Sanchez-Felix, Manuel, Burke, Matt, Chen, Hunter, Mittal, Sachin and Patterson, Claire (2020) Predicting Bioavailability of Monoclonal Antibodies after Subcutaneous Administration: Open Innovation Challenge. Advanced drug delivery reviews.

Abstract

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. In this paper, we assess the current landscape in SC bioavailability prediction for mAbs and discuss the gaps and opportunities associated with bioavailability models for biotherapeutics. We also issue an open challenge to industry and academia, encouraging the development of reliable models to enable SC bioavailability prediction of therapeutic large molecules in humans and improve translation from preclinical species.

Item Type:	Article
Date Deposited:	02 Dec 2020 00:45
Last Modified:	02 Dec 2020 00:45
URI:	https://oak.novartis.com/id/eprint/42457