Catalent Investing $214 Million to Expand Biologics Capabilities; Invests in Oral Delivery Capabilities

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Andrew Sandford
Vice President, Drug Substance & Biologics Analytical Services
Catalent Pharma Solutions

Catalent has announced multi-site investments to support its biologics and solid oral drug-delivery businesses. Andrew Sandford, Vice President, Drug Substance & Biologics, Analytical Services, Catalent Pharma Solutions, highlighted the expansions at the DCAT Week ’19 Member Company Announcement Forum, which was held March 18, 2019 in New York.

In biologics, Catalent is investing a total of $214 million at its facilities in Madison, Wisconsin and Bloomington, Indiana to add 8,000-liters of biomanufacturing capacity, a 79,000-square foot drug- product manufacturing expansion, and a 15,000-square foot packaging expansion. Specifically, the company is increasing mammalian cell-culture capacity at the company’s Madison site with the build-out of two new suites with completion expected in 2021, which will more than double Catalent’s commercial biomanufacturing capacity. Fill/finish capacity at the Bloomington site will be expanded by 79,000 square feet with the expansion targeted for completion in 2022. The company is also investing $14 million to expand packaging capabilities at its Bloomington site to add automated and partially automated capabilities with the expansion expected to be completed in 2019.

Madison is the site of Catalent’s proprietary GPEx cell-line development technology as well as process development, process characterization, formulation development, and biomanufacturing. The Bloomington site provides biologic-based drug-substance services from process development through biomanufacturing and drug-product services spanning process development, formulation development, fill–finish and packaging. Catalent gained the Bloomington site with its $950-million acquisition of Cook Pharmica in 2017. With the addition of Bloomington, Catalent provides end-to-end biologics development and manufacturing services. Other sites in the network include Brussels, Belgium (pre-filled syringe capabilities), Kansas City, Missouri and Morrisville, North Carolina (stand-alone analytical services), and Emeryville, California (bioconjugation technology).

For solid oral drug delivery, Catalent is investing in new technologies and capacities to broaden its capabilities in patient-centric dose forms and to provide scale-up from early-to-late stage development. The company recently invested in a Gerteis Macro-Pactor commercial-scale roller compactor to allow for granule, pellet, and tablet production and in a laser drill for osmotic drug delivery to increase capabilities for controlled-release tableting and encapsulation at its Winchester, Kentucky site. Additionally, Catalent is currently installing a new, automated bottling line and stick-pack filling machine for primary and secondary packaging across clinical and commercial scales.

In March 2019, Catalent announced an investment of more than $27 million to commercialize Zydis Ultra, an advanced technology for oral disintegrating tablets (ODT), which builds on the company’s Zydis ODT technology to enable four times higher drug load and improved taste-masking capabilities. Catalent’s 250,000-square-foot site in Swindon, UK houses the company’s Zydis fast-dissolving tablet development and manufacturing operation, which produces more than one billion ODTs annually and employs more than 600 people.

Catalent has also invested $5 million at its Somerset, New Jersey, site to expand its OptiMelt hot-melt extrusion (HME) capabilities. The investment includes a number of pieces of equipment to enhance development capabilities for preclinical and early-phase development as well as adding downstream processing technologies to support HME formulations.

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