Willis, L.F. orcid.org/0000-0001-6616-3716, Trayton, I., Saunders, J.C. et al. (11 more authors) (2025) Rationalising mAb candidate screening using a single holistic developability parameter. Molecular Pharmaceutics, 22 (1). pp. 181-195. ISSN 1543-8384
Abstract
A framework for the rational selection of a minimal suite of nondegenerate developability assays (DAs) that maximize insight into candidate developability or storage stability is lacking. To address this, we subjected nine formulation:mAbs to 12 mechanistically distinct DAs together with measurement of their accelerated and long-term storage stability. We show that it is possible to identify a reduced set of key variables from this suite of DAs by using orthogonal statistical methods. We exemplify our approach by predicting the rank formulation:mAb degradation rate at 25 °C (determined over 6 months) using just five DAs that can be measured in less than 1 day, spanning a range of physicochemical features. Implementing such approaches focuses on resources, thus increasing sustainability and decreasing development costs.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2024 The Authors. Published by American Chemical Society. This publication is licensed under CC-BY 4.0. |
Keywords: | antibody; developability assessment; formulation; protein aggregation; kinetic stability |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Biological Sciences (Leeds) > School of Molecular and Cellular Biology (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 06 Dec 2024 11:29 |
Last Modified: | 24 Jan 2025 12:40 |
Status: | Published |
Publisher: | American Chemical Society |
Identification Number: | 10.1021/acs.molpharmaceut.4c00829 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:220534 |