In:
Bioanalysis, Future Science Ltd, Vol. 13, No. 10 ( 2021-05), p. 817-827
Abstract:
Background: High-quality critical reagents are essential to the successful support of biotherapeutic drug development regardless of the analytical platform used for support. The lack of such a reagent, early in the development lifecycle of a biotherapeutic can have detrimental impact on resource and translation of data across development phases. Results: Here, a pharmacokinetic assay case study is shared that illustrates what can occur when there is a lack of a reproducible and sustainable critical reagent early in the development lifecycle of a biotherapeutic. Various assay formats and critical reagents, as well as reagents generation programs, were initiated to find a reagent and assay format which was fit for purpose. Conclusions: Identification of appropriate critical reagents early in the development lifecycle of a biotherapeutic as advantageous.
Type of Medium:
Online Resource
ISSN:
1757-6180
,
1757-6199
DOI:
10.4155/bio-2020-0253
Language:
English
Publisher:
Future Science Ltd
Publication Date:
2021
SSG:
15,3
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