Complete product lifecycle management in one location

Lonza expansion includes drug substance development, and drug substance and drug product manufacturing.

The two new Ibex Solutions, Ibex Design and Ibex Develop, announced today are designed to meet the evolving needs of biotech companies with antibody therapies, from the preclinical stage through to commercialization. Together with Ibex Dedicate, the new investment allows Lonza to offer complete product lifecycle management in one site.

Ibex Design covers the early stages of creating a new biologic, from gene through to clinical phase I. The offering comprises a pioneering 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. Ibex Design allows aspiring companies to start clinical trials earlier while reducing uncertainty.

Ibex Develop helps companies seamlessly and rapidly transition from clinical Phase II to commercialization. The offering enables biologics license applications (BLAs) to be submitted within 22 months from the start of process characterization. Eliminating the need for tech transfers, allowing process optimizations and creating operational efficiencies are expected to accelerate the path to market.

Ibex Design and Ibex Develop draw on Lonza’s R&D and operational experience from more than 30 years in biomanufacturing. Proven 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 Ibex Design and Ibex Develop. In addition, customers of all three Ibex Solutions can benefit from 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 Lonza Pharma & Biotech. “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.”

Ibex Design and Ibex Develop will become operational from 2020 and provide a full range of manufacturing options from early development through to full commercialization.