Strategies for the Development of a High Throughput Octet® Bio-Layer Interferometry Method to Measure Pharmacokinetics of Monoclonal Antibodies in Preclinical Animal Models

Therapeutic antibodies are developed to treat various diseases, including cancers, immunological disorders, and infectious diseases. The safety and efficacy of these therapeutic molecules may be influenced by the way they interact with the body. Therefore, it is vital to understand how a body reacts to a biopharmaceutical after administration. Pharmacokinetic studies (PK) measure the variations of drug levels in the body as a function of time and are an essential part of the drug development process. Properly designed PK studies facilitate the determination of the proper dosage, distribution, safety, and efficacy throughout the duration of drug treatment.

Reliable and sensitive bioanalytical methods are required to quantitate drug molecules in samples collected from PK studies. ELISA or other immunoassay formats are the commonly utilized methods to analyze samples from these studies. However, developing a conventional plate-based immunoassay requires a reasonable investment of time, and additionally these assays are not high throughput for analyzing clinical samples unless the process is automated. In this application note, we evaluated the feasibility of utilizing the Bio-Layer Interferometry (BLI) platform to rapidly design, establish, and qualify a method with which to quantitate therapeutic canine antibodies from rat PK study samples to support an urgent project request.