Catalent Signs Agreement with Johnson & Johnson to be U.S. Manufacturing Partner for Lead COVID-19 Vaccine Candidate
29 April 2020 - 10:00PM
Business Wire
- Collaboration includes joint investment and tech transfer to
prepare for rapid scale-up and segregated cGMP commercial
manufacturing capacity
- Catalent to hire 300 additional personnel to meet operational
readiness and 24x7 manufacturing schedules
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 a collaboration with the
Janssen Pharmaceutical Companies of Johnson & Johnson, whereby
Catalent’s Biologics business unit will accelerate availability of
manufacturing capacity and prepare for large-scale commercial
manufacturing at its facility in Bloomington, Indiana of Johnson
& Johnson’s lead vaccine candidate for COVID-19.
The collaboration commits joint investment to accelerate rapid
scale-up of segregated manufacturing capacity over the coming
months to support dedicated production of Johnson & Johnson’s
investigational vaccine candidate. Catalent plans to hire
approximately 300 additional employees at the site for this program
starting in July 2020 to meet operational readiness and 24x7
manufacturing schedules by January 2021.
“Catalent is proud to collaborate with Johnson & Johnson in
its efforts to combat the coronavirus pandemic and save lives,”
said John Chiminski, Chair and Chief Executive Officer of Catalent.
“Both organizations have committed to ambitious goals and are
executing innovative strategies to meet the forecasted demand on an
unprecedented timeline. We value the trust that Johnson &
Johnson has placed in us regarding this important, time-sensitive
program and will apply our extensive experience in quickly scaling
up manufacturing operations for late-stage and commercial
products.”
Catalent’s state-of-the-art 875,000 square-foot facility in
Bloomington has deep expertise in sterile formulation, with drug
substance development and manufacturing and drug product
fill/finish capacity across liquid and lyophilized vials, prefilled
syringes, and cartridges as well as primary and secondary
packaging. Scale-up in production will include the use of two new
high-speed machines, including an Optima vial filling line and a
Dividella NeoTOP® 1604 top-load cartoner. In addition to the
Bloomington facility, the Catalent Biologics network has facilities
in Brussels, Belgium and Anagni, Italy that perform sterile drug
product manufacturing and packaging, and additional facilities in
the United States and Europe for manufacturing proteins, viral
vectors for gene therapies, and cell therapies, as well as
pre-filled syringe manufacture and bioanalytics.
For more information about Catalent’s Bloomington facility,
visit
https://biologics.catalent.com/our-locations/north-america/bloomington-usa/.
About Catalent Biologics
Catalent Biologics is a global leader in development,
manufacturing and analytical services for new biological entities,
cell and gene therapies, biosimilars, sterile injectables, and
antibody-drug conjugates. With over 20 years of proven expertise,
Catalent Biologics has worked with 600+ mAbs and 80+ proteins,
produced 13 biopharmaceutical drugs using GPEx® cell line
development technology, and 35+ commercially approved products.
Catalent has recently acquired MaSTherCell, a technology-focused
cell therapy development and manufacturing partner with expertise
in autologous and allogeneic cell therapy that complements
Catalent’s industry-leading expertise and commercial success in
gene therapy development, manufacturing and adeno-associated virus
(AAV) vector production. Together, Paragon Gene Therapy and
MaSTherCell have produced over 100 GMP batches across 60+ clinical
and commercial programs. For more information on Catalent
Biologics, visit www.catalent.com/biologics.
About Catalent
Catalent 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 Notice
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 United
States or among potential purchasers of the product, changes to the
healthcare reimbursement system in the United States or elsewhere,
competing initiatives at Catalent or Janssen, 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, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200429005148/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
Catalent (NYSE:CTLT)
Historical Stock Chart
From Apr 2024 to May 2024
Catalent (NYSE:CTLT)
Historical Stock Chart
From May 2023 to May 2024