Aileen Ruff Vice President, Business Unit Strategy & Marketing, Biologics & Specialty Drug Delivery Catalent Pharma Solutions

Aileen Ruff, Vice President, Business Unit Strategy and Marketing, Biologics and Specialty Drug Delivery, Catalent Pharma Solutions, updated the progress of Catalent’s integration of its $950-million acquisition of Cook Pharmica, a Bloomington, Indiana contract development and manufacturing organization of biologic drug substances and parenteral drug products, at the DCAT Week ’18 Member Company Announcement Forum, which was held Monday, March 19, 2018 in New York. She also announced expansion of the company’s biologics manufacturing capacity at the company’s facility in Madison, Wisconsin.

Catalent completed the acquisition of Cook Pharmica in late October 2017 and is in progress of integrating the company into its operations. As Ruff outlined, the acquisition strengthened Catalent’s position in biologics development, manufacturing and finished-product supply. With the acquisition of Cook Pharmica, Catalent gains additional expertise in liquid and lyophilized sterile formulation, fill/finish across vials, prefilled syringes, auto-injectors, cartridges and safety devices, and 2,500 liters of biomanufacturing capacity to augment Catalent’s growing biologics business. To maximize the benefits of the Cook Pharmica acquisition and to demonstrate a commitment to continued growth and investment in its biologics business, Catalent has created a new, dedicated business unit focused on Biologics and Specialty Drug Delivery, which spans biologics development, analytical services, and drug-substance and drug-product manufacturing, in addition to Catalent’s respiratory and ophthalmic platforms.

With substantial market growth projected in biologics, Ruff announced that Catalent is also investing to expand its biomanufacturing capacity. On an industry level, she explained that while demand remains for large-scale production, more specialized, smaller-scale capacity is also required to support orphan drugs and other therapies directed at more targeted patient populations. In response to this demand, she noted that Catalent invested and recently concluded installation of additional biomanufacturing capacity in its Madison, Wisconsin facility. This investment adds 2 x 2,000-L single-use bioreactors in Madison. The configuration allows for 2,000-L or 4,000-L batches to position the company for both larger scale clinical and commercial production.

Ruff further noted that to support projected growth in biologics from early cell-line engineering through commercial supply, Catalent has and will continue to invest in its fill/finish capability. Most recently, the newly acquired Bloomington site from Cook Pharmica brought on line a flexible sterile filling line that can support vials, syringes, and cartridges, with ready-to-use components and an option for lyo-capping from Bloomington’s existing vial line to a vial to be capped while also filling other components simultaneously. The line was qualified in the third quarter of 2017 and is available to support customer programs.