Chapter 4 - Analytical quality by design for size-exclusion chromatography

Abstract

The analytical quality by design (A-QbD) approach includes the concept of practical use of QbD into the development of analytical methods. Nowadays, because of the robustness of method, the pharmaceutical and biotech companies have shown much consideration over A-QbD as compared to the conventional approaches. Moreover, the implementation of A-QbD by the pharmaceutical and biotech industries has become a trend for process and method development to regulate the risk management and maintain the quality of products. Moreover, the application of A-QbD in chromatographic techniques such as size-exclusion chromatography (SEC) has increased the quality and yield of products. SEC is one of the most prevalent methods used to separate, measure, and quantify the average molecular weight of various products, mostly macromolecules. In combination, SEC and A-QbD have been used as a vital analytical approach for characterization and quantification of various types of bio-macromolecules. In this chapter, we have summarized various A-QbD-based approaches used in the establishment of SEC parameters for effective quantification and assessment of pharmaceutical products or biologicals.