IRVINE, Calif., Sept. 22, 2016 /PRNewswire/ -- Cryoport,
Inc. (NASDAQ: CYRX, CYRXW) ("Company"), the world's leading
cryogenic logistics company dedicated to the life sciences, today
announced the integration of its proprietary logistics technology,
the Cryoportal™, with Database Integrations, Inc.'s Integrated Cell
Therapy Automated Network (iCAN) scheduling platform. The
integration of these two platforms is designed to solve the
challenges of manufacturing, distribution and global supply chain
planning for the clinical development and commercialization of cell
and gene therapy products.
Cell and gene therapy processes start and end with the patient,
requiring extensive and finely-tuned planning. Whether it is
an autologous treatment (where the patient's cells are used to
manufacture doses specific to that patient) or an allogeneic
treatment (where patients receive cells originally collected from
others) the overall logistics process poses specific challenges
associated with the scheduling, storage and transporting of
biologic commodities used in cell and gene therapy programs,
especially the information appertaining thereto.
Steve Littlefield, President of
Database Integrations said, "Seamless integration with Cryoport's
Cryoportal™ management platform is critical to ensuring rapid and
efficient scheduling, manufacture and transport of cell-based
therapies. Cells are procured from the patients and must be
immediately processed. Because many of these patients are
very ill, there may be only one chance to obtain the sample and
manufacture the potential therapy. In addition, cell degradation
begins immediately, and there may be fewer than 48 hours to
transport the cells to the manufacturing facility."
Tamie Joeckel, Senior Vice
President of Client Services for Cryoport, stated, "Accurate
scheduling, processing, logistics and information are crucial to
successful outcomes for patients. In most clinical and
commercial supply chains for biologic commodities, the process is
linear with the major focus on temperature stability, "chain of
condition," and "chain of custody." For cell and gene therapy
programs, many of the standardized processes do not support the
program's requirements. The supply chain for these treatments
is circular or closed – not linear - and strict distribution
timelines must be coordinated with collection, manufacturing and
patient schedules on both ends of the process."
As a pioneer in immune-based therapies for the treatment of
brain and other cancers, ImmunoCellular Therapeutics, Ltd (NYSE
MKT: IMUC) suggested the integration project. Anthony Gringeri, Senior Vice President,
Strategic Resources at ImmunoCellular stated, "As a client of both
Cryoport and Database Integrations, we saw there were efficiencies
to be gained in overall scheduling and coordination with an
integrated solution. Having an end-to-end, system-managed workflow
eliminates the potential for manual data entry errors and provides
better visibility from the clinical and manufacturing sites and
vital information regarding the condition of the therapy at every
stage of logistics."
How The Integrated System Works
iCAN is flexible and can be customized to address specific
protocols. The system tracks patient dosing dates and
frequencies, which are then cross referenced against the
manufacturing capacities. The clinical site selects the
patient and the system sends a dose ordering form and an
authorization to release the patient-specific, serialized
vial. The system simultaneously sends an order to the
Cryoportal™ which alerts Cryoport to ship it via Cryoport
Express® Shipper to the manufacturer. Once
the manufacturing process occurs and the Contract Manufacturing
Organization ("CMO") loads the therapy into Cryoport
Express® Shipper, it is sent to the clinical site.
With patient safety always the top priority, the shipments are
actively monitored continuously by Cryoport's SmartPak II™
condition monitoring system which seamlessly communicates and
records information with the proprietary Cryoportal™ to ensure
temperature stability, package orientation and location are
maintained at all times.
Ms. Joeckel stated, "We are very excited to bring a cohesive,
seamless solution to the immunotherapy market. Cellular and gene
therapies are changing the face of medicine and Cryoport is excited
to be a vital part of the solution. As these clinical trials
approach commercialization with global access, the ability to
manage the holistic supply chain is critical. As Tom
Whitehead, father of Emily
Whitehead, the first child to be treated in a trial of T
cell therapy for acute lymphoblastic leukemia, commented to me
recently at the CAR T-cell Summit in Boston, 'It's not just a shipper, it's a
life.' I don't think there is a better way to summarize the
importance of the solutions we bring to the market."
About Cryoport, Inc.
Cryoport is the life sciences industry's most trusted global
provider of cold chain logistics solutions for
temperature-sensitive life sciences commodities, serving the
biopharmaceutical market with leading-edge logistics solutions for
biologic materials, such as immunotherapies, stem cells and CAR-T
cells. Cryoport's solutions are used by points-of-care, CRO's,
central laboratories, pharmaceutical companies, manufacturers,
university researchers et al; as well as the reproductive medicine
market, primarily in IVF and surrogacy; and the animal health
market, primarily in the areas of vaccines and reproductive
medicine. Cryoport's proprietary Cryoport Express® Shippers,
Cryoportal™ Logistics Management Platform, leading-edge SmartPak
II™ Condition Monitoring System and geo-sensing technology, paired
with unparalleled cold chain logistics expertise and 24/7 client
support, make Cryoport the end-to-end cold chain logistics
partner that the industry trusts.
Cryoport is dedicated to
- simplifying global cold chain logistics through innovative
technology, unmatched monitoring and data capture and support,
including consulting;
- delivering the most advanced temperature controlled logistics
solutions for the life sciences industry; and
- providing vital information that provides peace of mind
throughout the life of each logistics process
For more information, visit www.cryoport.com. To download
Cryoport's investor relations app, which offers access to SEC
documents, press releases, videos, audiocasts and more, please
click to download from your iPhone and iPad or Android mobile
device.
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 annual report on Form 10-K for the year ended
March 31, 2016. 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.