Journal
JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY
Volume 32, Issue 4, Pages 913-928Publisher
AMER CHEMICAL SOC
DOI: 10.1021/jasms.0c00415
Keywords
multi-attribute method; MAM Consortium; new peak detection; NISTmAb; purity testing
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The MAM Consortium conducted an interlaboratory study to evaluate NPD performance across the industry, with results showing representative high-resolution MS capabilities. Critical elements of NPD were identified to further refine the methodology and speed up adoption into manufacturer-specific protein therapeutic product life cycles.
The Multi-Attribute Method (MAM) Consortium was initially formed as a venue to harmonize best practices, share experiences, and generate innovative methodologies to facilitate widespread integration of the MAM platform, which is an emerging ultra-high-performance liquid chromatography-mass spectrometry application. Successful implementation of MAM as a purityindicating assay requires new peak detection (NPD) of potential process- and/or product-related impurities. The NPD interlaboratory study described herein was carried out by the MAM Consortium to report on the industry-wide performance of NPD using predigested samples of the NISTmAb Reference Material 8671. Results from 28 participating laboratories show that the NPD parameters being utilized across the industry are representative of high-resolution MS performance capabilities. Certain elements of NPD, including common sources of variability in the number of new peaks detected, that are critical to the performance of the purity function of MAM were identified in this study and are reported here as a means to further refine the methodology and accelerate adoption into manufacturer-specific protein therapeutic product life cycles.
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