ThermoGenesis Holdings, Inc., a market leader in automated cell processing and cell and gene therapy services, announced the grand opening of its new state-of-the-art facility, housing ISO 7 cGMP cleanroom suites, along with research and development labs. The Grand Opening Celebration for the ReadyStart Cleanrooms and IncuStart Wet Labs was held at the facility located at 2890 Kilgore Rd., Rancho Cordova, CA 95670.
The state-of-the-art ReadyStart cGMP Cleanrooms and IncuStart Wet Labs will be an incubator facility which will provide the cleanroom environment, equipment, and services needed for R&D and cGMP manufacturing of cell and gene therapies and other life science products. The rollout of the ReadyStart Cleanroom suites is part of ThermoGenesis' previously announced plan to transform from a medical device company to a cell and gene therapy services company and, eventually, a contract development and manufacturing organization (CDMO).
The ReadyStart Cleanrooms consist of twelve leasable cGMP compliant ISO 7 cleanroom suites. Each private cGMP suite comes fully equipped and can be configured to meet the client's specific needs. Within the cGMP facility are the IncuStart Wet Labs. The facility will be maintained and supported by ThermoGenesis' operations, quality, regulatory and scientific staff, with more than 25 years of industry experience.
"We launched the innovative, flexible ReadyStart cGMP Suites and IncuStart Wet Labs to better support the research and clinical development of cell and gene therapy products. Early-stage life science and cell and gene therapy companies face a long and complex path to product commercialization, often while being constrained by limited budgets," stated Chris Xu, Ph.D., Chairman and Chief Executive Officer of ThermoGenesis. "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 commercialization 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."
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