ResourceSpectroscopy

Enhancing Efficiency and Economics in Process Development and Manufacturing of Biotherapeutics

11 Sept 2017

Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development and manufacturing of biotherapeutics. To characterize the functional activity of proteins during biotherapeutic development, label-free biosensor based binding assays are increasingly being utilized. This application note describes how biopharmaceutical companies have adopted ForteBio's Octet system for protein quantitation in the areas of process development and quality control.

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MicroplatesMicroplates are multi-well plates used to increase the throughput of biological investigations. The number of wells microplates contain can range from 6 to 3243 wells, with the 96-well format being the most commonly used. Microplates can come tailored for a range of applications including cell culture, PCR, filtration, storage, non-binding surface, protein crystallization, as well as pre-coated, deep well and normal Standard microplates. Additionally, options for microplate colors include clear , black, white or black with clear bottom and white with clear bottom for absorbance microplate reader applications. Find the best microplates for your lab in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.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.Protein PurificationProtein purification is a vital step in drug discovery, therapeutics, biotech and life science research. The purification process typically involves subcellular or membrane protein extraction with cell lysis kits, separation of proteins from cell debris by filtration or spin columns, and the isolation of proteins of interest from other proteins and impurities with affinity purification (including fusion protein tags and antibody binding proteins A, G and L), immunoprecipitation or chromatographic methods, such as ion exchange, size exclusion and immobilized metal affinity chromatography. All purification methods come in multiple formats for your laboratory needs, including agarose or magnetic beads, resins, columns and filter plates. Find the best protein purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.InterferometryInterferometry is an investigative technique used to analyze the pattern of interference created during the superposition of 2 or more waves. An interferometer is used to produce 2 or more overlapping waves. The interferometer is comprised of 2 or more telescopes, a detector and a correlator. The interferometer detector may utilize homodyne or heterodyne detection of the interference pattern.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.Plate ProcessingAutomated plate processing is used in microplate technologies for high-throughput, speed and efficiency. Plate processing systems include microplate handlers for moving plates, heat sealers, stackers and carousels for storage, retrieval and delivery, microplate washers and piercers. Useful features of plate processors include walk-away automation, compatibility and easy integration with microplate systems.Protein QuantificationThe detection and quantification of proteins in a sample is vital across life sciences, pharmaceutical research and clinical diagnostics, and a variety of equipment is available to scientists to simplify the workflow. Proteins of interest can be easily labeled and detected on light-based detection instruments. Immunoassay kits allow you to identify a specific protein of interest and protein detection beads or antibody microarrays allow you to identify multiple specific proteins at once. Protein interactions and enzyme activity can also be monitored with protein-protein interaction assays. Additionally, the biophysical characterization of proteins is made easy with biokinetic analyzers. Find the best protein detection and quantification products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. 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.Sample ConcentrationSample concentration involves the removal of solvents from samples using technologies such as centrifugal evaporation, lyophilization and rotary evaporation.Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.