Reports related to this article:
Project(s): View 3 related projects in PECWeb
Plant(s): View 1 related plant in PECWeb
Released August 16, 2021 | GALWAY, IRELAND
en
Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Catalent (NYSE: CTLT) (Somerset, New Jersey), a leading contract development and manufacturing organization (CDMO), has kicked off a US$100 planned expansion of its Italian facility in Anagni.
The company, which is already filling millions of vials with COVID-19 vaccines for AstraZeneca (Cambridge, U.K.) and Johnson & Johnson (NYSE:JNJ) (New Brunswick, New Jersey) at the site, wants to add biologics drug substance manufacturing capabilities, supporting what it called "the growing European market demand for biologics manufacture and supply."
The initial phase of the expansion will see the installation of two 2,000-liter single-use bioreactors within new, purpose-built manufacturing suites and associated investments to support early-phase clinical development as well as late-stage and commercial tech transfers. It also will add the infrastructure required for a further six 2,000-liter single-use bioreactors. The initial expansion is expected to be commissioned and operational for customer projects by April 2023 and will increase the site's workforce by up to 100 employees. Later phases of the planned expansion contemplate the provision of 16,000 liters of total flexible manufacturing capacity, enabling 2,000-liter to 8,000-liter batch production scale. Industrial Info is tracking all of the key projects. Subscribers to Industrial Info's Global Market Intelligence (GMI) Pharma-Biotech Project Database can click here for the detailed project reports.
The Anagni facility was acquired in January 2020 from Bristol-Myers Squibb. The 28,000 square-meter (305,000 square-feet) facility offers aseptic liquid and powder filling for biologics and sterile products across multiple vial sizes, primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile and biologics products. At the time Catalent committed to expanding the plant.
"In Europe there is a shortage of capacity of bioreactors for biologic (drugs)," Mario Gargiulo, Catalent's region president of Biologics in Europe, told Reuters. "We thought that this was the right place to create this capability, a capability that can be used for a public health emergency like COVID-19." He added: "Catalent was an early adopter of single-use technology because of its flexibility, and we continue to invest in technology that enables adaptable, scalable solutions for the fast-growing segment of biologics addressing mid-sized and orphan patient populations."
In Europe, the company's biologics' network includes a clinical formulation and drug product fill-finish facility in Limoges, France, which is currently being expanded, as well as a site in Brussels, Belgium, the company's flagship European syringe filling facility. It is one of the largest syringe filling capacities in Europe at over 175 million units annually. In the U.S., the company offers mammalian drug substance development and manufacturing for clinical and commercial programs at its Madison, Wisconsin, and Bloomington, Indiana, facilities.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities. Follow IIR on: Facebook - Twitter - LinkedIn.
The company, which is already filling millions of vials with COVID-19 vaccines for AstraZeneca (Cambridge, U.K.) and Johnson & Johnson (NYSE:JNJ) (New Brunswick, New Jersey) at the site, wants to add biologics drug substance manufacturing capabilities, supporting what it called "the growing European market demand for biologics manufacture and supply."
The initial phase of the expansion will see the installation of two 2,000-liter single-use bioreactors within new, purpose-built manufacturing suites and associated investments to support early-phase clinical development as well as late-stage and commercial tech transfers. It also will add the infrastructure required for a further six 2,000-liter single-use bioreactors. The initial expansion is expected to be commissioned and operational for customer projects by April 2023 and will increase the site's workforce by up to 100 employees. Later phases of the planned expansion contemplate the provision of 16,000 liters of total flexible manufacturing capacity, enabling 2,000-liter to 8,000-liter batch production scale. Industrial Info is tracking all of the key projects. Subscribers to Industrial Info's Global Market Intelligence (GMI) Pharma-Biotech Project Database can click here for the detailed project reports.
The Anagni facility was acquired in January 2020 from Bristol-Myers Squibb. The 28,000 square-meter (305,000 square-feet) facility offers aseptic liquid and powder filling for biologics and sterile products across multiple vial sizes, primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile and biologics products. At the time Catalent committed to expanding the plant.
"In Europe there is a shortage of capacity of bioreactors for biologic (drugs)," Mario Gargiulo, Catalent's region president of Biologics in Europe, told Reuters. "We thought that this was the right place to create this capability, a capability that can be used for a public health emergency like COVID-19." He added: "Catalent was an early adopter of single-use technology because of its flexibility, and we continue to invest in technology that enables adaptable, scalable solutions for the fast-growing segment of biologics addressing mid-sized and orphan patient populations."
In Europe, the company's biologics' network includes a clinical formulation and drug product fill-finish facility in Limoges, France, which is currently being expanded, as well as a site in Brussels, Belgium, the company's flagship European syringe filling facility. It is one of the largest syringe filling capacities in Europe at over 175 million units annually. In the U.S., the company offers mammalian drug substance development and manufacturing for clinical and commercial programs at its Madison, Wisconsin, and Bloomington, Indiana, facilities.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities. Follow IIR on: Facebook - Twitter - LinkedIn.
