Well-developed analytical methods are required to characterize quality attributes of biologics. These analytical methods also help to understand the critical process parameters and to minimize their impact on accuracy and precision. Biologics analytical method development and validation could be intricate, labor-intensive, and expensive in nature. An in-depth knowledge of FDA, ICH, and regulatory expectations along with the application of advanced instrumentation is critical to developing robust, efficient, and accurate analytical methods. These methods should encompass the regulatory domains of identity, strength, purity, stability, safety, and potency of biologics at every stage of the drug development.
According to FDA, EU, ICH Q2(R1), and ICH Q14 guidelines, analytical methods are divided into two categories, compendial and Non-compendial methods. The following table shows a panel of tests that are conducted as part of the analytical method development paradigm: