21 Feb 2018 --- Swiss multinational, chemicals and biotechnology company, the Lonza Group is planning to expand 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, Florida, to strengthen production and bring its products to market faster.
A new suite will also be added that facilitates encapsulation of highly potent compounds. The company says that expanding its capabilities into commercial-scale encapsulation responds to its customers' desire to maintain programs at the Florida site from clinical development to commercialization.
The specialized drum-dosing technology is used for powder-in-capsule (PIC) filling for oral solid dosage forms including dry powder inhaler (DPI) applications. Lonza says the Harro unit expansion is on track for completion by the end of 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 leadership 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 expected to be completed by May and plan to broaden Lonza’s capabilities for the handling of highly potent active pharmaceutical ingredients (HPAPIs).
“Our integrated full-service offering can reduce drug development timelines, complexity and costs, which are priorities for our customers,” said Robert Beland, Site Head for Lonza Tampa. “The Tampa site is well known for exceptional capabilities in Xcelodose-based encapsulation, inclusive of highly potent compound applications. The addition of the new Harro unit allows us to offer our customers the option of one partner from concept to market for their encapsulated drug products.”
The Tampa site already has industry-leading 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.
This site hosts both developmental and cGMP Xcelodose units with the 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.
“We listen to our customers’ needs and invest accordingly,” added Gordon Bates, Head of Chemical Division, Lonza Pharma & Biotech. “Expanding our capability into commercial-scale encapsulation responds to our customers’ desire to maintain programs at the site from clinical development to commercialization.”
Earlier this year when Lonza published its “record-breaking” 2017 full-year results, it described 2017 as a “major transformational year” for the company, strengthening its positions as a world leader in pharmaceutical, biotech and specialty ingredients markets.
And earlier this month, Marco Gossen, Business Development Manager at Lonza, looked at product development and untapped opportunities for L-Carnitine during a NutritionInsight webinar.
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