The W.W. Williams Company Cell Therapy Laboratory (CTL) at the OSUCCC – James is a 2,500-square-foot, state-of-the-art facility that produces clinical-grade living cells for use in blood and marrow transplants, in immune therapy clinical trials and therapies, and also in regenerative medicine clinical trials.
The CTL is regulated by the U.S. Food and Drug Administration (FDA) in two ways:
- As a manufacturer of cells, which requires the CTL to register with the FDA and list any “un-manipulated cells” that are processed;
- As a drug and biologic manufacturer for cells that are heavily manipulated through expansion, activation or genetic modification
Before infusing manipulated cells in to patients, the CTL must request the FDA’s permission by submitting an Investigational New Drug application that details the preclinical studies, the planned clinical trial and the manufacturing process. To meet the increased demand and regulatory oversight, the OSUCCC – James expanded the CTL in 2014 with the opening of the new James Cancer Hospital and Solove Research Institute.
The CTL has 10 distinct rooms or spaces that are designed to help them meet both the FDA’s Good Manufacturing Practices for drugs and biologics, and Good Tissue Practices for un-manipulated cell therapies.
Highlights of the CTL include:
- Dedicated, highly trained staff members;
- Two ISO Class 7 clean rooms that dramatically reduce the risk of contaminating patient’s cell therapies;
- A quality control lab equipped for testing cell therapy products for safety, purity and potency, as required by the FDA;
- Cryopreservation and storage equipment that enables the CTL to store patients’ products for 10 years or longer;
- Specialized cell-processing equipment, including cell-selection devices, automated cell processors and bioreactors such as the CliniMACS Prodigy – an automated, self-contained system for cell selection, culture and preparation for infusion.
- In addition to the CTL facility, the staff performs and maintains extensive records of cleaning and sanitization, environmental monitoring, batch production, materials management and process-validation.
The primary focus of the CTL is research with the goal of bringing novel cell therapy products to patients. The CTL helps physician-scientists at the OSUCCC – James conduct phase I and phase II clinical trials to evaluate cellular immune therapies that are based on the scientists’ own preclinical research.
Lynn O’Donnell, PhD, is the director of the CTL and is an associate professor in the OSUCCC – James Division of Hematology.