Core services

Connell and O’Reilly Families Cell Manipulation Core Facility (Dana-Farber Cancer Institute)

The Connell O’Reilly Cell Manipulation Core Facility assists members in developing new cell-based therapies for cancer, and supports clinical research studies designed to evaluate the safety and efficacy of these novel treatments. All cell manufacturing procedures are performed in environmentally controlled conditions according to current Good Manufacturing Practices for cell and tissue processing. Services include the processing of hematopoietic stem cells for autologous or allogeneic transplantation, generation of tumor vaccines using genetic or culture mediated modification of tumor cells, and preparation of immune cell populations for adoptive cellular therapy. The Cell Manipulation Core Facility (CMCF) Good Manufacturing

Practices (GMP) laboratory at the Dana Farber Cancer Institute (DFCI) operates under the direction of Jerome Ritz, MD (Director). The CMCF is accredited by The Joint Commission (JC) and FACT and operates a CLIA certified Quality Control testing laboratory (ID #22D1010753). The CMCF laboratory was last surveyed by JC in July 2014 and is valid for two years. The laboratory was inspected by FACT in March of 2015 for both the adult and pediatric transplant programs at DFCI as well as for both routine (361) and novel (351) cellular products. The CMCF laboratory is also FDA registered to package, process, store, label, and distribute peripheral blood stem cells, cord blood and somatic cellular products.

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Human Gene and Cell Therapy Program and Good Manufacturing Practices facility (UCLA)

The UCLA GMP facility supports investigator-initiated early phase clinical trials of cell and gene therapy product manufacture. This facility is a joint effort by the David Geffen School of Medicine, Human Gene and Cell Therapy Program (HGCTP – Donald B. Kohn, M.D., Director), the Jonson Comprehensive Cancer Center, and the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research. The GMP facility is designed for ex vivo cell manipulation of cells and gene transfer procedures, and HGCTP provides a dedicated Facility Manager and Quality Assurance Officer to maintain the facility and equipment, and provide training, oversight and support of GMP manufacturing and cGMP compliance.

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TransLab (Boston Children’s Hospital)

The TransLab is an innovative clinical and translational platform that bridges scientific discovery and clinical practice. Directed by Myriam Armant, PhD., the lab has more than ten years of experience supporting pre-clinical trial development and clinical research. More specifically, the TransLab provides an integrated process and product development platform for cell and gene therapy that delivers validated standard operating procedures (SOPs), product-specific characterization profile and acceptance criteria to ensure product safety, identity, purity and strength. In this context, the TransLab also offers regulatory support and generates the Chemistry, Manufacturing, and Controls (CMC) section of the Investigational New Drug (IND) Application. In addition, the TransLab offers a comprehensive battery of cellular and molecular assays to help guide personalized therapy or support patient monitoring. Services include simple, routine processes as well as complex and custom, non-routine laboratory developed tests. In particular one of the missions of the TransLab is to assist in developing new assays and/or transferring assays from a research laboratory context into a validated, CLIA compliant format so the assay can then be used to make clinical decisions.

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Translational Core Laboratory (Cincinnati Children’s Hospital Medical Center)

The Translational Core Laboratory (TCL), located on the CCHMC main campus, is designed and managed to support the translation of cellular and molecular research of basic science investigators through production of cellular therapy and gene therapy products for early phase clinical trials. The TCL includes: the Vector Production Facility (VPF) for scale up and production of GMP grade viral vectors; the Viral Vector Core (VVC) for production of research grade vectors; the Cell Processing and Manipulation Laboratory (CPML) and the Cell Manipulation Lab (CML) for scale up and production of more than minimally manipulated cells in compliance with GMP; Good Tissue Practice (GTP) and the Cell Processing Core (CPC) for production of research grade cell products; and the Translational Trials Development and Support Laboratory (TTDSL), a laboratory certified by the College of American Pathologists as meeting Clinical Laboratory Improvement Act regulations (CAP/CLIA) that provides molecular and cellular assay support for diagnostics, and research and clinical trial testing and preclinical in-vitro safety assays.

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