Why Choose Roswell Park GMP?
Why Choose Roswell Park GMP?
Achieving a medical breakthrough demands both imagination and unwavering quality. To bring your novel therapy to patients, you require profound knowledge, established processes, and a partner driven by a passion for innovation.
Enter the Roswell Park GMP Engineering & Cell Manufacturing Facility, where scientific rigor, technical expertise, and business acumen converge into a streamlined research and development platform. Our consolidated facilities and services ensure faster delivery at a competitive price, connecting you with our onsite network of globally recognized physicians and scientists.
How do we substantiate our success? With a legacy dating back to 1898, we've been at the forefront of the fight against cancer, maintaining a singular focus and a proven track record. Therapies created and tested here have set standards of treatment worldwide.
At Roswell Park, science meets strategy. Together, we craft bench-to-bedside success stories.
Pre-Clinical & Clinical Trials
End-to-end bench science, clinical research services, medical affairs, regulatory and legal compliance, patient/provider relations, and more.
Manufacturing Process Design & Development
Integrated roadmaps for accelerated planning, scheduling, production, distribution, analytics, reporting, and more.
GMP Production & Site Technical Training
Standard operating procedures, hands-on instrumentation instruction, safety and PPE requirements, change control, and more.
R&D Quality Assurance
Comprehensive strategies for high-quality products that ensure patient safety, lab and data security, environmental monitoring, COC/COI, packaging and labeling, and more. Collaborate with us to navigate every aspect of your therapy development journey, ensuring success from research to commercialization.
Bringing Discoveries Forward, Faster
At Roswell Park's state-of-the-art GMP facility, we transcend being merely a cell therapy process development and manufacturing unit. We stand as an all-encompassing solution for every step of the cell therapy journey. Engage with us to experience a comprehensive approach that ensures success from conception to commercialization in the realm of cell therapy.
End-to-End Support
Our distinctive advantage lies in our capability to accompany a partner throughout the entire spectrum, from the initial stages of pre-clinical research to the critical First in Human (FIH) clinical trials. With an in-house team of experts, we provide unwavering support at every step, ensuring a journey marked by consistency and excellence. Engage with us to experience this comprehensive and supportive approach in advancing your therapeutic innovations.
Seamless Process Development
Our integrated approach ensures a streamlined process development phase. With the ability to swiftly adapt and refine techniques in real time, we significantly reduce the transition period from research to production. Engage with us to benefit from an efficient and dynamic process that expedites the translation of research into production.
Robust IND Development
Leveraging a deep understanding of regulatory requirements derived from extensive cell therapy experience, the Roswell Park GMP facility stands ready to assist in the development of Investigational New Drug (IND) applications. Our expertise aims to significantly reduce the timeline from the laboratory to the clinic. Partner with us to expedite the regulatory processes and bring your innovations to clinical application swiftly and efficiently.
Comprehensive Clinical Trial Management
When you're prepared to transition to the clinical phase, our in-house capabilities encompass the comprehensive management of an entire First in Human (FIH) clinical trial. Collaborate with us to ensure a seamless and expertly handled clinical trial phase for your innovative therapies.
Integrated Vector Production
Our facility is equipped with cutting-edge vector production capabilities, eliminating the need to outsource this crucial component of cell therapy. This guarantees quality, cost reduction, and accelerated timelines. Engage with us to benefit from our in-house vector production expertise that ensures efficiency and excellence in cell therapy development.
State-of-the-Art QC Testing
Our in-house quality control guarantees that each product adheres to the required stringent standards, eliminating the delays associated with external testing. Partner with us to experience a streamlined process that ensures the timely and uncompromising quality of your products.
Efficiency & Cost Control
Our integrated operations enable us to provide comprehensive services at competitive pricing. Furthermore, having all capabilities under one roof ensures tightly controlled turnaround times, optimizing efficiency. Engage with us to benefit from a cost-effective and efficient approach to your project needs.
“What makes Roswell Park different, and what brought me here, is the close communication and partnership between doctors and researchers and the opportunity to work closely with scientific resources and core facilities that are instrumental in developing, refining and advancing new cancer treatments like immune monitoring.”
Peter Maslak, MDDirector, Flow & Immune Analysis Shared Resource