We usually talk about practical tips, and best practices, and such, but today I want to point you toward an interesting commentary article on an interesting and challenging new direction for peptide mapping workflows. Multi attribute methods (MAM) use peptide mapping techniques to simultaneously monitor both peptide sequence and any number of product related impurities, from amino acid substitutions to glycosylation, deamidations, and other post-translational modifications (PTMs).
This commentary by Rogers et al discusses the MAM approach first developed in their lab – the advantages, regulatory considerations, limitations, obstacles, and possible ways to overcome those obstacles.
Here’s the commentary article:
Rogers, R.S.; Abernathy, M.; Richardson, D.D.; Rouse, J.C.; Sperry, J.B.; Swann, P.; Wypych, J.; Yu, C.; Zang, L.; Deshpande, R. A view on the importance of “Multi-Attribute Method” for measuring purity of biopharmaceuticals and improving overall control strategy. The AAPS Journal, 2017.
Here’s the original publication of the workflow:
Rogers, R.S.; Nightlinger, N.S.; Livingston, B.; Campbell, P.; Bailey, R.; Balland, A. et al. Multi-attribute method for characterization, quality control testing, and disposition of biologics. MAbs. 2015.
Cited in the commentary paper are a couple of exciting examples of directly controlling the glycosylation of the biotherapeutic by controlling levels of specific cell culture process parameters. Near-real time LC/MS measurements of both the biotherapeutic product and the spent media allowed the correlations to be made and action taken to direct production of the desired biotherapeutic product. Conveniently that leads into the next handful of blog posts where we’ll look at spent media analysis using HILIC LC/MS, and tips to achieve the best possible results. Hope to see you back for that!
Anne
Keywords: Bio columns, liquid chromatography, peptide mapping, multi attribute methods, literature, AdvanceBio blog
