The Analytical Methods Laboratory (AML) 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 develops analytical methods to monitor the quality, quantity, stability, and purity of recombinant proteins. Specific, accurate, and reproducible analytical methods are critical to enable progress in fermentation development and purification development. Analytical methods are required by the FDA in order to move promising therapeutics or vaccines into human clinical trials. The AML was founded in 2003. It has grown from a staff of one to a staff of six in 2005. During its short history, the AML has produced 20 analytical methods and continues to produce more. 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.