Thomas Rohrer
Lonza Pharma & Biotech, USA
Title: Developing and manufacturing the next generation of bioconjugates
Biography
Biography: Thomas Rohrer
Abstract
Advances in the coupling of antibodies to potent cytotoxic drugs have resulted in stable delivery platforms with improved pharmacokinetics, which spares patients from the debilitating systemic toxicity observed with traditional chemotherapy. Two ADCs Adcetris® (brentuximab vedotin) and Kadcyla (trastuzumab emtansine) are currently approved for difficult -to-treat therapeutic indications. Currently three more ADCs, Inotuzumab ozogamicin (Pfizer),Vadastuximab talirane (Seattle Genetics) and Depatuxizumab mafodotin (AbbVie) are undergoing regulatory review or completing Phase III clinical studies. In all, more than 60 ADCs are in clinical trails with over 100 more in the pipeline. In addition to ADCs the multi-faceted field of bioconjugates also extends to coupling targeting agents to non-cytotoxic payloads. Perserving the targeting ability of antibody and the effector function of the payloads require that process R&D find the intersection of reaction parameters which preserve the integrity of both molities. Case studies will be presented which discuss the development and manufacturing of several next generation bioconjugates.