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Over the developmental lifetime of a therapeutic protein, the immunogenicity assay validation history can become substantial, frustrating review of clinical immunogenicity within the biologics license application. In our experience, this can lead to questions by regulators, resulting in numerous information requests during the review process. To address this, we propose a new document, the method […]

In the past few decades, dried blood matrix biosampling has witnessed a marvelous interest among the researcher due to its user-friendly operation during blood sampling in preclinical and clinical applications. It also complies with the basic 3Rs (reduce, reuse and recycle) philosophy. Because of comparative simplicity, a huge number of researchers are paying attention to

Discovery proteomics research has made significant progress in the past several years; however, the number of protein biomarkers deployed in clinical practice remains rather limited. There are several scientific and procedural gaps between discovery proteomics research and clinical implementation, which have contributed to poor biomarker validity and few clinical applications. The complexity and low throughput

Aim/Materials & methods: Guidelines like United States Pharmacopeia 1032 [1] and pharm.Eur. [2] acknowledge that cell-based bioassays are complex methods and thus prone to outliers. However, investigations into root causes of outliers are often inconclusive. We have established a procedure (including quality control and documentation) implemented in a freely available software application which includes not

Aim: There is little information in the literature regarding assays for measuring CDH17 in tissues. Numerous studies indicate overexpression of CDH17 in a variety of diseases including hepatocellular carcinoma, colorectal and gastric cancer. Here we present an immunoaffinity enrichment LC–MS/MS approach for analysis of CDH17 in human tissues, plasma and serum as well as preclinical

In 2012, the European Bioanalysis Forum published a recommendation on biomarker method development and the bioanalysis of biomarkers in support of drug development. Since then, there has been significant discussion on how to bring the topic of context of use of biomarker assays to the forefront so that the purpose of the assay, the use

Immunogenicity is recognized as a possible clinical risk due to the development of anti drug antibodies (ADAs) that can adversely impact drug safety and efficacy. Although robust assays are currently used to assess the ADA, there is a debate on how best to generate the most appropriate immunogenicity data. There are several factors that can

Background: S1PR1, a G protein-coupled receptor (GPCR) protein, is a therapeutic target for treatment of autoimmune diseases. As a potential biomarker for drug effect and patient stratification, it is of great significance to measure it in biological samples. However, due to the hydrophobic nature of S1PR1 and the difficulties in extraction and solubilization, as well

Background: Vancomycin is a commonly used antibiotic, which requires therapeutic drug monitoring to ensure optimal treatment. Microsampling assays are attractive tools for pediatric clinical research and therapeutic drug monitoring. Results: A LC–MS/MS method for the quantification of vancomycin in human whole blood employing volumetric absorptive microsampling (VAMS®) devices (20 μl) was developed and validated. Vancomycin

Aim: Drug interference poses great analytical challenges for cell-based neutralizing antidrug antibodies (NAb) assay. The work aimed to improve assay drug tolerance through biotin-drug extraction with acid dissociation method optimization and developing new approach. Results: The NAb extraction with biotin-drug extraction with acid dissociation approach has been optimized by reducing biotinylated drug leaching and improving