storage of cell banks and cell products
  • Material risk assessment and selection
  • Writing or review of CMC or supporting reports

“The ACTL is ground zero for all cell therapy at UC San Diego,” said Dr. Ezra Cohen, a leading physician-scientist in immuno-oncology who also helms several of UC San Diego Health’s most promising clinical trials, including the Tumor Infiltration Therapy trial and a first-in-class personalized cancer vaccine trial, also made possible through grant-funding from Immunotherapy Foundation. Cohen was recruited from the University of Chicago to help build the Immunotherapy Program at UC San Diego Health and worked in partnership with the cancer center’s leaders and Ralph Whitworth to bring this exceptional facility into existence.

“Ralph wanted something that would move the needle and would have long-lasting influence in the advancement of immunotherapies and novel approaches to create better options for patients in the future,” said Cohen.

For more detailed information on the Advanced Cell Therapy Lab at UC San Diego Health, please visit the facility’s website here.

Immunotherapy Foundation founder Ralph Whitworth and co-lead physician/researcher Dr. Ezra Cohen in the state-of-the-art cell processing center at UCSD.

Advanced Cell Therapy Lab at UC San Diego Health

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EXPLORATION

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ACCELERATION

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COLLABORATION

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CURES