ThermoGenesis Holdings has opened a new 35,500ft² ReadyStart-IncuStart cGMP facility in Greater Sacramento in Northern California, US.
Designed to serve as an incubator facility, the new modern facility includes ISO 7 cGMP cleanroom suites, as well as research and development (R&D) labs.
The ReadyStart cGMP Cleanrooms and IncuStart Wet Labs offer a cleanroom environment, equipment, and services for R&D and cGMP manufacturing of cell and gene therapies and other life science products.
The ReadyStart Cleanrooms feature 12 leasable cGMP-compliant ISO 7 suites.
Each private cGMP suite is fully equipped and configured to meet the specific requirements of the clients. The IncuStart Wet Labs are located within the cGMP facility.
Furthermore, ThermoGenesis’ operations, quality, regulatory, and scientific personnel will be responsible for the maintenance and support of the facility.
The roll out of the ReadyStart Cleanroom suites aligns with the company’s plan of transitioning from a medical device company to a cell and gene therapy services provider and a contract development and manufacturing organisation.
ThermoGenesis chairman and CEO Chris Xu said: “Our all-encompassing facility will provide a flexible option, enabling companies to achieve their anticipated milestones faster and more efficiently.
“Additionally, our team’s strong expertise in regulatory affairs and product commercialisation can help accelerate the development of our customers’ products, allowing them to focus on their science, while ThermoGenesis will manage the regulatory and quality compliances associated with running a cGMP facility.”