NewYork-Presbyterian/Weill Cornell Cellular Therapy Facility
The Weill Cornell Cellular Therapy Facility (CTF) is a cellular processing laboratory that provides hematopoietic stem cells (HSCs) and other hematopoietic and non-hematopoietic cell types for patient therapy. Cells for hematopoietic reconstitution are derived from bone marrow, peripheral blood, and umbilical cord blood (UCB), while novel somatic cellular therapies are obtained from various tissues.
The state-of-the-art, 3600-square-foot facility located on the ground floor of the M building of NewYork-Presbyterian Hospital’s Weill Cornell Campus was built in 2009. The lab contains 3 processing rooms, a state-of-the-art cryofacility within the lab, three biological safety cabinets, two Miltenyi CliniMACS, a Sysmex XE5000 Hematology analyzer, and two BD FACSCanto II flow cytometers, where in-house flow cytometry is performed. The laboratory operates from 8 am to 6 pm, 5 days per week. The laboratory is staffed with highly-skilled and specialized medical laboratory scientists, researchers, quality specialists, support staff, and administrative and medical leaders. The medical director of the laboratory is Dr. Ljiljana Vasovic, the laboratory manager is Denden Benabdessadek, and the laboratory supervisor is Kareem Brown.
The laboratory processes over 500 cellular products annually, including autologous, allogeneic-related and allogeneic-unrelated peripheral blood stem cells, umbilical cord blood, bone marrow, and other cellular therapy products annually in support of the Weill Cornell Blood and Marrow Transplant Program. The laboratory maintains accreditation with Foundation for the Accreditation of Cellular Therapy, the College of American Pathologists, the National Marrow Donor Program, and complies with FDA and New York State regulations.
Investigational Cellular Therapy Laboratory (ICT)
The Investigational Cellular Therapy Laboratory at NewYork-Presbyterian Hospital is a 400 square foot hepa-filtered, ISO 7 (class 10,000) positive pressure lab within the Cellular Therapy Facility. The design of the ICT supports unidirectional personnel and material flow and contains a separate gowning area. The ICT lab contains two biological safety cabinets and a Miltenyi Prodigy for cell selection, transfection and expansion.
The ICT focuses on Phase I clinical trials of more than minimally manipulated products that are manufactured in closed systems, including CAR T cells and virus-specific T cells.
The laboratory has an experienced team to work with customers on implementing new clinical cellular therapy products, including all aspects of cellular therapy product manufacturing:
- Process development, qualification, and validation
- Product Manufacturing
- Control of critical systems
- Operations and materials management
- Equipment management
- Business plan development and project management
- Project budget development
- Document change control
- Quality and compliance
- Clinical Trials management
FDA regulatory requirements necessitate that investigational, more than minimally manipulated products be produced in accordance with current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP). Our comprehensive quality process, composed of a cGMP/cGTP based Quality Assurance Program, Product Development Process, and Risk Management, assures the safe and effective manufacturing of cellular therapy products.
The ICT team consists of two medical directors, Dr. Ljiljana Vasovic and Dr. Melissa Cushing, the laboratory manager and laboratory supervisor, two laboratory research techs, and a quality project lead.
The mission of the lab is to translate basic science cellular therapy constructs into clinical products that can be evaluated in early-stage clinical trials. The laboratory is an excellent resource for investigators from Weill Cornell Medicine and other academic facilities, as well as commercial firms, such as start-up biotherapeutic firms, that need development services, quality management, and regulatory services for testing novel biological therapeutic products.
Contact laboratory leadership to inquire about clinical or research collaborations, prior to the submission of a new Institutional Review Board (IRB) application at the email address below.
NYP/WC CTF and ICT Lab:
530 East 70th Street
Ground floor, M Building
New York, NY 10065
Email: Cellular Therapy Laboratory Trials <CTLabTrial@nyp.org>