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Whitepaper: Bioanalytical support in the development of biologics

1 April 2016  •  Author(s): Chimera Biotec

Whitepaper - Chimera Biotec - April 2016Therapeutic antibodies and other biotherapeutic macromolecule drugs (Biologics) often pose challenges in bioanalytical support. Safety and potency considerations frequently demand low dosing in dose-escalation trials and in consequence very sensitive ligand-binding assays (LBA) for PK support, even at late time points and despite fast drug clearance. In addition a broad assay range with high upper limit of quantification is particularly favorable to cover PK analytics at early time points, for high dosing or during Tox evaluation. Ideally a bioanalytical method covers the full drug concentration range to enable PK profiling during the complete drug development program. 

In this publication Imperacer® case studies demonstrate the advantage of broad assay range combined with excellent sensitivity for several Biologics on their way from R&D to clinics.

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2 responses to “Whitepaper: Bioanalytical support in the development of biologics”

  1. Ali Mehramizi says:

    Please let me have this article

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