Lonza Expands Ibex TM Solutions to Offer Complete Product Lifecycle Management in One Location
- CHF 400 million investment in Lonza's biopark in Visp (CH) to expand IbexTM Solutions with two innovative offerings
- The expansion includes drug substance development and drug substance and drug product manufacturing, which allows customers to manage the complete product lifecycle in one site
- Advanced technology, single-use bioreactors and improved platform processes shorten time to clinic and to market, while innovative business models will increase predictability
Basel, Switzerland, 20 September 2018 – Lonza announces the addition of two new IbexTM Solutions offerings to Lonza's 100,000 m2 (1.1 million ft2) biopark in Visp (CH). In July 2017 IbexTM Dedicate, a modular, technology-agnostic biomanufacturing concept, was launched as the first IbexTM Solutions offering. IbexTM Dedicate offers an innovative facility concept with reduced CAPEX and accelerated timelines, enabling speed to market or allowing biopharma companies to delay investment decisions to decrease financial risk.
The two new IbexTM Solutions, IbexTM Design and IbexTM 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 IbexTM Dedicate, the new investment allows Lonza to offer complete product lifecycle management in one site.
IbexTM 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. IbexTM Design allows aspiring companies to start clinical trials earlier while reducing uncertainty.
IbexTM 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.
IbexTM Design and IbexTM 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 IbexTM Design and IbexTM Develop. In addition, customers of all three IbexTM 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.”
IbexTM Design and IbexTM Develop will become operational from 2020 and provide a full range of manufacturing options from early development through to full commercialization.
Images for editorial use can be downloaded from www.ibex.lonza.com.