Search

The multi-attribute method (MAM) was conceived as a single assay to potentially replace multiple single-attribute assays that have long been used in process development and quality control (QC) for protein therapeutics. MAM is rooted in traditional peptide mapping methods; it leverages mass spectrometry (MS) detection for confident identification and quantitation of many types of protein attributes that may be targeted for monitoring. While MAM has been widely explored across the industry, it has yet to gain a strong foothold within QC laboratories as a replacement method for established orthogonal platforms. Members of the MAM consortium recently undertook an interlaboratory study to evaluate the industry-wide status of MAM. Here we present the results of this study as they pertain to the targeted attribute analytics component of MAM, including investigation into the sources of variability between laboratories and comparison of MAM data to orthogonal methods. These results are made available with an eye toward aiding the community in further optimizing the method to enable its more frequent use in the QC environment.

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 purity-indicating 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.

Biogeographic interpretation of large-scale phytoplankton distribution patterns in relation to surface hydrography is essential to understanding pelagic food web dynamics and biogeochemical processes influencing global climate. We examined the abundance and biomass of phytoplankton in relation to physical and chemical parameters in the southeast Pacific Ocean. Samples were collected along longitude 110°W, between 10°N and 60°S during late austral summer. Patterns of taxa abundance and hydrographic variables were interpreted by principal components analysis. Five distinct phytohydrographic regions were identified: (i) a north equatorial region of moderate productivity dominated by small flagellates, low nitrate and low-to-moderate p CO 2 ; (ii) a south equatorial region characterized by high primary productivity dominated by diatoms, high nutrient levels, and relatively high p CO 2 ; (iii) a central gyre region characterized by low productivity dominated by small flagellates, low nitrate, and high p CO 2 ; (iv) a sub-Antarctic region with moderate productivity dominated by coccolithophores, moderate nitrate concentrations, and low p CO 2 ; and (v) an Antarctic region with high productivity dominated by diatoms, very high nitrate, and low p CO 2 . Productivity and average phytoplankton cell size were positively correlated with nitrate concentration. Total phytoplankton abundance was negatively correlated with p CO 2 , photosynthetically active radiation, and ultraviolet-B radiation. The interaction between phytoplankton carbon assimilation, atmospheric CO2, and the inhibitory effect of ultraviolet radiation could have implications for the global climate. These data suggest that the effects would be greatest at southern mid-latitudes (40–50°S) where present phytoplankton production and predicted future increases in UV-B are both relatively high.