Accelerate your Cell Bank Production
Our global facilities are purposely designed to deliver high-quality, cell-based therapy products from development to clinical and commercial manufacturing.
At RoslinCT, we offer comprehensive cGMP cell banking services using our streamlined platform CORE. Alternatively, we provide tailored solutions to suit specific client processes. With our cutting-edge facilities and expertise, we consistently deliver exceptional quality and comply with international regulatory standards.
Our Offering:
- Master Cell Banks (MCBs) and Working Cell Banks (WCBs): We specialise in the generation and characterisation of cGMP MCBs and WCBs, providing a reliable foundation for your cell-based therapies.
- Dedicated cGMP Facility: Our licenced facility adheres strictly to current Good Manufacturing Practice (cGMP) guidelines, ensuring the integrity and safety of your cell bank.
- The CORE platform: Using our standard 2D format with optimised seed train, expansion and harvest parameters we can generate cell banks up to 250 vials. Our templated documentation speeds up your cell banking project.
- Platform Aseptic Process Simulation (APS): Our platform APS ensures the aseptic integrity of our process, mitigating risks and ensuring product purity and safety. The meticulous platform design means a simple bridging study is likely to be the only add-on component for bespoke processes.
- Cryopreservation and Storage: We offer controlled-rate cell freezing and storage in vapour-phase nitrogen tanks. These are monitored and alarmed 24/7 for ultimate security.
- QC Analysis: Our in-house QC team and network of approved contract testing laboratories, conduct rigorous quality control analysis, ensuring the consistency and purity of your cell banks.
- Quality Assurance: Cell banks are generated within a licenced GMP facility with QA oversight and release certification.
- Bespoke Client-Specific Processes: We understand that each cell therapy process is unique and may sit outside of our platform. Our team is dedicated to accommodating bespoke processes tailored to your specific requirements.
Why Choose RoslinCT for Cell Banking?
Expertise: Our team of experienced professionals brings expertise across a wide range of cell types including iPSCs, hESCs and MSCs.
Compliance: We adhere to the highest regulatory standards, providing assurance of quality and compliance throughout the process.
Reliability: With a focus on quality control and precision, we deliver reliable cell banking solutions you can trust.
Partner with us for your cell banking needs and unlock the potential of your cell-based therapies. Contact us today to learn more about our services and how we can support your project.
The Significance of Cell Banking
As cell therapy advances towards scalable allogeneic treatments, the creation of GMP-compliant cell banks becomes crucial for ensuring long-term supply, consistency, and product quality, underpinning both clinical and commercial success.
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