Lonza announced the expansion of its late-stage clinical and commercial encapsulation capabilities for solid oral and inhaled dosage forms in North America. The company will install a new Harro Hӧfliger Modu-C MS encapsulation unit (Harro unit) at its integrated product development and manufacturing facility in Tampa, FL to strengthen further its speed-to-market capabilities.
The specialized drum-dosing technology is used for powder-in-capsule (PIC) filling for oral solid dosage forms including dry powder inhaler (DPI) applications. Installation and validation of the Harro unit are on track to be completed this month.
The investment strengthens Lonza’s full-service product-development capabilities and capacity to support process development, clinical trial and commercial scale manufacturing utilizing encapsulation. It also complements Lonza’s industry participation in PIC studies based on the company’s Xcelodose Precision Powder Micro-Dosing Systems. The Harro unit and the Xcelodose system are key components in Lonza’s toolkit for accelerated product development.
In addition, a new dispensing area and two new processing suites are anticipated to be completed by May 2018 that will broaden Lonza’s capabilities for the handling of highly potent active pharmaceutical ingredients (HPAPIs).
The Tampa site already has Xcelodose capacity and expertise as teams there have completed more than 600 PIC programs across 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 unit will boost operational capacity as it can fill more than 72,000 capsules per hour.
(Source: Lonza Pharma & Biotech)