Analytical techniques used in the development of quantitative and qualitative assays for pharmaceutical and biological products in animal health

Abstract

The animal health industry is a growing industry. Owners of pets and other animals want to ensure their animals are healthy. To do this, the animal health industry markets a variety of products from pharmaceutical products, such as antibiotics, to biological products, such as vaccines. These products are developed and marketed after the company provides regulators the necessary information as guided by a set of regulations. Pharmaceutical products follow Title 21 of the Code of Federal Regulations, while biological products follow Title 9 of the Code of Federal Regulations. During the product development process as well as after marketing, regardless of the regulations to follow, each product must go through testing for efficacy, safety, potency, and stability. The regulatory guidelines provide direction to companies on expectations of the testing requirements for each type of product. Different analytical techniques are used to provide the necessary data in support of product development. Discussed in this report, two analytical techniques are well known in the industry, and one is quickly becoming a technique of great value. Mass spectrometry, coupled with liquid chromatography, is an industry standard for testing product potency and purity as well as pharmacokinetics. The enzyme-linked immunosorbent assay (ELISA) is also used to measure potency of products as well as product stability. The newest technique is flow cytometry that characterizes cells within a suspension, most often with the use of cellular biomarkers as targets. By understanding the application of each technique as well as how it relates to regulatory requirements, the industry can provide assurances to regulators that their products are safe and efficacious for the treatment and/or prevention of animal diseases. This report outlines the history, theory, and use of three different analytical techniques currently used for pharmaceutical and biological products in animal health.