Lonza Expands Encapsulation and HPAPI Capabilities in North America
Lonza today 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 (USA), 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 by February 2018.
The investment strengthens Lonza’s full-service product-development capabilities and capacity to support process development, clinical trial and commercial scale manufacturing utilizing encapsulation. In addition, the investment 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 anticipated to be completed by May 2018 that will 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 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,” said 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.”
H7N9 Influenza Vaccine Clinical Trials CommenceNews
Two new clinical trials testing an experimental vaccine to prevent influenza caused by an H7N9 influenza virus are now enrolling volunteers at sites across the United States. The Phase 2 studies will test different dosages of the inactivated influenza vaccine candidate as well as different vaccination schedules. The studies also will evaluate whether an adjuvant boosts the immune responses of people receiving the vaccine.
Researchers Fine-Tune Computer-Assisted Drug Repositioning Process to Treat Rare DiseasesNews
Researchers at the LSU Computational Systems Biology group have developed a sophisticated and systematic way to identify existing drugs that can be repositioned to treat a rare disease or condition.READ MORE
Study Extends Potential of Personalized Cell-based ImmunotherapiesNews
New methods developed for the study could be applied to devise personalized, cell-based immunotherapies for epithelial ovarian cancer or other types of tumorsREAD MORE