- 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 24×7 manufacturing schedules
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 24×7 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/.
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
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
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.