Catalent, Inc. (NYSE: CTLT), the leading global provider of
advanced delivery technologies, development, and manufacturing
solutions for drugs, biologics, cell and gene therapies, and
consumer health products, today announced that Catalent Cell &
Gene Therapy will provide drug substance manufacturing to
AstraZeneca for the University of Oxford’s adenovirus vector-based
COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy
manufacturing facility located in Harmans, Maryland.
Catalent will prepare the Harmans facility, close to
Baltimore-Washington International (BWI) airport, to enable
multiple production trains to run in parallel to produce the
vaccine candidate drug substance commencing late in the third
quarter of 2020. This agreement expands Catalent’s support of the
AZD1222 program following the announcement in June that Catalent’s
facility in Anagni, Italy, will provide large-scale vial filling
and packaging of AZD1222.
The adenovirus vector-based vaccine candidate, AZD1222, was
co-invented by the University of Oxford and its spin-out company,
Vaccitech, and licensed by AstraZeneca. The vaccine candidate is
currently in clinical trials.
"Catalent has significant experience in viral vector
manufacturing," commented Manja Boerman, Ph.D., President, Catalent
Cell & Gene Therapy. She added, “We are pleased to have the
capabilities at our flagship Catalent Gene Therapy site to expand
our support for the AstraZeneca program, while continuing to serve
our current gene therapy customers. Our gene therapy team is proud
to join our Catalent Biologics colleagues at the Anagni site in the
advancement of AstraZeneca’s COVID-19 vaccine candidate.”
Catalent’s state-of-the-art Harmans/BWI commercial manufacturing
facility is equipped with single-use technology, and houses over
200,000 square feet (18,600 square meters) of late-stage clinical
and commercial-stage gene therapy production. The facility is one
of Catalent’s five gene therapy facilities in Maryland providing
clinical through commercial scale services, and houses multiple
CGMP manufacturing suites, including fill/finish, central services
and testing laboratories, warehousing, and supply chain
capabilities. The Catalent Biologics network also includes sterile
drug product manufacturing and packaging facilities in Anagni,
Italy, Brussels, Belgium, and Bloomington, Indiana, with additional
facilities in Europe and the United States for manufacturing
proteins, cell therapies, and biologics analytical services.
Notes for Editors
About Catalent Cell & Gene Therapy
Catalent Cell & Gene Therapy is a full-service partner for
adeno-associated virus (AAV) vectors and CAR-T immunotherapies,
with deep experience in viral vector scale-up and production.
Catalent recently acquired MaSTherCell, adding expertise in
autologous and allogeneic cell therapy development and
manufacturing to position Catalent as a premier technology,
development and manufacturing partner for innovators across the
entire field of advanced biotherapeutics. Catalent has a global
network of clinical and commercial manufacturing facilities, and
fill-finish and packaging capabilities located in both the U.S. and
Europe. Catalent Cell & Gene Therapy has produced more than 100
cGMP batches across 70+ clinical and commercial programs. For more
information, visit biologics.catalent.com/cell-gene-therapy/
About Catalent
Catalent, Inc. (NYSE: CTLT) is the leading global provider of
advanced delivery technologies, development, and manufacturing
solutions for drugs, biologics, cell and gene therapies, and
consumer health products. With over 85 years serving the industry,
Catalent has proven expertise in bringing more customer products to
market faster, enhancing product performance and ensuring reliable
global clinical and commercial product supply. Catalent employs
over 13,500 people, including over 2,400 scientists and
technicians, at more than 40 facilities, and in fiscal year 2019
generated over $2.5 billion in annual revenue. Catalent is
headquartered in Somerset, New Jersey. For more information, visit
www.catalent.com
More products. Better treatments. Reliably supplied.™
Forward-Looking Statement
Statements concerning the development, success, and
administration of clinical trials, ability to launch, and future
manufacturing contained in this release are forward-looking
statements. They involve known and unknown risks, uncertainties,
and other factors that may cause actual results or performance to
be different from those expressed or implied in this release.
Catalent has based its forward-looking statements on its current
expectations, assumptions, estimates and projections, which it
believes to be reasonable, but various factors, including factors
beyond Catalent’s control, may affect future results or
performance. Among the factors that may affect these
forward-looking statements are: the rapidly changing market for
treatments and vaccines to address the COVID-19 pandemic, the
current or future effects of the COVID-19 pandemic, including its
effects on Catalent’s and its clients' businesses, the outcome of
the development of this or any competing vaccine or any treatment
for COVID-19, the outcome of any and all reviews, inspections or
other approvals by the U.S. Food and Drug Administration (FDA) or
similar regulatory health authority, customer, and payor acceptance
of the proposed vaccine, any competing vaccine, or any treatment
for COVID-19, competitor responses to a potential future launch of
this vaccine, changes to the overall economic climate in the
regions where this product may be marketed or among potential
purchasers of the product, changes to the healthcare reimbursement
system in the regions where this product may be marketed or
elsewhere, competing initiatives at Catalent or AstraZeneca, supply
chain risks relating to the vaccine, fluctuations in currency
exchange rates that affect Catalent’s ability to source the
materials needed for the production of the product, or potential
third-party claims or litigation related to the vaccine. These and
other important factors, including those discussed under “Risk
Factors” in the Catalent, Inc. Annual Report on Form 10-K for the
year ended June 30, 2019 or its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2020, may affect future results or
performance. Catalent makes the statements in this release only as
of the date of this release, and Catalent disclaims any duty,
except as required by law, to update or revise any forward-looking
statement, regardless of the circumstances.
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version on businesswire.com: https://www.businesswire.com/news/home/20200824005052/en/
Media Contacts:
Chris Halling +44 (0)7580 041073 chris.halling@catalent.com
Richard Kerns +44 (0) 161 728 5880 richard@nepr.agency
Investors: Paul Surdez +1 (732) 537-6325
investors@catalent.com
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