Roswell Park GMP Engineering & Cell Manufacturing Facility
Delivering the Next Generation of Cell & Gene Therapy.
From Ideation to First in Human
We invite you to transition your novel therapy concept into a tangible treatment poised for early phase clinical trials. Leveraging the unparalleled expertise of the Roswell Park GMP Engineering & Cell Manufacturing Facility (GEM), we offer secure production facilities and proven processes to seamlessly align the critical components of your project.
Roswell Park serves as your all-encompassing solution for the entire lifecycle of your discovery, development, and clinical trials. Our focus is on fast-tracking your R&D pipeline to meet the escalating demand in the industry.
Let’s initiate a conversation to explore how we can collaborate and expedite the progression of your therapeutic innovation.
Capabilities for Your Project
Clinical manufacturing, viral vector production, CAR (Chimeric Antigen Receptor) T-Cell production, and process development.
Why Choose Roswell Park GEM?
End-to-end-services: Preclinical to clinical trials, immune analysis, deep research expertise, and knowledgeable quality assurance.
State-of-the-Art Facilities
Sophisticated instrumentation, cutting-edge technical and analytical platforms, comprehensive sample biorepositories, and more.
People: Multi-Phase Leaders
The GEM team brings extensive industry experience across all clinical manufacturing phases. Through them, GEM clients can call on the deep bench of Roswell Park physicians, scientists, and technicians.
Fully Integrated CDMO
Place your trust in the Roswell Park GMP Engineering & Cell Manufacturing Facility's (GEM) cutting-edge clean rooms, cell therapy equipment, manufacturing know-how, robust capabilities and comprehensive suite of quality assurance and control procedures. This infrastructure is grounded in Roswell Park's impressive 125-year legacy of innovation. Choose to bring your project to our well-established, and continuously expanding facility to benefit from the speed, quality, and technical expertise offered by our GEM team. Partner with us for a collaboration that leverages our state-of-the-art facilities and rich history of innovation.
Our Facility Attracts $30M Investment from State
Introducing the expanding Roswell Park GMP Engineering & Cell Manufacturing Facility, set to be the inaugural of two premier cell and gene therapy hubs in the state of New York. As a pivotal initiative, we are spearheading the formation of a consortium comprising cancer centers across the state, aimed at expeditiously recruiting patients for forthcoming clinical trials. Join us in this groundbreaking venture, positioning your organization at the forefront of cutting-edge cell and gene therapy advancements in New York.
Free Webinar Recording
Advancements in Cellular Therapy at Roswell Park
If you missed the live session, no worries – you can catch up online! Dive into this 90-minute, clinically focused educational program designed for hematologists, oncologists, pharmacists, pathologists, and various healthcare professionals such as PAs, NPs, and RNs. Ideal for those involved in diagnosing, treating, or managing patients with cancer, this online resource ensures you stay updated and informed in your field.
Leadership Team
We have the experts, in-house. From cell biology to first-in-human clinical trials, the deep bench of Roswell Park Comprehensive Cancer Center can be consulted throughout your process.
The GEM leadership and operations team includes individuals with significant accomplishments and experience in clinical manufacturing, immune-analysis, process development, QA, and commercialization of innovative therapies.
Yeong “Christopher” Choi, PhD, MBA
Expertise in GMP, Process Sciences & Tech Transfer
With over two decades of expertise in cell and gene manufacturing, coupled with extensive experience in the biotech sector, Dr. Choi stands out as an industry leader. Recognizing the advantages of in-house development and testing of cellular therapies at Roswell Park, Dr. Choi is committed to expediting the delivery of groundbreaking treatments to patients. Partner with us to leverage this wealth of experience and accelerate advancements in cell and gene therapies through strategic collaboration.
Peter Maslak, MD
Expertise in Immune Therapy, Analytical Development, QC &QA
Boasting over 25 years of expertise in advancing cell-based treatments for leukemia, Dr. Maslak is a distinguished leader in the field. His seasoned leadership in clinical flow cytometry, immunophenotyping, and immune monitoring has solidified his position as a prominent figure in the realm of cell-based therapies. Instrumental in developing laboratory correlates supporting numerous clinical trials, Dr. Maslak brings a wealth of experience to the forefront of cutting-edge advancements. Collaborate with him to drive innovation and excellence in cell-based therapies.
Robert Keem
Over 30 years’ experience in GMP manufacturing
As Director of Cell Therapy Manufacturing, Rob Keem brings over 30 years’ experience in GMP manufacturing, with expertise in manufacturing, quality, and product development. His experience includes starting aseptic operations and building large, high performing teams to support sterile products and getting approval of new drug products.
James Bridges
Certified Quality Auditor, Biomedical Auditor, Certified Six Sigma Green Belt
Roswell Park GMP’s Director of Cell Therapy Quality has 25 years of demonstrated success in pharmaceutical and biological product manufacturing. James has served in roles in QA & QC management, and as an FDA Investigator. He understands quality systems and their impact on creating safe and efficacious cellular products.