The OSUCCC – James and the W.W. Williams Company Cell Therapy Laboratory (CTL) are turning cancer discoveries into treatments. The experts within the state-of-the-art, 2,500-square-foot facility produce clinical-grade living cells for use in blood and marrow transplants, immunotherapy clinical trials and therapies, and regenerative medicine clinical trials.
The OSUCCC – James Cellular Therapy Lab is led by Director Lynn O’Donnell, PhD, an associate professor in the Division of Hematology.
The lab’s goal? To bring novel cellular therapies to patients. The Cellular Therapy Lab also helps physician-scientists at the OSUCCC – James conduct phase I and phase II clinical trials to evaluate cellular immune therapies that are based on preclinical and clinical research.
Lab highlights include:
- Dedicated, highly trained cellular therapy associates
- Two ISO Class 7 clean rooms
- A quality control lab to test cell therapy products for safety, purity and potency, as required by the FDA
- Cryopreservation and storage equipment that enables the lab to store patients’ samples and products for 10 years or longer
- Highly 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 infusion-preparation
- Expertly trained associates who perform and maintain extensive, detailed records of cleaning and sanitization, environmental monitoring, batch production, materials management and process-validation
The U.S. Food and Drug Administration (FDA) regulates the Cell Therapy Lab in two ways:
- As a manufacturer of cells, requiring the lab to register with the FDA and to list any “un-manipulated cells” that are processed; and
- As a drug and biologic manufacturer for cells that are heavily manipulated through expansion, activation or genetic modification.
Before infusing manipulated cells into patients, the lab 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.
The Cell Therapy Lab has 10 distinct rooms or spaces that are designed to help lab experts meet and exceed both the FDA’s Good Manufacturing Practices for drugs and biologics and Good Tissue Practices for un-manipulated cell therapies.
If you’ve been diagnosed with cancer, would like a second opinion or would like to speak with a cancer specialist about immunotherapy options, please call The James Line at 800-293-5066 or 614-293-5066 to make an appointment. Specialized cell therapy coordinators are also available to answer questions at 614-688-7868.