Protein expression profiling arrays: tools for the multiplexed high-throughput analysis of proteins

The completion of the human genome sequence has led to a rapid increase in genetic information. The invention of DNA microarrays, which allow for the parallel measurement of thousands of genes on the level of mRNA, has enabled scientists to take a more global view of biological systems. Protein microarrays have a big potential to increase the throughput of proteomic research. Microarrays of antibodies can simultaneously measure the concentration of a multitude of target proteins in a very short period of time. The ability of protein microarrays to increase the quantity of data points in small biological samples on the protein level will have a major impact on basic biological research as well as on the discovery of new drug targets and diagnostic markers. This review highlights the current status of protein expression profiling arrays, their development, applications and limitations

Industry Perspective of International Consortium for Innovation through Quality in Pharmaceutical Development: Complementary LBA and LC-MS Strategies for Large Molecule Protein Bioanalysis and Biotransformation

Increasingly diverse large molecule modalities have driven the need for complex bioanalysis involving both traditional ligand binding assays (LBA) and more recent hybrid immunoaffinity liquid chromatography-mass spectrometry (LC-MS) platforms. Given the scientific expertise in LBA and LCMS typically resides in different functions within the industry, this has presented operational challenges for an integrated approach for bioanalysis. Encouragingly, over time, the industry has recognized the complementary value. This has not been an easy transition as organizational structures vary widely within the industry. However, there are tremendous benefits in adopting fully integrated strategies for biopharma. This paper highlights the technical and operational challenges in current large molecule bioanalysis, value of collaborations across LBA and LC-MS platforms, and scientific expertise for fully integrated strategies

Plume dispersion from the Nelson and Hayes rivers into Hudson Bay using satellite remote sensing of CDOM and suspended sediment

International audienceChange in the dispersion pattern of Arctic river plumes due to climate change and hydroelectric regulation is challenging to monitor, calling for synoptic and continuous observation using satellite remote sensing. Algorithms for colored dissolved organic matter (CDOM) and total suspended solids (TSS) were applied to moderate resolution imaging spectroradiometer (MODIS) imagery to study Nelson and Hayes river plume dispersion into southwestern Hudson Bay, employing quantile regressions to capture dispersion variability along a freshwater-marine gradient. MODIS-derived CDOM and TSS quantile concentrations (Q 0.05-Q 0.95) decreased exponentially with distance from the Nelson River mouth. The Q 0.95 asymptote marked the offshore extent of the river plume and was used to determine the marine and river water fractions of surface water in southwestern Hudson Bay. At about 125 km from the Nelson River mouth, CDOM was reduced by 75% of its river mouth values. Owing to the significant co-variability between CDOM dilution and river discharge, a 0.25 river water fraction was estimated at this distance, which varied by ±35 km during flood and ebb flows. Anti-cyclonic winds transported the river plume along the 54 azimuth towards central Hudson Bay, while cyclonic winds propagated the plume eastward along the south shore. Particle settling in the coastal waters and resuspension events from mudflats and/or bank erosion caused non-significant relationships between TSS and river discharge. This non-conservative behavior renders TSS a less useful optical tracer of Nelson and Hayes river water in southwestern Hudson Bay. The novel quantile regression approach for defining boundaries of river water dilution in transitional waters may provide helpful information for coastal management on a spatial scale of tens to hundreds of kilometers, ranging from near real-time monitoring to seasonal and multi-year studies

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘Scientific’? : Part 1 – LCMS: small molecules, peptides and small molecule biomarkers

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3–7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event – a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid ligand binding assay (LBA)/LCMS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for biotherapeutics, biomarkers and immunogenicity assays using hybrid LBA/LCMS and regulatory agencies’ inputs. Part 1 (LCMS for small molecules, peptides and small molecule biomarkers) and Part 3 (LBA: immunogenicity, biomarkers and pharmacokinetic assays) are published in Volume 9 of Bioanalysis, issues 22 and 24 (2017), respectively