All Three MVE Biological Solutions'
Manufacturing Facilities Are Registered With the FDA and All
Applicable MVE Products Are Now Listed
NASHVILLE, Tenn., Jan. 6, 2025
/PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX), a global leader
in supply chain solutions for the life sciences industry, today
announced that MVE Biological Solutions ("MVE"), a Cryoport company
and the leading global manufacturer of high-quality cryogenic
freezers and dewars, has officially registered all three of its
manufacturing facilities (located in Ball
Ground, Georgia; New Prague,
Minnesota; and Chengdu,
China) with the U.S. Food and Drug Administration ("FDA").
Additionally, all applicable MVE-manufactured cryogenic freezers
and dewars are now listed with the FDA.
To meet the standards of FDA-registered facilities, MVE adheres
to stringent requirements, including but not limited to 21 CFR Part
820 and Good Manufacturing Practices ("GMP"). This FDA registration
and product listing is in addition to MVE's existing ISO 13485
certification.
"MVE's achievement underscores our commitment to delivering the
highest-quality and most reliable supply chain solutions for the
life sciences industry," said Jerrell
Shelton, CEO, Cryoport. "Our MVE team's dedication to
serving our clients' needs and bringing lifesaving therapies to
patients is consistent with the high standards we practice in all
business units companywide. This FDA registration reflects MVE's
commitment to excellence by meeting the strictest of global
regulatory standards."
Cryoport clients, customers and/or partners who wish to verify
MVE's registration may do so through the FDA's database or by
contacting the Company at customerservice.usa@mvebio.com.
About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX), is a global leader in supply
chain solutions for cell & gene therapies that enable
manufacturers, contract development manufacturers (CDMOs), contract
research organizations (CROs), developers, and researchers to carry
out their respective business with certainty. We provide a broad
array of supply chain solutions for the life sciences industry.
Through our platform of critical products and solutions, which
include advanced temperature-controlled packaging, informatics,
specialized bio-logistics services, bio-storage, bio-services, and
cryogenic systems, we are "Enabling the Future of Medicine™"
worldwide, through our innovative systems, compliant procedures,
and agile approach to superior supply chain management.
Its corporate headquarters, located in Nashville, Tennessee, is complimented by over
50 global locations in 17 countries, with key sites in the United States, United Kingdom, France, the
Netherlands, Portugal,
Germany, Japan, Australia, India, and China.
For more information, http://www.cryoportinc.com or
follow via LinkedIn
at https://www.linkedin.com/company/cryoportinc or
@cryoport on X, formerly known as Twitter,
at www.twitter.com/cryoport for live updates.
About MVE Biological Solutions®
MVE Biological Solutions® is the global leading manufacturer of
cryogenic storage and shipping devices. For over 60 years, we set
the standard for storing biological materials at low temperatures.
MVE is the preferred brand for cryogenic equipment in various
application areas, including biopharma, cell and gene therapies,
storage of cord blood and stem cells, medical research facilities,
government institutions, IVF centers, hospitals and clinics, and
animal husbandry and livestock.
MVE's headquarters and manufacturing facility is located in
Ball Ground, Georgia, with
additional manufacturing facilities in New Prague, Minnesota, and Chengdu, China. MVE products are distributed
globally in 88 countries.
For more information, http://www.mvebio.com or follow
via LinkedIn
at https://www.linkedin.com/company/mvebio or
@mvebiosolutions on X, formerly known as Twitter,
at www.twitter.com/mvebiosolutions for live
updates.
Forward-Looking Statements
Statements in this press release which are not purely
historical, including statements regarding Cryoport's intentions,
hopes, beliefs, expectations, representations, projections, plans
or predictions of the future, are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements include, but are not limited
to, those related to Cryoport receiving FDA registration for MVE
Biological Solutions' manufacturing facilities, including the
potential impact on future revenue and revenue streams. It is
important to note that Cryoport's actual results could differ
materially from those in any such forward-looking statements.
Factors that could cause actual results to differ materially
include, but are not limited to, risks and uncertainties associated
with the effect of changing economic and geopolitical conditions,
supply chain constraints, inflationary pressures, the effects of
foreign currency fluctuations, trends in the products markets,
variations in Cryoport's cash flow, market acceptance risks, and
technical development risks. Cryoport's business could be affected
by other factors discussed in Cryoport's SEC reports, including in
the "Risk Factors" section of its most recently filed periodic
reports on Form 10-K and Form 10-Q, as well as in its subsequent
filings with the SEC. The forward-looking statements contained in
this press release speak only as of the date hereof and Cryoport
cautions investors not to place undue reliance on these
forward-looking statements. Except as required by law, Cryoport
disclaims any obligation, and does not undertake to update or
revise any forward-looking statements in this press
release.
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SOURCE Cryoport, Inc.