GMP Quality Assurance
Good Manufacturing Practices Are Just the Baseline
In the realm of novel therapy development for the business-to-business sector, the significance of experience cannot be overstated. Securing the safety and quality of your innovative therapeutic solutions demands the guidance of seasoned professionals. Our team is dedicated to assisting you in risk mitigation, streamlining processes, eliminating redundancies, fostering transparency, and safeguarding your financial investment.
The key ingredients include scientific rigor, ongoing monitoring, and a steadfast commitment to integrity. Entrust Roswell Park as your Contract Development and Manufacturing Organization partner for a collaborative journey toward success in the landscape.
What Can We Do for You?
We test in-house with processes and standards developed and implemented by widely recognized experts. This means, first, that each product, each batch adheres to the required stringent standards, and, second, that no time is lost by sending samples for external testing. Partner with us to experience a streamlined process that ensures the timely and uncompromising quality of your products.
- Robust QMS
- Facility and equipment controls
- Product and process controls
- Chain of custody and chain of identity traceability
- Continuous monitoring and regular audits
- Investigator and support team training
- Clinical trial validations and qualifications
- Standard operating procedures
- Method qualification, validation, and transfer
- Continuous monitoring
- Manage samples, EM
- In-process final and stability
- Standards and reagents
Beyond the bricks and mortar, our strength lies in our people. We bring to the table deep scientific and technical know-how, readily available to support our partners in realizing their cell therapy ambitions.