STUTTGART, Germany and BERGISCH
GLADBACH, Germany, July 29, 2021 /PRNewswire/ -- Exyte has
successfully completed the construction of the first
ExyCell® facility in China, the CliniMACS Cell
Factory® of Miltenyi Biotec, a global
provider of integrated solutions for Advanced Therapy Medical
Products (ATMPs). The patented ExyCell technology was developed by
Exyte as an end-to-end, integrated facility solution with
standardized and modularized elements. These pre-configured and
pre-fabricated modules enable fast-track construction thereby
shortening time-to-market for new therapeutics and vaccines. The
ExyCell facility is installed on the fourth
floor of the ATLATL building located in the
Zhangjiang High-Tech Park, and Miltenyi Biotec is now
transferring production technology from Germany to China with regular operations for ATMP
production is expected by autumn 2021. The facility will soon be
open to visitors by appointment.
Through their cooperation, Exyte and Miltenyi Biotec have
developed an innovative, sustainable, and cost-effective facility
for cell therapy manufacturing. This facility combines the
CliniMACS Cell Factory manufacturing platform with the
pre-fabricated ExyCell module enabling a fast deployment of small,
medium, and large scale cell manufacturing facilities based on a
flexible cell therapy manufacturing module. Endusers can purchase a
personalized version of this pre-engineered and pre-fabricated
manufacturing module ready to host their CliniMACSCell Factory for
ATMPs.
Chris Miller, President Global
Business Unit Biopharma and Life Sciences at Exyte stated: "The
completion of the first ExyCell facility with our partner Miltenyi
Biotec marks an important milestone. We consider ExyCell to be a
transformational development of our "next generation" of award
winning modular concepts." Exyte has developed and implemented
several other modular facilities including the renowned Catapult
Development and Manufacturing Centre for cell and gene therapy in
Stevenage, UK, several modular
biotech facilities in China, and a
large modular biomanufacturing facility for upstream and downstream
processing in Lithuania. All these
plants have been designed and constructed, shipped, and installed
for operational readiness.
Dr. Boris Stoffel, Member of the
Management Board of Miltenyi Biotec, emphasized the importance of
this partnership: "As a company, we want to enable our customers in
their efforts to make innovative cell and gene therapies available
to patients worldwide. We believe that combining the proven
CliniMACS Cell Factory manufacturing platform with the
pre-fabricated ExyCell module will help fast-tracking new therapies
to the benefit of global healthcare."
The effective combination of the CliniMACS Cell Factory ballroom
concept built into the ExyCell module allows the flexibility to
build, scale-up, expand, or repurpose a facility with minimal
impact to ongoing production operations. The ExyCell platform can
either be purchased in its standard version or adapted to specific
needs of production capacity, cleanroom size, control systems, and
finishing options. Exyte can build and qualify a turn-key ExyCell
facility in a matter of months. The ExyCell facility sizes
start from 75 m2 for a
fully equipped and operational turnkey facility hosting a CliniMACS
Cell Factory with one to twelve CliniMACS Prodigy®
units, scaling up to several thousand square meters to accomodate
several hundred units. The ExyCell facility can be either
realized in an existing building or built in a greenfield setting
and presents clients with the opportunity for a significant
reduction in construction timelines and overall energy use. The
design is adaptable to any process layout and meets the
requirements for current Good Manufacturing Practice (cGMP).
Innovations in process technology, adaptable plant design,
combined with the integration of physical and virtual supply chains
allow biopharmaceutical manufacturers to remain competitive in a
dynamic market. Biopharmaceutical manufacturers will benefit from
the end-to-end sustainable solutions, which can be deployed
globally, are cost predictable, provide speed to market, and
flexibility for facility re-purposing. This reflects the
characteristics of a drug lifecycle, mitigates associated risks,
and effectively protects the CAPEX (capital expenditure) and OPEX
(operational expenditure).
About Exyte
Exyte is a global leader in the design,
engineering and delivery of facilities for high-tech industries.
With a history of more than 100 years, the company has developed a
unique expertise in controlled and regulated environments. Exyte
has a truly global footprint, serving the most technically
demanding clients in markets such as semiconductors, batteries,
pharmaceuticals, biotechnology, and data centers. The company
offers a full range of services from consulting to the managing of
turnkey solutions – delivered to the highest quality and safety
standards. Solving the most complex challenges, Exyte forges
trusted, long-lasting relationships with its clients. In 2020,
Exyte generated sales of EUR 4.1
billion with around 4,900 highly experienced and motivated
employees. The company is ideally positioned to further strengthen
its market leadership with its broad industry insight and its
exceptional talents.
Contact
Adriana
Williams
Vice President Corporate Communications
& Investor Relations
+49 711 8804 1489
adriana.williams@exyte.net
www.exyte.net
About Miltenyi Biotec
Miltenyi Biotec is a global provider of products and services that
empower biomedical discovery and advance cellular therapy. Our
innovative tools support research at every level, from basic
research to translational research to clinical application. Used by
scientists and clinicians around the world, our technologies enable
solutions for cellular research, cell therapy, and cell
manufacturing. Our more than 30 years of expertise spans research
areas including immunology, stem cell biology, neuroscience, and
cancer. Today, Miltenyi Biotec has more than 3,500 employees in 28
countries – all dedicated to helping researchers and clinicians
make a greater impact on science and health.
Contact
Holger Bülow
Corporate Communications
+49 2204 8306-6680
holgerb@miltenyi.com
www.miltenyibiotec.com
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