Intact protein LC–MS for pharmacokinetics

Biography: John Kellie is currently a GlaxoSmithKline (GSK) fellow in the Bioanalysis, Immunogenicity, and Biomarkers group at GSK. John received his B.Sc. in Biochemistry from Indiana University (USA) and his PhD in Chemistry from Northwestern University (USA) studying under Dr Neil Kelleher. He was a post-doctoral scientist at Eli Lilly and Company, where he developed methods for intact protein quantitation of a Parkinson’s Disease biomarker from human brain tissue. At GSK, John utilizes mass spectrometry for development of novel bioanalytical methods for biotherapeutic and protein quantitation from pre-clinical and clinical samples, with a focus on intact protein and large mass quantitation for pharmacokinetics, catabolism, biotransformation and product quality attribute support. John Kellie speaks to the International Journal of Pharmacokinetics about intact protein LC–MS for pharmacokinetic application.

Managing product development resources through the use of product quality attribute mapping

A technique using product quality attribute mapping to assist product resourcing decisions is described. Primary data from respondents via quantitative questionnaire surveys of four different industrial manufacturing companies were collected and analysed. Care was taken with the data source and type of scales employed to ensure meaningful comparisons could be made. The first objective of the data analysis was to determine the importance of each of the companies' customers. This was followed by determining the importance of the product attributes to each customer. An overall perception of product attribute importance was obtained by combining the customer importance with the importance of product attributes. The respondents' perceptions of the competitive situation was then combined with the overall perception of product attribute importance to give a quality index for each product attribute. The derived picture product attributes relative to one another are shown by bubble maps indicating the position of the competitive index against attribute importance, with the quality index represented by the bubble size. The significance of these bubble maps, particularly in relation to resourcing decisions for the companies, is discussed. It is concluded that companies can use data in this form to guide product development in a quantifiable manner.