An ISO 7 cGMP Cleanroom Facility Grand Opening
On October 26, 2023
RANCHO
CORDOVA, Calif., Oct. 26,
2023 /PRNewswire/ -- 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.
For more information about the new ReadyStart and IncuStart
facility please visit: www.readystartcleanrooms.com
and www.incustartwetlabs.com
Forward-Looking Statements
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.
Contact Information
Company Contact:
Wendy
Samford
916-858-5191
ir@thermogenesis.com
Investor Relations Contact:
Paula Schwartz, RX Communications
917-322-2216
pschwartz@rxir.com
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SOURCE ThermoGenesis Holdings, Inc.