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A new suite for the encapsulation of highly potent drugs will be added.
Lonza announced on Feb. 20, 2018 that it is expanding its late-stage clinical and commercial encapsulation capabilities for solid oral and inhaled dosage forms in North America. A new Harro HÓ§fliger Modu-C MS encapsulation unit will be installed at the company’s integrated product development and manufacturing facility in Tampa, FL to further strengthen its speed-to-market capabilities. Installation and validation of the encapsulation unit are expected to be completed by February 2018.
The specialized drum-dosing technology is used for powder-in-capsule (PIC) filling for oral solid-dosage forms including dry powder inhaler (DPI) applications. The investment complements Lonza’s Xcelodose Precision Powder Micro-Dosing Systems, both of which are key components in the company’s toolkit for accelerated product development.
A new dispensing area and two new processing suites are anticipated to be completed by May 2018, which will broaden Lonza’s capabilities for the handling of highly potent APIs.
With the Xcelodose capacity and expertise, the teams at the Tampa site have completed more than 600 PIC programs for more than 200 compounds, which has resulted in a set of best practices for handling PIC challenges. The 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. The addition of the new Harro HÓ§fliger Modu-C MS encapsulation unit will boost operational capacity as it can fill more than 72,000 capsules per hour.