Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs.

The development of biosimilar products is expected to grow rapidly over the next five years as a large number of approved biologics reach patent expiry. The pathway to regulatory approval requires that similarity of the biosimilar to the reference product be demonstrated through physiochemical and structural characterization, as well as within in vivo studies that compare the safety and efficacy profiles of the products. To support nonclinical and clinical studies pharmacokinetic (PK) assays are required to measure the biosimilar and reference products with comparable precision and accuracy.

Method transfer for ligand-binding assays: recommendations for best practice.

To support clinical trials, bioanalytical methods are often transferred from one laboratory to another. With the rising number of large-molecule therapeutic proteins submitted for US FDA approval, the demand for large-molecule bioanalytical support and, subsequently, method transfer increases. Ligand-binding assays are the methods most commonly used to quantify endogenous and therapeutic proteins for the assessment of biomarkers and pharmacokinetic parameters.

A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins.

Outsourcing and multi-site testing has increased for ligand binding assays supporting protein therapeutic measurement. It is common to combine and compare data across studies with data from multiple bioanalytical sites. We designed a prospective study to determine the benefits of increasing control over the transfer process to improve ruggedness.