Analytical methods are used at every stage of pharmaceutical or biological therapeutic life cycle, be it drug discovery, drug development, clinical trial analysis, or post market lot release testing. New analytical methods are continuously being developed but at the same time, other methods have been around for over a hundreds years. For example, a technique invented in 1935, Karl Fischer moisture analysis, is a very common technique still used everyday in pharmaceutical QC labs. pH measure methods were first developed in the 1910’s and in 1899 Wilhelm Wien constructed the first mass spectrometer that could separated gas discharges based on their charge to mass ratios. However, new techniques are being developed faster than ever before. Electrochemiluminescence, single molecule detection methods, high resolution mass spectrometers and microarray technologies are at the forefront of modern analytical developments.
Many of the techniques listed below are used at specific stages of the product life cycle. For example, the common QC analytical methods such as Karl Fisher moisture analysis would not be a technique used during drug discovery, but would be a technique used during drug development and as a lot release test. This list is not meant to be all inclusive. Because PBL does not perform any DNA or RNA work, PCR and other DNA analytical methods are intentionally left out. In addition, new drug discovery platforms are continually being developed by emerging and established biotechnology companies and therefore it would be difficult, even impossible, to provide a comprehensive list of all drug discovery analytical methods. The list of analytical techniques below are all employed by PBL and are commonly used to test both large and small molecules.
List of Analytical Methods Used for Pharmaceuticals and Biologics
Enzyme-Linked Immunosorbent Assay – ELISA
Gas Chromatography – GC and GC-MS
High Pressure Liquid Chromatography – HPLC
Inductively Coupled Plasma Mass Spectrometry – ICP-MS
Karl Fischer Moisture Analysis
Liquid Chromatography Mass Spectromety – LC-MS and LC-MS/MS