Cellares has unveiled its first current Good Manufacturing Practice (cGMP)-compliant Cell Shuttle platform for cell therapy manufacturing at its Center of Excellence in South San Francisco, US.
The US-based firm is an integrated development and manufacturing organisation (IDMO) focused on clinical and industrial-scale cell therapy manufacturing.
The Cell Shuttle is an automated, ultra-high throughput, manufacturing platform. It is designed to address the global patient demand while lowering process failure rates and costs.
The launch of the new version of the Cell Shuttle platform represents a significant milestone to ensure clinical readiness by the end of 2024, said Cellares.
Patient safety is ensured by cGMP compliance, which verifies that the Cell Shuttle was built and operated as per quality standards that satisfy stringent regulatory criteria.
Cellares said that the cell therapy field faces obstacles like the limited scalability of manual manufacturing processes, elevated expenses, and increased rates of process failure.
Cell Shuttle offers an automated manufacturing solution that is said to minimise personnel and facility size requirements by 90%.
With the same staff and physical space, Cellares’ IDMO Smart Factories will be able to produce 10 times as many cell therapy batches annually as traditional CDMO facilities.
Cellares CEO Fabian Gerlinghaus said: “The completion of our first cGMP-compliant Cell Shuttle instills confidence among healthcare providers, patients, and partners in the quality and reliability of the Cell Shuttle and signals our commitment to the highest standards of production.
“By adhering to cGMP standards, Cellares ensures that cell therapies produced on the Cell Shuttle are safe, effective, and are consistently of the highest quality which is critical for patient care and therapeutic outcomes.”
Last year in August, the company secured $255m in Series C funding to launch its first commercial-scale 118,000ft2 IDMO Smart Factory in Bridgewater, New Jersey. The American IDMO has raised over $355m in overall financing rounds.
