Lonza Expands Encapsulation and HPAPI Capabilities in North America
Lonza is expanding its late-stage clinical and commercial encapsulation capabilities for solid-oral and inhaled dosage forms in North America.
As part of the expansion, the company will install a new Modu-C MS encapsulation unit (Harro unit) from Harro Hӧfliger, a German packaging company, at its product-development and manufacturing facility in Tampa, Florida, to strengthen its product-development acceleration. Lonza gained the site as part of its $5.5-billion acquisition of Capsugel in 2017.
The drum-dosing technology is used for powder-in-capsule (PIC) filling for oral solid-dosage forms, including dry-powder inhaler applications. Installation and validation of the Harro unit are on track to be completed in February 2018.
The investment adds to Lonza’s product-development capabilities and capacity to support process development, clinical trial, and commercial-scale manufacturing using encapsulation. In addition, the investment adds to Lonza’s industry experience with PIC studies as an addition to the company’s proprietary Xcelodose Precision Powder Micro-Dosing Systems.
In addition, a new dispensing area and two new processing suites are anticipated to be completed by May 2018 that Lonza says will broaden its capabilities for handling highly potent active pharmaceutical ingredients.
The Tampa site already has Xcelodose capacity and experience as teams there have completed more than 600 PIC programs across more than 200 compounds, according to the company. This site hosts both developmental and cGMP Xcelodose units with capability to produce more than 15,000 capsules/day for a given product, including highly potent compounds. Lonza says the new Harro unit can fill more than 72,000 capsules per hour.