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European Biopharmaceutical Review

Applying Affimers

Pharmacokinetic (PK) assays are a key component of drug development and clinical follow-up processes, with the global PK assay service market currently valued at US $652.8 million (1). Results from PK assays are critical in all phases of drug development, and numerous decisionmaking milestones in drug development programmes rely, at least in part, on PK assay results and the exposure-response relationships based on pharmacodynamic (PD) endpoints or clinical endpoints. Companies are increasingly using data from drug monitoring assays at all stages of the development pipeline to enhance the productivity and efficiency of new drug development processes (2).

Both PK and PD assays require critical reagents (eg, anti-drug reagents/anti-idiotypic binders) that can specifically and accurately measure the drug in plasma and tissues. Sensitive and reproducible PK assays are required as part of the complex and lengthy development process for new therapeutic molecules. These drug monitoring assays must be well-characterised, fully validated, and documented to yield reliable results compliant with the necessary regulatory standards.

Antibodies currently represent the ‘gold standard’ of affinity reagents, and, while traditional antibodies have been refined to the point where they are specific, sensitive, and reasonably reliable, these can be limited by development speed, complexity to produce on an industrial scale, and lotto- lot variation in assay performance.

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Dr Amanda Nicholl is Senior Assay Development Scientist at Avacta, where she applies her experience in molecular and cellular biology in both academic and industrial environments to develop assays and generate data to exemplify the use of affimer technology.
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Dr Amanda Nicholl
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