Anti-idiotypic binders validated in regulatory bioanalysis assay by Covance

Antibodies have long represented the ‘gold standard’ for regulatory bioanalysis of therapeutic proteins. Yet, they are associated with a number of limitations, including development time, manufacturing complexity and lack of batch reproducibility. 

Our new application note details Covance’s validation to regulatory standards of an anti-idiotypic Affimer binder to Trastuzumab as part of a bioanalytical assay. Here Covance demonstrated the validity of Affimer binders as alternative or complimentary reagents to traditional antibodies within regulated PK assays, showing:

• Accurate and sensitive quantification of the target therapeutic within disease state matrix
• Improved dynamic range compared to current antibody-based assays
• Excellent lot-to-lot reproducibility, reducing assay standardisation
• Full development of the Affimer binder within 3 months

Download the application note by completing the form.

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