Whether it is measuring the concentration of a biologic and its target in a human matrix or characterizing anti-drug antibodies from a clinical trial, the responsibility of generating meaningful, clinically relevant assay data lies with the bioanalytical scientist.

Analyzing samples collected from subjects participating in clinical trials is crucial to the clinical trial process. Bioanalysis of these samples provides essential data on various endpoints to assess the pharmacokinetic (PK) profile of large molecule investigational medicinal products and monitor their safety and efficacy. Further, sample analysis or evaluation must be performed per acceptable standards. This ensures the data reported is reliable, accurate, and safe for patients.

To ensure quality data, any large molecule bioanalytical team needs to develop and validate fit-for-purpose immunoassays compliant with good laboratory practices (GLP) or good clinical laboratory practices (GCLP) – so that the data generated is meaningful to clinicians for further investigations and correlation.

In this viewpoint article, we discuss how to establish the connection between clinical and bioanalytical teams to ensure successful outcomes of GLP/GCLP large molecule bioanalytical (BA) sample analysis.