Subcutaneous Biopharmaceutics: Building tools for a flexible future

Abstract

The major biopharmaceutics challenge faced during the development of subcutaneous (SC) drug products is the limited understanding of the physiological factors and the combination product attributes that can impact absorption rate/extent and drug product performance. Currently, the biopharmaceutics toolkit available to characterize and predict SC in vivo performance is immature compared to that of oral delivery, resulting in conservative bioequivalence (BE) strategies and costly clinical studies to manage even modest drug product changes during clinical development. This abstract summarises the development of novel SC Biopharmaceutics tools, the approaches we are taking to characterise and predict SC drug product performance and the questions we would still like to investigate. We are pursuing a strategy centred on a best-in-industry in-silico model, and driving improvements in dosing characterisation and in-vitro methods to build holistic understanding. 

Keywords

Biopharmaceutic tools, Subcutaneous administration, PBBM, safe space, Biopharmaceutics tools, subcutaneous administration

How to Cite

Harris, K. L., Wood, J. M., Gonzalez, L. G., Todd, S. & Grant, I., (2023) “Subcutaneous Biopharmaceutics: Building tools for a flexible future”, British Journal of Pharmacy 8(2). doi: https://doi.org/10.5920/bjpharm.1402

101

Views

22

Downloads

Share

Authors

Kate Louise Harris (Astrazeneca)
J Matthew Wood (Astrazeneca)
Laura Garcia Gonzalez
Simon Todd
Iain Grant

Download

Issue

Dates

Licence

Creative Commons Attribution 4.0

Identifiers

Peer Review

This article has been peer reviewed.

File Checksums (MD5)

  • Fulltext: a29228642127e364a83d2000c71bab58