Open AccessCritical reagents for ligand-binding assays: process development methodologies to enable high-quality reagents
Author(s) -
Caroline Kittinger,
Jared A. Delmar,
Lisa Hewitt,
Rebecca Holcomb,
Christopher R. Jones,
Hayden Jones,
Robert Kubiak,
Nancy Lee,
L Claire McClenny,
Neil Mody,
Ellen O'Connor
Publication year - 2022
Publication title -
bioanalysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.566
H-Index - 58
eISSN - 1757-6199
pISSN - 1757-6180
DOI - 10.4155/bio-2021-0217
Subject(s) - reagent , combinatorial chemistry , chemistry , process development , immunogenicity , conjugated system , drug development , process (computing) , computer science , drug , pharmacology , process engineering , antigen , organic chemistry , medicine , immunology , engineering , operating system , polymer
Development of biotherapeutics require pharmacokinetic/pharmacodynamic (PK/PD) and immunogenicity assays that are frequently in a ligand-binding assay (LBA) format. Conjugated critical reagents for LBAs are generated conjugation of the biotherapeutic drug or anti-drug molecule with a label. Since conjugated critical reagent quality impacts LBA performance, control of the generation process is essential. Our perspective is that process development methodologies should be integrated into critical reagent production to understand the impact of conjugation reactions, purification techniques and formulation conditions on the quality of the reagent. In this article, case studies highlight our approach to developing process conditions for different molecular classes of critical reagents including antibodies and a peptide. This development approach can be applied to the generation of future conjugated critical reagents.