Presentation Description: Despite the increasing trend towards subcutaneous (SC) delivery of monoclonal antibodies (mAbs), factors influencing the SC bioavailability of mAbs remain poorly understood. To address critical knowledge gaps and issues during development of SC dosage forms for mAbs, the SC Drug Delivery and Development Consortium was convened in 2018 as a pre-competitive collaboration of recognized industry experts. One of the Consortium’s eight problem statements highlights the challenges of predicting human bioavailability of subcutaneously administered mAbs due to a lack of reliable in vitro and preclinical in vivo predictive models. Our recent publication in ADDR captures the current landscape in SC bioavailability prediction for mAbs and discusses the gaps and opportunities associated with bioavailability models for biotherapeutics. The bioavailability subteam at the consortium issues an open challenge to industry/ academia, encouraging the development of reliable preclinical models to improve prediction and translation of SC bioavailability of mAbs to humans.
Acknowledging why the understanding of bioavailability of subcutaneously administered monoclonal antibodies is important
Describe the lack of predictability of in vivo, in vitro and in silico models for SC bioavailability of mAbs and Impact
Understand the pre-competitive opportunity for building fundamental understanding and predictive models