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Structural Comparison of Infliximab and a Biosimilar via Subunit Analysis Using the Waters Biopharmaceutical Platform with UNIFI

Waters
19 Feb 2015

This application note characterizes infliximab and a biosimilar candidate, produced in a different cell line, using Waters Biopharmaceutical Platform Solution. The objective is to screen multiple lots of both the innovator and biosimilar products at the subunit level to establish comparability at this higher level of structure. Lot-to-lot and batch-to-batch comparisons will show product variation, illustrating the range of quality attributes to be considered in a candidate biosimilar.

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ACQUITY UPLC H-Class PLUS Bio System

Waters

The ACQUITY UPLC H-Class PLUS Bio System delivers the benefits of UPLC's resolution, sensitivity, and throughput in a system purpose-built for the analysis of proteins, peptides, nucleic acids, and glycans.

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Biopharmaceutical Platform Solution with UNIFI

Waters

The Waters Biopharmaceutical Platform Solution with UNIFI® integrates robust UPLC®/MS characterization technology with the UNIFI Scientific Information System for applications in bioseparations, intact protein mass analysis, peptide mapping and released glycan analysis.This platform unites all aspects of biotherapeutic analyses and workflows, enabling organizations to apply high resolution analytics across the development process continuum. The platform captures complex mass spectrometry and chromatography data, and enables laboratories to comprehensively and routinely acquire, process, and share LC and MS characterization information throughout a biotherapeutic’s lifecycle. Results can be shared from discovery to development to GxP quality control.

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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.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.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.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.

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Structural Comparison of Infliximab and a Biosimilar via Subunit Analysis Using the Waters Biopharmaceutical Platform with UNIFI