Meet-the-Member: Lonza’s accelerated end-to-end process development for monoclonal antibodies

The exchange of ideas among our members is one of the central tasks of our association's work. We are frequently asked to offer a non-binding, digital and regular exchange format. To this end, we are now launching a pilot series in autumn. Each of the 60-minute webinars will start with a ten-minute impulse and then offer the opportunity to enter into a detailed exchange with the expert giving the presentation or to hold general discussions and make contacts in one of the other small groups.

This is the current link to participate: https://us06web.zoom.us

The current webinar is presented by

Lonza recently developed a new accelerated workflow for the development of monoclonal antibodies. As a result, antibody drug product is now available to Lonza’s customer within less than 12 months from DNA sequence availability to IND submission. The new workflow was built on three key elements: parallel cell line and process development, best-in-class platform processes and co-location of the main development and GMP manufacturing steps. To save time, early material generated from non-clonal cells is used to develop the purification process and supply sufficient material for formulation development. Consequently, fully developed drug substance and drug product processes are available very early in the workflow and non-GMP material to supply tox studies is generated while the GMP production campaign is initiated. Lonza scientists and engineers leveraged the process knowledge gained during the past decades to combine all the enabling technologies into this new accelerated end-to-end process. They also relied on the extensive data set generated over time to offer robust and reliable development strategies that result in stable clonal cell lines, expected product quality attributes and robust process control strategies. The resulting processes for drug substance and drug product manufacturing are developed within short timelines while ensuring the highest quality standards. In addition, the process is designed to support not only early clinical development, it is also matching expectations for late phase development and manufacturing at any production scale that may be needed subsequently.