The OSUCCC – James is at the forefront of discovering and implementing new uses for cellular therapy, which is changing the way we, and those around the world, treat certain cancers.
When it comes to offering groundbreaking CAR T-cell therapy, Natural Killer (NK) cells and other cellular therapies here at The James, the W.W. Williams Company Cell Therapy Laboratory (CTL) is an integral part of this lifesaving process.
This state-of-the-art facility is 2,500 square feet and is filled with the most advanced tools that allow our cancer experts to not only provide treatments, like blood and marrow transplants and CAR T-cell therapy, but also participate in clinical trials in the revolutionizing areas of immunotherapy and regenerative medicine.
What we do at the cell therapy laboratory
In the cell therapy laboratory at the OSUCCC – James, our dedicated cancer researchers produce clinical-grade living cells for use in immunotherapy research and other related clinical trials.
This is in addition to preparing bone marrow and stem cells, as well as CAR T-cells, for transplant and providing lifesaving treatments for those with cancer. For example, the OSUCCC – James uses CAR-T cells to treat people who have acute lymphoblastic leukemia, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and aggressive follicular lymphoma, in addition to multiple myeloma.
This lab helps physician-scientists at the OSUCCC – James conduct phase I and phase II clinical trials to evaluate cellular immunotherapies that are based on preclinical and clinical research. The work we do in this space allows us to bring more novel cellular therapies to our patients and others worldwide who have these cancers.
The OSUCCC – James Cellular Therapy Lab is led by Director Lynn O’Donnell, PhD, an associate professor in the Division of Hematology.
Highlights of the cellular therapy lab
Provide this groundbreaking work and research requires a special place and a team of experts, working around the clock. Here are some of the highlights of the OSUCCC – James Cellular Therapy Lab:
- Expertly trained associates who perform and maintain extensive, detailed records of cleaning and sanitization, environmental monitoring, batch production, materials management and process-validation
- Two ISO Class 7 clean rooms
- A quality control lab to test cell therapy products for safety, purity and potency, as required by the U.S. Food and Drug Administration 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
Cell therapy lab regulations
The (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.
The laboratory is also accredited by the Foundation of Cellular Therapy.
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.