CAR T-Cell R&D
The Next Generation of Immunotherapy
In the landscape of chimeric antigen receptor (CAR) T-cell therapies, notable advancements are transforming survival rates for patients with blood cancers. Capitalizing on these successes, the Roswell Park GMP Engineering & Cell Manufacturing Facility is actively contributing to impactful preclinical research, leveraging CAR T-cell treatments against not only liquid but solid tumors.
Researchers in immunotherapy, spanning the globe, will harness the cutting-edge technology and facilities at Roswell Park Comprehensive Cancer Center to target cancers such as those in the breast, lung, prostate, and beyond. Our institution is home to world-class scientists, clinicians, and technicians, each boasting decades of expertise and experience in the realm of cellular medicine.
To further drive innovation, Roswell Park is significantly expanding both development and production capacities. If you're exploring the potential of CAR T-cell therapies, there's no better destination, and no more adept partner to translate your ideas into impactful clinical trials. Elevate your collaborations by joining forces with us at the forefront of CAR T-cell therapy development and production.
Bringing promising new ideas from the lab to the patient’s bedside where they can save more lives is our ultimate goal — we are here to collaborate with other investigators and companies who share that same passion.
Marco Davila, MD, PhD Senior Vice President and Associate Director for Translational Research
What Can We Do for You?
Whether you are extending the reach of autologous CAR T-cell therapies or exploring the frontiers of allogeneic therapies, the Roswell Park GMP Engineering & Cell Manufacturing Facility gives you the precision, speed, and experience to move your product forward.
Cell Line Development:
- Generation of stable cell lines
- Optimization of cell line performance
- Characterization and banking of cell lines
Process Development:
- Optimization of cell culture conditions
- Scale-up and scale-down models
- Process characterization
- Media optimization
Analytical Development:
- Analytical method development and qualification
- In-process testing
- Release testing for final product
- Stability testing
Clinical Trial Material Manufacturing:
- GMP production of clinical trial material
- Fill and finish operations
- Aseptic processing and packaging
Regulatory Compliance and Documentation:
- Preparation of regulatory submission documents
- Compliance with FDA guidelines
- Quality control and quality assurance systems
- Batch record creation and maintenance
Quality Control Testing:
- Sterility, endotoxin, and mycoplasma testing
- Potency and identity assays
- Purity and impurity testing
Product Release:
- Final product release
- Certificate of analysis generation
- Compliance with product specifications
Supply Chain and Logistics:
- Cold chain logistics
- Material sourcing and management
- Distribution planning and execution
Manufacturing Facility and Equipment:
- State-of-the-art GMP-compliant facilities
- Single-use technology
- Controlled environment rooms and cleanrooms
Cell Therapy Specific Capabilities:
- Autologous and allogeneic cell therapy production
- CAR-T cell therapy development
- Stem cell processing and manufacturing
- Gene editing technologies (e.g., CRISPR)
Project Management:
- Cross-functional project teams
- Timeline and budget management
- Communication with sponsors and stakeholders
Discovery and Early Research:
- Target identification and validation
- Cell-based assay development
- Proof-of-concept studies
- Biomarker discovery and validation
Pre-Clinical Development:
- In vitro and in vivo efficacy models
- Safety and toxicity studies
- Dose-range-finding studies
- Pharmacokinetics and pharmacodynamics (PK/PD) modeling
IND-Enabling Studies:
- Toxicology studies
- Pharmacology and toxicology study design
- Safety assessment and risk analysis
- Regulatory strategy for IND submission
Cell Therapy Product Development:
- Early-stage process development for cell therapies
- Prototype development for novel cell therapies
- Feasibility studies for manufacturing processes
Analytical Method Development:
- Early-stage method development and qualification
- Characterization of raw materials and intermediates
- Development of potency, purity, and identity assays
Clinical trials
- Clinical logistics
- Patient safety
- Process analytics
- Treatment site lifecycle
Quality Assurance
- Active QMS
- Laboratory & test control
- Design, development & lifecycle controls
- Qualification & validation
- Product traceability (COC/COI)
- Facility & equipment controls
- Production & process controls
- Product distribution
Look inside
Embark on CAR T-cell research and development with Roswell Park, where adherence to current Good Manufacturing Practices (cGMP) is paramount. Our commitment is bolstered by industry-leading Quality Control (QC) and Quality Assurance (QA) standards and procedures. This meticulous approach guarantees that your therapy aligns with the standards for Phase I and II clinical trials, meeting the stringent requirements established by the Food and Drug Administration (FDA). Furthermore, it positions your advancement on a trajectory toward a commercially viable product. Partner with us for collaborations that prioritize compliance, quality, and progress in CAR T-cell therapy development.
A legacy of Success
Roswell Park has been at the forefront of CAR T-cell therapy since the beginning, and our experts have some significant breakthroughs on their own CVs. We’ll say it again: Experience matters.
View the list of our active cellular therapy clinical trials.
An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
A Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2 Targeted Chimeric Antigen Receptor T-cells in Subjects with Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or…
Phase I, open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART123 (allogeneic engineered T-cells expressing anti-CD123 chimeric antigen receptor), administered in patients with…
(FT576-101) A Phase I Study of FT576 as Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma
The expanded Roswell Park GMP Engineering & Cell Manufacturing Facility will be the first of two cell and gene therapy hubs in the state of New York. As part of this effort, we’re leading the establishment of a consortium of cancer centers across New York state to rapidly recruit patients for future clinical trials.