The Path to Commercialization
End-to-End Innovation
Navigating the dynamic landscape of cellular therapy demands strategic efficiency, and the Roswell Park GMP Engineering & Cell Manufacturing Facility is poised to propel your innovations to clinic rapidly. Our facility is designed to streamline the complex innovation cycle, ensuring timely delivery of your product to the clinic.
Our commitment does not conclude there. Armed with unparalleled industry insights, specialized knowledge, and established processes, we demonstrate the rigorous testing of your life-saving therapeutics through first-in-human clinical trials.
When the time comes to manufacture in support of clinical production, Roswell Park stands as a trusted partner. With over 125 years of successful legacy, we guarantee a robust and mutually beneficial partnership that ensures scalability, speed, consistency, and efficiency.
What Can We Do for You?
Engage with us to harness the collective expertise of Roswell Park and leverage the full spectrum of our biopharmaceutical services for the success of your projects.
- Generation of stable cell lines
- Optimization of cell line performance
- Characterization and banking of cell lines
- Optimization of cell culture conditions
- Scale-up and scale-down models
- Process characterization
- Media optimization
- Analytical method development and qualification
- In-process testing
- Release testing for final product
- Stability testing
- GMP production of clinical trial material
- Fill and finish operations
- Aseptic processing and packaging
- Preparation of regulatory submission documents
- Compliance with FDA guidelines
- Quality control and quality assurance systems
- Batch record creation and maintenance
- Sterility, endotoxin, and mycoplasma testing
- Potency and identity assays
- Purity and impurity testing
- Final product release
- Cold chain logistics
- Material sourcing and management
- Distribution planning and execution
- State-of-the-art GMP-compliant facilities
- Single-use technology
- Controlled environment rooms and cleanrooms
- Autologous and allogeneic cell therapy production
- CAR T-cell therapy development
- Stem cell processing and manufacturing
- Gene editing technologies (e.g., CRISPR)
- Cross-functional project teams
- Timeline and budget management
- Communication with sponsors and stakeholders
Moving a scientific concept from ideation to commercialization requires a carefully coordinated intersection of many disciplines with vast experience and expertise. The depth and breadth of our GMP facility capabilities and the team we have assembled highlights our commitment to being at the forefront of research and medical innovation — and enables the success of our partners in advancing effective cell therapy technologies
Yeong “Christopher” Choi, PhD, MBA Technical Director, GMP Facility