The (Connell and O'Reilly Families) Cell Manipulation Core Facility (CMCF)
The (Connell and O'Reilly Families) Cell Manipulation Core Facility (CMCF), at Dana-Farber Cancer Institute (DFCI) was created in 1996 to be a manufacturing facility for production of safe and effective novel cellular component therapies, that meet regulatory guidelines for clinical use and enable cellular therapies to be translated from the bench to bedside. The goal of this facility is to assist DF/HCC investigators and sponsors in developing new cell-based therapies for cancer, gene therapy products for genetic diseases, and adoptive immunotherapy products. Many of these cellular products are manufactured in the context of clinical research studies designed to evaluate the toxicity and efficacy of novel treatments.
The CMCF facility, located in the Jimmy fund building, is dedicated to the production of clinical-grade cellular therapy products for patients who participate in clinical trials conducted by DF/HCC investigators. All procedures are performed in environmentally-controlled conditions according to current Good Manufacturing Practices (cGMP) established for cell and tissue processing. The third floor accommodates all of the production clean room areas while space on the ground floor is devoted to the storage of cellular products, tissues, and blood and tumor samples in liquid nitrogen and mechanical freezers. In addition, the Pasquarello Tissue Repository, located on the 6th floor, collects and stores patient samples solely for research use.
The CMCF is available to both clinical and laboratory investigators at all DF/HCC institutions and will provide services to patients at all DF/HCC affiliated hospitals. The staff of the CMCF are committed to working with DF/HCC investigators at all levels of clinical trial development and execution. In addition to manufacture of clinical grade cellular therapy products, CMCF services include pre-clinical development of manufacturing procedures, facilitation of DF/HCC and FDA review, data management, in-process and release testing of products, quality control monitoring, coordination of internal and external audits, and generation of reports for publication. The CMCF has been accredited by the Foundation for the Accreditation of Cellular Therapy (FACT), and is licensed by CLIA to perform high-complexity testing. The CMCF supports the Cancer Vaccine Center at DFCI, the Center for Human Cell Therapy at Boston Children’s Hospital and is also a member of the Joint Program in Transfusion Medicine.
Director: Jerome Ritz, MD
Assistant Medical Director / Clinical Instructor: Sarah Nikiforow MD, PhD
Technical Director: Darlys Schott, BS, MT (ASCP), SBB
Director of Quality Assurance, Cellular Therapies: Olive Sturtevant, BA, MT (ASCP) , SBB, SLS, MHP
Quality Assurance Manager: Mary Ann Kelley, BS, MT (ASCP)
System Manager: Philip Brzezinski, BS, MBA
Supervisor, Novel Cellular Therapies Lab: Heather Daley, BS
Supervisor, Stem Cell Therapies Lab: Karl Stasko, BS, MPH
Supervisor, Quality Control Lab: Sharon Anderson, BS, MS
Supervisor, Pasquarello Tissue Lab: Doreen Hearsey, BS
Program Administrator: Gerry MacDonald
- Establishment of antitumor memory in humans using in vitro-educated CD8+ T cells. [View on PubMed.gov]
- Prostaglandin-modulated umbilical cord blood hematopoietic stem cell transplantation. [View on PubMed.gov]
- Validation of short-term handling and storage conditions for marrow and peripheral blood stem cell products. [View on PubMed.gov]
- Immune reconstitution after double umbilical cord blood stem cell transplantation: comparison with unrelated peripheral blood stem cell transplantation. [View on PubMed.gov]
PUBLICATION ACKNOWLEDGEMENT: If research supported by this core facility results in publication, please acknowledge this support by including the following in your publication(s):
We thank Dana-Farber/Harvard Cancer Center in Boston, MA, for the use of the Cell Manipulation Core, which provided __________ service. Dana-Farber/Harvard Cancer Center is supported in part by a NCI Cancer Center Support Grant # NIH 5 P30 CA06516.