Pharmacokinetic (PK) Immunoassays
Monoclonal antibodies and recombinant proteins are a rapidly growing important class of targeted therapeutics. To ensure the safety and efficacy of these molecules, robust bioanalytical pharmacokinetic assays that can reliably quantify drug concentrations are required. The data from these are used to assess drug exposure and safety as well as to characterize pharmacokinetic/pharmacodynamic relationships. Immunoassays for this application need to display the utmost robustness and sensitivity, whilst being readily transferable to whatever site is carrying out the analysis.
Toxicokinetic study smoothly transferred to CRO
An immunoassay for a novel biopharmaceutical was developed to support pre-clinical toxicokinetic studies. Following assay characterisation studies performed by Fleet, the assay was smoothly transferred to the CRO performing the study, allowing a quick validation of the assay within their facilities. Fleet also provided critical reagents for the CRO's use, supplied with sufficient characterisation data and CoA documentation to allow rapid and simple implementation.
Ligand-binding assay program for biosimilar development
A development program has been commissioned from Fleet to provide ligand-binding assay methods for a range of biopharmaceuticals to support biosimilar development. These methods must be sufficiently robust and detailed that they can be easily adopted by a CRO and rapidly validated for use in a GLP environment.