IRVINE, Calif., Sept. 18, 2019 /PRNewswire/ -- Cryoport,
Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport"), the world's
leading temperature-controlled logistics solutions company
dedicated to the life sciences industry, today announced the launch
of its Advanced Therapy Shipper™ product line for the regenerative
medicine market. The Advanced Therapy Shipper™ guarantees each
shipper has been used only for human use and provide complete
traceability of all equipment, components and commodities.
The result is unmatched verification information and unmatched
supply chain support for biopharma companies researching and
commercializing cell and gene therapies.
Cryoport's new line of Advanced Therapy Shippers™ have been
launched following strong client demand and in anticipation of more
stringent government regulations. This first of their kind Cryoport
Express™ shipper reduces the potential risk of cross contamination
of materials during use, delivery and distribution of
biopharmaceutical materials supporting advanced cell and gene
therapies.
In addition to a fully segregated shipper fleet, the Cryoport
Express™ Advanced Therapy ShipperTM line is the first in
the industry to employ fully validated cleaning processes which
reduce external contaminants on all equipment by 99.9999%. The
Advanced Therapy Shipper™ line is the latest in Cryoport's Chain
of Compliance™ solutions, providing complete traceability of
historical contents and providing reassurance to clinical and
commercial advanced therapy sites requiring certification that any
and all equipment has been used for clinical trials and commercial
materials only.
Jerrell Shelton, Cryoport CEO,
said, "Having signed 62 new biopharma customers since the beginning
of the year, Cryoport has earned and enjoys a strong leadership
position in the market for temperature-controlled logistics
solutions for the cell & gene industry. Today's introduction of
our new Cryoport Express™ Advanced Therapy Shippers™ further
widens the gap between Cryoport and any would-be competitors. These
revolutionary Cryoport Express™ Shippers extend our market leading
Chain of Compliance™ solution by providing complete
traceability of, not only the respective commodity history of
shipments, but of the historical use, performance, handling,
cleaning and disinfection of all equipment and components as
well. At Cryoport, we endeavor to stay close to the market and
as the cell and gene therapy market matures, we expect regulations
will continue to become more rigorous in recognition of the complex
manufacturing methods for cellular and gene therapies. As always,
our cutting-edge solutions ensure our clients that they are always
one step ahead of these changes to minimize any potential
disruption to their business."
As part of the Company's Chain of Compliance™ solution,
Cryoport's Advanced Therapy Shipper™ fleet will:
- Ensure use only for cell and gene therapies, containing human
clinical trial and commercial materials
- Be segregated from other shipper fleets and processes
- Ensure all shipper components and materials maintain defined
standards to ensure protection from cross-contamination
- Contain a new and validated cleaning and disinfection process
resulting in a 6-log reduction of tested biological indicators
- Provide certification that each shipper is dedicated for
advanced cell and gene therapy use
- Integrate into the Cryoportal® Logistics Management Platform to
prevent violation of procedures and prevent cross
contamination
- Assure that each dewar is requalified after each use for
physical suitability, cleanliness, LN2 capacity, and shipment hold
times.
Cryoport Express™ Advanced Therapy ShippersTM are
validated to ISTA 3A and 7E Transportation Standards and include a
new vapor plug that further de-risks shipments by doubling the
holding time of mis-orientated shippers during transit.
About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX) is
the world's premier provider of temperature-controlled
logistics solutions for the life sciences industry, serving
the Biopharma market. Our mission is to support life and health on
earth by providing reliable and comprehensive solutions for the
life sciences through our advanced technologies, Global Supply
Chain Network and dedicated scientists, technicians and supporting
team of professionals. Through purpose-built proprietary packaging;
information technology; smart, sustainable cold chain logistics;
and biostorage/biobanking services, Cryoport helps its customers
advance life sciences research and deliver vaccines, medicines, IVF
treatments and life-saving advanced therapies in over 100 countries
around the world. For more information, visit www.cryoport.com or
follow @cryoport on Twitter at www.twitter.com/cryoport for
live updates.
Forward Looking Statements
Statements in
this news release which are not purely historical, including
statements regarding Cryoport, Inc.'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. It is important
to note that the Company'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 conditions, trends in the products markets,
variations in the Company's cash flow, market acceptance risks, and
technical development risks. The Company's business could be
affected by a number of other factors, including the risk factors
listed from time to time in the Company's SEC reports including,
but not limited to, the Company's 10-K for the year ended
December 31, 2018 filed with the SEC.
The Company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release.
Cryoport, Inc. 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.