Tuesday, April 16, 2024

ThermoGenesis Launches New Facility for Cell and Gene Therapy Development

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A new state-of-the-art facility, designed to function as an incubator, has been opened. The facility boasts of ISO 7 cGMP cleanroom suites and research and development (R&D) labs. The ReadyStart cGMP Cleanrooms and IncuStart Wet Labs that the facility houses offer an ideal environment, equipment, and services for the R&D and cGMP manufacturing of cell and gene therapies, as well as other life science products.

There are 12 leasable cGMP-compliant ISO 7 suites featured in the ReadyStart Cleanrooms. Each of these private cGMP suites is fully equipped and configured to meet the specific requirements of clients. The IncuStart Wet Labs are located within the cGMP facility.

Maintenance and support of the facility will be managed by ThermoGenesis’ operations, quality, regulatory, and scientific personnel. This development aligns with the company’s strategy of transitioning from a medical device company to a provider of cell and gene therapy services and a contract development and manufacturing organisation.

Chris Xu, ThermoGenesis chairman and CEO, expressed that their all-encompassing facility will provide a flexible option, enabling companies to achieve their anticipated milestones faster and more efficiently. Xu further added that their team’s strong expertise in regulatory affairs and product commercialization can help accelerate the development of their customers’ products, and allow them to focus on their science.

ThermoGenesis will manage the regulatory and quality compliances associated with running a cGMP facility. Therefore, companies can focus on their core scientific pursuits while ThermoGenesis handles the regulatory and quality compliances. This new facility is expected to expedite the development of cell and gene therapies and other life science products.

The launch of this new facility marks a significant step in ThermoGenesis’ transition from being a medical device company to a cell and gene therapy services provider and a contract development and manufacturing organisation. It is anticipated to contribute to the progress of the life sciences sector by providing a conducive environment for research, development, and manufacturing.

ThermoGenesis’ new facility, by offering a supportive and compliant environment for the development of cell and gene therapies and other life science products, aims to enable companies to focus on their core scientific work and achieve their milestones more efficiently. The facility’s maintenance and support will be managed by ThermoGenesis’ personnel, providing a reliable and quality-assured space for life science research and development.

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