The Cutting Edge of Cell and Gene Therapy: Inside Roswell Park’s GMP Engineering and Cell Manufacturing Facility (GEM) With Christopher Choi, MD

A New Era in Cell Therapy Manufacturing

Dr. Choi, who has over 20 years of experience in GMP manufacturing and cell therapy, provides an overview of the facility’s capabilities.

“One of the bottlenecks for academics is taking an idea from concept to an actual product that can be used in clinical trials and eventually become commercially viable. That’s something we can help with,” he explains.

The facility’s 20 clean rooms ensure regulatory compliance with FDA mandates and allow multiple clinical trials to be conducted simultaneously. This infrastructure not only benefits Roswell Park’s internal research but also extends its expertise to industry partners.

Cutting-Edge Equipment and Services

The expansion brings state-of-the-art technology and unparalleled service capabilities. “For an academic institution to have a facility that meets industry rigors is unique,” Dr. Choi noted.

The GEM offers advanced manufacturing processes for a wide array of cell therapy trials, including chimeric antigen receptor (CAR) T-cell therapies, engineered T-cell receptor (TCR) therapies, and dendritic cell vaccines. These resources provide a seamless transition from research to clinical application, a challenge that has historically limited the development of novel therapies.

Bridging the Gap Between Research and Patient Care

One of the biggest hurdles in therapeutic development is the complexity of moving a concept from the lab to patient treatment. “The FDA requires very specific processes, and many early investigators may not have experience in navigating these regulations. We provide that expertise to ensure efficiency and cost-effectiveness,” Dr. Choi explained.

Unlike traditional manufacturing setups, which require collaboration with multiple external partners, Roswell Park’s facility integrates key capabilities—including gene editing, viral vector production, and advanced testing—under one roof. This integrated approach significantly accelerates the development timeline and reduces costs, making novel therapies more accessible.

Overcoming Funding and Production Constraints

Cost and production limitations are critical challenges in cell therapy development. “Because we’re an academic institution, we can offer a more cost-effective solution compared to commercial CMOs (contract manufacturing organizations),” Dr. Choi emphasized.

By leveraging in-house expertise and resources, the facility reduces the need for external contracts, streamlining both research and clinical applications. The facility is also uniquely positioned to not only manufacture these advanced therapies but also conduct clinical trials and long-term patient monitoring, ensuring comprehensive care.

Implications for the Community Oncology Setting

For community oncologists, Roswell Park’s new GMP facility offers opportunities to expand treatment options for their patients. “Our goal is to have a cell therapy or CAR T therapy for every indication. If you have a patient with limited options, reach out to us to see if they qualify for a trial,” Dr. Choi encouraged.

Moreover, the facility can manufacture and ship cell therapy products to hospitals nationwide, ensuring that community oncologists and their patients have access to the latest advancements in cancer treatment.

For patients, this development brings renewed hope. “We have world experts right here who have worked on multiple commercial CAR T products. If you’re exploring clinical trials, call Roswell Park to see what we have to offer,” Dr. Choi advised.

Looking Ahead: The Future of Cell and Gene Therapy

Roswell Park is actively engaged in pioneering clinical trials for CAR T therapies, engineered TCR therapies, and dendritic cell–based treatments. With leading scientists like Dr. Marco Davila and Dr. Renier Brentjens at the forefront of CAR T research, the institution is positioned to drive major breakthroughs in cancer treatment.

Conclusion

As Roswell Park continues its mission to advance therapeutic development, this new GMP facility stands as a beacon of innovation, ensuring that the next generation of cancer treatments reaches patients faster and more effectively than ever before.

About the Speaker

Christopher Choi, MD, is an Associate Professor of Oncology and the Senior Vice President of Industry Partnerships at Roswell Park Comprehensive Cancer Center in Buffalo, New York, where he is also the Technical Director of the Good Manufacturing Practices (GMP) Cell Engineering and Manufacturing Facility. He has more than 20 years of experiences in cell and gene therapy manufacturing, business operations, and quality and process development.