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Abstract

Metabolomics is the comprehensive study of small-molecule metabolites. Obtaining a wide coverage of the metabolome is challenging because of the broad range of physicochemical properties of the small molecules. To study the compounds of interest spectroscopic (NMR), spectrometric (MS) and separation techniques (LC, GC, supercritical fluid chromatography, CE) are used. The choice for a given […]

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HIGHLIGHTS

Although, LC–MS is one of the most sensitive and selective analytical techniques, it often suffers from matrix effects, especially when using ESI for analyzing extracts of complicated matrices [1–3]. Matrix effects are often caused by the alteration of ionization efficiency of target analytes in the presence of co-eluting compounds in the same matrix. Matrix effects

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Abstract

Current fundamental investigations of human biology and the development of therapeutic drugs commonly rely on 2D monolayer cell culture systems. However, 2D cell culture systems do not accurately recapitulate the structure, function or physiology of living tissues, nor the highly complex and dynamic 3D environments in vivo. Microfluidic technology can provide microscale complex structures and

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Abstract

The metabolic investigation of the human population is becoming increasingly important in the study of health and disease. The phenotypic variation can be investigated through the application of metabolomics; to provide a statistically robust investigation, the study of hundreds to thousands of individuals is required. In untargeted and MS-focused metabolomic studies this once provided significant

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Abstract

The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that

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Abstract

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in

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Abstract

Over the past 10 years, there has been a remarkable increase in the use of LC–MS for the quantitative determination of proteins, and this technique can now be considered an established bioanalytical platform for the quantification of macromolecular drugs and biomarkers, next to the traditional ligand-binding assays. Many researchers have contributed to the field and

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Abstract

Gene therapy, cell therapy and vaccine research have led to an increased use of qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the development and validation of qPCR and ddPCR assays. Currently, however, there is limited regulatory guidance for the use of qPCR and a complete lack of any regulatory guidelines for the use of

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HIGHLIGHTS

Although, LC–MS is one of the most sensitive and selective analytical techniques, it often suffers from matrix effects, especially when using ESI for analyzing extracts of complicated matrices [1–3]. Matrix effects are often caused by the alteration of ionization efficiency of target analytes in the presence of co-eluting compounds in the same matrix. Matrix effects

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Abstract

Keywords: bispecific biotherapeutics,clinical antidrug antibody characterization,multidomain,biotherapeutics,pre-existing antidrug antibody,treatment-emergent antidrug antibody Antibody engineering has dramatically evolved in recent years, resulting in current conventional antibody therapeutics having fewer immune-related adverse effects observed in the clinic. However, the advanced antibody engineering technologies have also created a great variety of novel antibody-based therapeutics with bispecific and multispecific domains entering

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