The Cell Therapy Manufacturing Facility (CTMF) at MedStar Georgetown University Hospital was founded by consolidating the previous Islet Cell Laboratory and Cellular Engineering Laboratory in May of 2016. The CTMF is registered with the FDA in accordance with 21 CFR part 1271. This facility works closely with MedStar Georgetown clinical human islet transplant program, bone marrow collection program (BMCP), and bone marrow and stem cell transplant program (BMSCTP).

The CTMF is comprised of five laboratory subsections that are,  a class 10, 000 (ISO 7) clean room, quality control, cell processing, cryogenics, and a flow cytometry laboratory.

The CTMF quality control laboratory performs requisite testing for cell therapy products.

The CTMF cell processing laboratory supports the Bone Marrow Collection Program (BMCP), the National Marrow Donor Program under the BMCP, and the Bone Marrow and Stem Cell Transplant Programs at MGUH.

The CTMF Cryogenics Laboratory ensures long-term storage of cryopreserved HPC clinical products.

Flow Cytometry Lab in the CTMF provides the clinical programs and in-house manufacturing process with analytic testing services.

The CTMF IT is staffed with dedicated personnel who undergo continuous training, proficiency testing and competency review.  A Quality Assurance program is in place to monitor and verify compliance with regulations and to ensure consistent product quality.

Accreditation

The CTMF is registered with the FDA in accordance with 21 CFR part 1271 and operates under the current Good Manufacturing Practices (cGMP). The CTMF is accredited by the College of American Pathologists (CAP), the AABB (Formerly the American Association of Blood Banks), and CLIA certified. CTM has been awarded FACT (Foundation for the Accreditation of Cellular Therapy) accreditation on January 10, 2018.

Our Mission

Our mission is to use our expertise for manufacturing and to support the development, the processing, and packaging of safe, high quality human cell-based clinical products and services for early translational research, clinical trials and therapeutic use of pancreatic islets and hematopoietic progenitor cells for the MedStar Georgetown human islet transplantation and bone marrow and stem cell transplant programs.

Our Vision

Facilitate the CTMF successful drive in the development of cell therapy products and services from laboratory to bedside.

Provide superior quality products and services for life science research and clinical applications, improving human health.

Create a self-improvement opportunity for all staff members by offering continuous training and retraining to fulfill growing cell manufacturing needs.

MedStar Georgetown In the News 

MedStar Georgetown Awarded Another International Accreditation for Stem Cell and Bone Marrow Transplantation

FACT Gold Seal

 

 

Product Manufactured

Human Pancreatic Islets

  • Pancreas from the chronic pancreatitis patient
  • Cadaveric donor pancreas

Hematopoietic Progenitor Cells

  • Bone marrow
  • Peripheral blood stem cells
  • Donor lymphocytes

Human Hepatocytes (Research)

  • Surgical liver explant

Human Amniotic Epithelial Cells (Research)

  • Placenta from normal delivery