An ISO 7 cGMP Cleanroom Facility Grand Opening On October 26, 2023
RANCHO CORDOVA, Calif., October 26, 2023 — ThermoGenesis Holdings, Inc. (Nasdaq: THMO), 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 today 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.”
Keep life science talents and dollars in the Greater Sacramento Area
The Sacramento region has tremendous economic and human value when compared to other life sciences hubs like San Diego, Boston, and the Bay Area. Greater Sacramento offers significant operating cost advantages for R&D companies, produces a high percentage of bachelor’s degrees in STEM fields, and is a top market for diversity, with over 52% of the population being of a diverse ethnic background.
“ThermoGenesis has made a long-standing investment, having been in Rancho Cordova since 1986. We’re proud to have a pioneer in the automated cell processing and banking industry here, and we applaud them for being at the forefront of scientific innovation,” said Mayor Linda Budge. “This next chapter—ReadyStart CleanRooms and IncuStart Wet Labs—represents the transformation of the traditional office park into a thriving innovation hub, and I have no doubt it will produce the next important breakthrough in the life sciences field.”
Greater Sacramento is experiencing an accelerated growth in its life sciences industry. ThermoGenesis’ multi-million-dollar investment is proof of the Company’s commitment to expanding the life sciences footprint and access in the area. Altogether, recent biotechnology investments in the region will create over 1,000 science-related jobs and hundreds of millions of dollars in economic impact.
“We are thrilled ThermoGenesis is in our market, specifically in Rancho Cordova, building the world-class ReadyStart Cleanrooms and IncuStart Wet Labs for the Sacramento region,” Greater Sacramento Economic Council President & CEO Barry Broome said. “ This incubator facility will allow scientists to develop and commercialize their product providing new cell and gene therapy technologies.”
About ThermoGenesis Holdings, Inc.
Since its inception over 35 years ago, ThermoGenesis Holdings, Inc. has become a leading developer and marketer of a range of commercialized, automated technologies for CAR-T and other cell-based therapies, clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. The Company has recently shifted its focus to the research, development, and manufacturing of immunotherapies and regenerative medicine solutions, with the goal of becoming a high-performance, integrated contract development and manufacturing organization (CDMO), specializing in cell and gene therapy. For more information about ThermoGenesis, please visit: www.thermogenesis.com.
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements contained herein. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect” and similar expressions as they relate to the Company or its management are intended to identify such forward-looking statements. Actual results, performance or achievements could differ materially from the results expressed in or implied by these forward-looking statements. Readers should be aware of important factors that, in some cases, have affected, and in the future could affect, actual results to differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. These factors include without limitation, the ability to obtain capital and other financing in the amounts and at the times needed to launch new products and grow our CDMO business, market acceptance of new products, the nature and timing of regulatory approvals for both new products and existing products for which the Company proposes new claims, realization of forecasted revenues, expenses and income, initiatives by competitors, price pressures, failure to meet FDA regulated requirements governing the Company’s products and operations (including the potential for product recalls associated with such regulations), risks associated with initiating manufacturing for new products, failure to meet Foreign Corrupt Practice Act regulations, legal proceedings, risks associated with expanding into the Company’s planned CDMO business, uncertainty associated with the COVID-19 pandemic, and other risk factors listed from time to time in our reports with the Securities and Exchange Commission (“SEC”), including, in particular, those set forth in ThermoGenesis Holdings’ Form 10-K for the year ended December 31, 2022.
Investor Relations Contact:
Paula Schwartz, RX Communications