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Sartorius Stedim Biotech Launches Chemistry Testing Services

Sartorius Group
4 May 2017
Weylan Kiam-Laine
Microbiologist

Product news

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced the launch of a full range of chemistry testing services. Offered by its subsidiary Sartorius Stedim BioOutsource, they characterize the physicochemical properties and structural attributes of therapeutic monoclonal antibodies (mAbs). The service platform methods have been developed to ensure rapid sample analysis and reporting for mAbs and biosimilars.

This comprehensive range of chemistry testing services complies with the well-established ICH Q6B scientific guidelines for pharmaceuticals for human use, and includes methods to characterize protein structure, carbohydrate profile, post-translational modifications and impurities utilizing UHPLC and LC/MS instruments. To provide these services, SSB has expanded laboratory space by 340 m2 at its facility in Glasgow, UK, and has appointed new scientists with extensive chemistry testing experience.

This chemistry testing offer complements the company’s existing range of off-the-shelf biological assays for biosimilar products, providing a complete solution from one contract partner. This allows structural and functional analyses to be conducted in parallel to deliver a comprehensive data package for regulatory submissions. As a result, the full-range of services enables SSB to even better support its customers in their drive to bring innovative biologic drugs to market.

“Rapid data-driven decisions at critical stages are crucial for the successful development of biosimilars. Our chemistry testing services enable biosimilar manufacturers to benefit from side-by-side biological and physicochemical analyses to gain the in-depth characterization data required,” explained Dr. Daniel Galbraith, Chief Scientific Officer at Sartorius Stedim BioOutsource. “Expanding our portfolio with these new services was a logical step following the successful launch of our Released N-Glycan assay in 2016,” he added.

To find out more about BioOutsource’s new range of chemistry testing services please visit: http://www.biooutsource.com/bioanalytical/physicochemical-and-structural-analyses/.

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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.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.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.UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.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.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.BiosimilarsBiosimilars are very similar versions of approved and authorized medicines. Clinically inactive components will have minor differences, but there are no significant differences between the biosimilar and the original product in terms of potency, purity and safety.Protein StructureProtein structure refers to the three-dimensional arrangement of amino acids in proteins, determining their function. Understanding protein structure is key in drug discovery, enzymology, and molecular biology. Explore protein structure analysis tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.CarbohydratesLC-MSLiquid Chromatography-Mass Spectrometry (LCMS) is a powerful analytical technique that combines the separation power of liquid chromatography with the detection capabilities of mass spectrometry. It is widely used for qualitative and quantitative analysis of complex mixtures in pharmaceuticals, proteomics, and environmental studies. Browse our peer-reviewed product directory to find the best LCMS systems, compare products, check reviews, and get pricing directly from manufacturers.

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