Dana Farber Cancer Institute - Connell & O'Reilly Families Cell Manufacturing Core Facility
directed by Jerome Ritz, MD
a member since 3/11/2013

Contact Info

For information contact
Olive J. Sturtevant.

617 632-3381
Dana-Farber Cancer Institute
450 Brookline Ave
JF313
Boston, Mass 02215

USA
617 632-5759

Services Provided

This facility provides research grade material and offers production support to both Academics and Companies.

Misc Services

  • regulatory affairs
  • compliance
  • translational

Biologics Produced

  • working cell banks
  • Tumor Vaccines
  • mesenchymal stromal cells
  • Isolated and Expanded T-Cells
  • Hematopoietic Progenitor Cells
  • Hematopoietic Cell Isolations
  • Gene-modified T-Cells
  • full GMP facility. Master cell banks
  • Antigen Specific T-cells
  • Peptide Loaded Dendritic Cell Tumor Vaccines

Notable Affiliations

PACT

About this facility

The Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) at the Dana-Farber Cancer Institute (DFCI) is located in the Jimmy Fund Building-3 (JF-3).  The CMCF laboratory at Dana-Farber is fully equipped for processing and cryopreservation of hematopoietic progenitor and other therapeutic cells as well as providing processing for other cellular products. Aside from routine cellular processing (PHS Act 361 Products) the laboratory also manufactures products under INDs and IDEs (PHS Act 351 Products).  The CMCF laboratory at the DFCI operates under the direction of Jerome Ritz, MD (Laboratory Director) and Grace Kao, MD (Assistant Medical Director).   The CMCF and their processes have been designed to meet the current good manufacturing practice (cGMP) and current Good Tissue Practice (cGTP) for hematopoietic cell and other cell processing as required by the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), The Joint Commission and the Foundation for the Accreditation of Cell Therapy (FACT). Standard procedures have been implemented to ensure the consistent quality and integrity of the products manufactured. The laboratory has adequate space for the orderly placement of equipment and materials within the facility and to ensure that only one product is processed in a given work space at a time.  There is adequate lighting and the facility is maintained in a sanitary and good state of repair at all times.  The manufacturing facility is classified as an ISO 7 cleanroom. Appropriate process and environmental controls are in place to ensure the facility operates well within the guidelines for an ISO Class 7 clean room. All cellular product storage equipment is maintained on a continuously monitored Rees alarm system. Backup storage is available should it be necessary to transfer products.  In case of an emergency, the assistant medical director is on call 24 hours a day for consultation.  

The CMCF is accredited by The Joint Commission (JC) and FACT and is CLIA certified (ID #22D1010753).  The CMCF laboratory was last surveyed by JC in August 2012  The laboratory was inspected by FACT in 2012 and received a three year accreditation as the cell processing laboratory for both the adult and pediatric transplant programs at DFCI.  The CMCF laboratory is also FDA registered to package, process, store, label, and distribute peripheral blood stem cells, cord blood and somatic cellular products.  The FDA registration number the CMCF is FEI 3003934255