We usually talk about practical tips, best practices, and such but today I want to point you toward an interesting commentary article about an exciting 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, which was first developed in their lab. It also examines the advantages, regulatory considerations, limitations, and obstacles of the approach and possible ways to overcome these 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 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, as well as allowing action to be taken to direct production of the desired biotherapeutic product. Conveniently this subject leads into the next handful of blog posts where we’ll look at spent media analysis using HILIC LC/MS, and reveal tips to achieve the best possible results. Hope to see you back for that!
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