Experimental Cellular Therapy
Experimental Cellular Therapy within the Weill Cornell/NewYork-Presbyterian Department of Pathology and Laboratory Medicine supports the translation of cellular therapy concepts into early-stage clinical products-spanning clinical processing, investigational handling, and experimental manufacturing.
- Clinical processing for hematopoietic and cellular therapy products
- Investigational trial support for externally manufactured products
- Phase I experimental manufacturing in closed systems (e.g., CAR T)
Cellular Biotherapies Laboratory Division
CCTL 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.
Processes 500+ cellular products annually in support of the Weill Cornell Blood and Marrow Transplant Program.
ICTL shares space and resources with CCTL, but focuses on clinical trials where patient/donor cells are collected and shipped for further manufacturing at an outside facility, then received and handled on return as investigational products.
Staff collaborate with investigators to assess protocol feasibility and budgeting for requested processing services.
Cellular Therapy and Experimental Manufacturing
The CTEM Service is currently located in a 400 sq ft HEPA-filtered, ISO 7 positive pressure cell manufacturing space within the CBLD facility. The cleanroom design supports unidirectional personnel and material flow, with a dedicated gowning area.
Supports Phase I clinical trials of more-than-minimally manipulated products manufactured in closed systems, including CAR T and other immune effector cells (IECs).
CTEM partners with investigators and sponsors across the full lifecycle of a cellular therapy program.
Facilities & operations
A state-of-the-art 3,600 sq ft facility on the ground floor of the M Building at NewYork-Presbyterian Hospital's Weill Cornell Campus (built in 2009).
Three processing rooms, an in-lab cryofacility, biological safety cabinets, two Miltenyi CliniMACS, hematology analyzer, and in-house flow cytometry.
Operating hours are 8:00 am-6:00 pm, five days per week, staffed by specialized medical laboratory scientists, researchers, quality specialists, and leadership.
The laboratory processes over 500 cellular products annually across autologous and allogeneic workflows, supporting the Weill Cornell Blood and Marrow Transplant Program.
Quality, compliance, and regulatory alignment
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). CTEM uses a comprehensive quality process composed of a cGMP/cGTP-based Quality Assurance Program, Product Development Process, and Risk Management to support safe and effective manufacturing of cellular therapy products.
The laboratory maintains accreditation and compliance with major standards and regulations.
Engage with Experimental Cellular Therapy
M Building (CBLD facility)
Contact laboratory leadership to discuss clinical or research collaborations prior to submitting a new IRB application.
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