Analytical methods are required by the FDA in order to move promising therapeutics or vaccines into human clinical trials.
The Analytical Methods Laboratory designs, develops, supports, and transfers analytical methods for testing biotechnology-derived pharmaceutical products. These methods may be used for in-process testing, process residuals testing, product characterization, final product testing, and product stability testing, depending on the capabilities of the method.
The Analytical Methods Laboratory in the Biological Process Development Facility engages in applied research. The AML was founded in 2003 and has produced several analytical methods. Most of these methods were transferred into the BPDF-QCC for routine analytical use. Some of these methods are in the process of technical transfer to an outside facility for use in commercial production.