Capsugel added the Tampa, Florida facility in 2015 through the acquisition of Xcelience. The plant is now part of Lonza’s solid oral and inhaled dosage forms network after the Swiss contract development and manufacturing organisation (CDMO) bought Capsugel last June for $5.5bn.
The site houses Xcelodose encapsulation units, but the addition of a Harro Hӧfliger Modu-C MS encapsulation unit (Harro unit) will exponentially increase encapsulation capacity and cater for growing demand in highly potent active pharmaceutical ingredient (HPAPI) services, head of the facility Robert Berland said.
“An Xcelodose 600 unit has nameplate capacity of 600 capsules per hour, or about 15,000 capsules per day. By contrast, the Harro Hӧfliger Modu-C MS unit is designed for late clinical phase and commercial capsule filling, and hence has a much higher capacity throughput, i.e. up to 72,000 capsules per hour,” he told in-Pharmatechnologist. Both Xcelodose-based and Harro-based capsule-filling are designed for handling highly potent APIs, he added.
The new unit allows Lonza to provide powder-in-capsule services from feasibility, early clinical phase studies, late phase clinical, and on to commercial scale, he continued, and was driven by both ongoing customer projects and general demand for such services.
“We have specific requirements for late stage clinical and commercial scale capsule filling in 2018. At the same time, we continue to see general growth in powder-in-capsule study requirements emanating from the industry’s strong powder capsule phase II pipeline.”