Advanced Cell Therapy (ACT) Laboratory

The Yale Advanced Cell Therapy (ACT) laboratory is a GMP (Good Manufacturing Practices) laboratory designed for the production of high quality, safe, cell products for clinical treatment. The ACT is dedicated to and responsible for the production of cellular products to be used in phase I/II clinical trials conducted by investigators at Yale and in multicenter trials. Our laboratory has significant experience with IND-enabling studies using GMP. Cell product safety and quality are the top priorities for our GMP laboratory. By executing and documenting Good Manufacturing Practices (GMPs), the ACT practices assure that all government regulations are met, and that all products meet defined release criteria and are safe for administration to human subjects.

Chemistry, Manufacturing and Controls (CMC)

All steps of GMP manufacturing, cryopreservation and qualification of cells for clinical research (CCR) are controlled by Standard Operating Procedures (SOPs), overseen by QA/QC and performed in our GMP facility by qualified personnel. CCR are isolated, expanded, tested, certified and released using validated SOPs. All SOPs for cell processing and transport to the patient are established and validated. SOPs governing the chain of custody, the certificate of analysis, immediate release criteria, and post-administration safety testing are also in place.

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Overview of the GMP Facility

To support clinical investigation in the field of cellular therapy the ACT Laboratory is located directly adjacent to the Transfusion Medicine Division and the Clinical Blood Bank for Yale New Haven Hospital.

Advanced Cell Therapy Faculty

Diane Krause, MD, PhD

Diane Krause MD, PhD is Professor of Laboratory Medicine, Pathology and Cell Biology at Yale...