Lonza Expands Product Lifecycle Management Capabilities

On Sept. 20, 2018, Lonza announced the addition of two new Ibex Solutions offerings to its 100,000-m2 (1.1 million- ft2) biopark in Visp, Switzerland, with an investment of CHF 400-million (US$416-million). The two new solutions, Ibex Design and Ibex Develop, which will become operational starting in 2020, are designed to meet the evolving needs of biotech companies with antibody therapies, from the preclinical stage through to commercialization. The new investment allows Lonza to offer complete product lifecycle management in one site.

Ibex Dedicate, a modular, technology-agnostic biomanufacturing concept, was launched in July 2017 as the first solution offering under the Ibex name. Ibex Dedicate offers an innovative facility concept with reduced capital expenditure and accelerated timelines, enabling speed-to-market or allowing biopharma companies to delay investment decisions to decrease financial risk, Lonza reports.

Ibex Design covers the early stages of creating a new biologic, from gene through to clinical Phase I, allowing aspiring companies to start clinical trials earlier while reducing uncertainty. The offering comprises a fixed-price gene-to-vial package with terms under which Lonza will deliver drug product based on at least 1-kg drug substance within 12 months. The package also includes the reservation of a manufacturing slot for clinical resupply.

According to Lonza, Ibex Develop helps companies seamlessly and rapidly transition from clinical Phase II to commercialization, enabling submission of biologics license applications within 22 months from the start of process characterization. This is expected to accelerate the path-to-market by eliminating the need for tech transfers, allowing process optimizations, and creating operational efficiencies.

The two new offerings draw on the company’s more-than 30-years’ R&D and operational experience in biomanufacturing. Platform technologies, such as the GS Gene Expression System and expertise in drug product development, are an integral part of the new offerings. The application of single-use technologies and a high degree of automation further increase the efficiency of these new offerings. In addition, altogether, the three Ibex Solutions offer the ability to scale-up or scale-out to other sites in the established Lonza network in Europe, America, or Asia.

“We looked at every step in the development and manufacturing process and asked how we could transform the path to commercialization for customers,” said Marc Funk, COO of Lonza Pharma & Biotech, in a company press release. “The result strengthens our capabilities from the early stages of drug development all the way through to commercialization. It will help biotech companies deliver life-saving medicines to patients faster.”

Source: Lonza