Catalent is one of the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. The Catalent Applied Drug Delivery Institute is helping to promote innovation, knowledge-sharing and collaboration between industry leaders, academic experts, customers and regulators—thereby enhancing understanding of available, emerging and future drug delivery technologies, and improving patient care.
Recently the company announced, that they are ready to donate $130 million to add five additional Phase 3 through commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland to support a growing customer pipeline and market demand.
As expected, this funds will add to the Harmans five late-stage clinical and commercial manufacturing suites. Officially they expect to start work in the first half of 2022. These five new suites will be located in the second building, and besides those objects will consist house cold-storage warehousing and added office space. Harmans complex, located in Maryland, is one of five sites where Catalent’s cell and gene therapy manufacturing portfolio.
Catalent 350,000-Square-Foot Complex
The total number of suites after these expansions of built-up areas, gain up to 15, with total area about 350,000-square-foot. The location of the new complex will be near the Baltimore/Washington International airport. Need to be said that FDA recently approved Harmans facility, and its first 10 manufacturing suites, that will be set to be fully operational by the first quarter of 2021.
To date Catalent’s Harmans/BWI commercial manufacturing campus includes over 200,000 square feet of late-stage clinical and commercial-stage gene therapy production.
Support of AstraZeneca New COVID-19 Vaccine
Also, Catalent tasked with finishing and packaging duties for AstraZeneca. Company will help AstaZeneca to produce vaccine from August 2020 till Match 2022, given that vaccine receives full regulatory approval.
“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.”
Besides fill-finish and packaging duties Catalena’s work now will include production of viral vectors for a genetically modified form of 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.
“It is critical that we stay connected to the needs of our customers as they progress through the clinical pipeline. By increasing our late-stage manufacturing capacity at the Harmans campus, we will be able to meet demand through the medium term and take advantage of our shared resources, including the technical and manufacturing expertise that helped us reach the milestone of becoming an FDA-approved commercial partner,” commented Manja Boerman, Ph.D., President, Cell & Gene Therapy at Catalent. “Catalent is committed to this journey with our customers as they bring life-changing therapies to their patients.”