Assistant Professor of Clinical Laboratory Medicine
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.
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 Laboratory
Advanced Cell Therapy Faculty
Professor of Laboratory Medicine, of Cell Biology and of Pathology; Assoc. Director, Yale Stem Cell Center; Assoc. Director, Transfusion Medicine Service; Medical Director, Clinical Cell Processing Laboratory; Medical Director, Advanced Cell Therapy Laboratory
Diane Krause MD, PhD is Professor of Laboratory Medicine, Pathology and Cell Biology at Yale University; Associate Director of the Yale Stem Cell Center; and Director of the Clinical Cell Processing Laboratory. She received an Sc.B. degree in Biology from Brown University, and an MD and PhD degree from the University of Pennsylvania. After completing a residency in Clinical Pathology at the University of Pennsylvania, she performed post-doctoral studies at Johns Hopkins University. She runs a well-funded research laboratory focused on leukemogenesis, stem cells, clinical cell therapy and pluripotent stem cell differentiation down the parathryoid lineage.