Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
This is our annual review of new liquid chromatography (LC) columns and accessories introduced at Pittcon and throughout the previous year. This year, Michael Swartz, former author of our "Innovations in HPLC" and "Validation Viewpoint" columns, steps in as a guest columnist to write the review.
Over the course of a drug product's life (as much as 15-20 years or more) many significant advances in technology will occur. Implementing new analytical techniques (for example, capillary electrophoresis), or advances in existing technology (for example, sub-2-μm liquid chromatography [LC]) can significantly impact business practices (return on investment) and product quality. However, in a regulated laboratory, implementing new technology can present many challenges.
Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:Contains practical, up-to-date guidelines for analyti
Advances in ion chromatography (IC) technology have extende its application far beyond simple inorganic anions and cations since it was first practiced in 1975. Improvements in column chemistries and suppression, eluent generation, and instrumentation has extended the reach of IC to the analysis of organic acids, carbohydrates, sugar alcohols, aminoglycosides, amino acids, proteins, glycoproteins, and many other analytes. In this installment of "Innovations in HPLC," in collaboration with Phillip DeLand and Rosanne Slingsby of Dionex Corporation, I'II review some of the basics of IC and discuss some recent advances in IC that extend this technology to new applications.
Biopharmaceutical or biotechnology derived pharmaceuticals have become more and more apparent in the marketplace, and the industry continues to grow and thrive. More and more firms are becoming involved in discovering and introducing proprietary biopharmaceuticals or biogenerics or biosimilars. This month's installment of "Validation Viewpoint" attempts to summarize the current situation with regard to method validation of biopharmaceuticals, mainly as protein products, quite often as glycoproteins. We discuss the roles of FDA, ICH, USP, and others in formulating and prescribing analytical method validation requirements for biopharmaceuticals.
