Comparison of nanoDSF and µDSC for Thermal Stability Assessment during Biopharmaceutical Formulation Development

15 Feb 2017

In this study, two methods for the detection of thermal unfolding transition temperatures of a therapeutic monoclonal antibody are compared: nanoDSF, which analyzes changes in the fluorescence emission properties of proteins, and differential scanning calorimetry (µDSC), which detects changes in the heat capacity of a protein solution upon unfolding. The assessment of thermal stability parameters of biologics is an integral part of formulation development in biopharmaceutical research, which demands rapid and precise methods to quickly screen large sets of conditions in an easy and straightforward manner. Both nanoDSF and µDSC provided precise and consistent data. However, nanoDSF overcame several limitations by µDSC, such as low throughput and high sample consumption, and thus represents the ideal technology for rapid and precise thermal stability screening in biopharmaceutical development.

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Combinatorial ChemistryCombinatorial chemistry, also known as combichem, is a technique used in drug discovery to create libraries of structurally related compounds. A library is generated by synthesis with a chemical reactor system or by computer-based modeling of compound combinations. When undertaking combinatorial chemistry consider reagents, buffers, resins and standards.ProteomicsProteomics is the systemic bioinformatics study of proteins and amino acids, including their structure, size, function and identification. Tools used in proteomics include chromatography, blotting and gels, protein arrays, mass spectrometry and ELISA and associated analysis software. Analyzers and proteomic systems should be sensitive, high resolution, fast and may be automated for high-throughput.Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Development SoftwareComputational techniques used in both the chemistry and biology aspects of drug development, for data acquisition, data analysis, processing and storage. Software is used for analysis of ADME results, toxicology, clinical trials and regulatory processes. Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.Monoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.Temperature ControlTemperature controlled processes are experiments carried out using ovens, furnaces, incubators, hotplates, refrigeration and freezers.Thermal ProcessesFluorescence Based AssayFluorescence based assays are widely used in life science research and high-throughput screening to measure a broad range of cellular activities.Protein BiologyThe analysis of protein expression, identity and function is vital for many areas of life science research and drug discovery. Some of the most commonly used techniques in protein analysis include Western blotting, electrophoresis and mass spectrometry.High ThroughputHigh throughput experiments allow the simultaneous processing of several samples. This parallelization reduces the cost per experiment and increases reproducibility and output volume of data.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.FormulationFormulation is the process of combining active pharmaceutical ingredients with excipients to produce a drug which is both stable and active.
Comparison of nanoDSF and µDSC for Thermal Stability Assessment during Biopharmaceutical Formulation Development