Application of GDFSS Tools to the Oxidation of a Peptide Containing Multiple Cysteine Residues

摘要

For many businesses, success and growth are measured not just by formulating quality products, but by how efficient they are at launching new products. The strategy and tools utilized during research and development directly impact the success of a product's launch. Chemical Design for Six Sigma (CDFSS) provides the methodology needed to build customer requirements into every aspect of the development process [1,2]. This systematic approach uses statistical tools to align an organization's goals with their customer's expectations by consistently providing reliable and manufacturable products in a reasonable time. Understanding the customer's expectations and correctly implementing CDFSS tools will increase the likelihood of overall success. In an effort to meet the demands of a current Customer, Six Sigma tools were applied to optimize the oxidation of a peptide containing multiple cysteine residues. Tools including process maps, cause and effect (C&E) matrices, failure mode and effect analysis (FMEA) and design of experiments (DOE), as they relate to the oxidation, are outlined in this paper.