Analytical control strategy for biologics. Part I: Foundations

Biologic therapeutics encompass different modalities with vastly different molecular profiles. Despite these differences, all products follow a similar approach to Pharmaceutical Development, which includes an integrated control strategy that relies on a clinical target product profile (TPP), a qual...

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Bibliographic Details
Published in:	Journal of pharmaceutical sciences 2025-07, Vol.114 (7), p.103826, Article 103826
Main Authors:	Kendrick, Brent S., Sampathkumar, Krishnan, Gabrielson, John P., Ren, Da
Format:	Article
Language:	English
Subjects:	Analytical method development Analytical method validation Analytical target profile Biological Products - analysis Biological Products - chemistry Biological Products - standards Biologics Control strategy Drug Development - methods Drug Development - standards Formulation robustness Humans Method qualification Monoclonal antibodies QBD Quality Control Quality target product profile
Citations:	Items that this one cites
Online Access:	Get full text
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