Whitepapers

Dec 08, 2017
Sponsored Content
By SCIEX
Routine characterization of biosimilars or batch comparison of manufactured biologic samples is critical to maintain quality for biotherapeutics throughout development and production. The large size and inherent heterogeneity of biologics make these drugs highly complex, requiring robust mass analysis techniques to ensure accuracy in detection of the protein backbone composition as well as the presence of post-translational modifications. This study analyzes trastuzumab biosimilar therapeutics obtained from two different manufacturing sources using subunit characterization to assess therapeutic mass and glycoform abundances. This work demonstrates the use of a fast, reproducible and robust method for biologic subunit analysis on the X500B QTOF system with streamlined and rapid batch processing and product comparison using the BioPharmaView™ software.
Nov 27, 2017
Sponsored Content
Hunky fully automates chemical denaturation experiments from start to finish, making it easy to access the unique stability and aggregation information ΔG provides. The four experimental applications span from low protein sample volume, quick screening experiments with C1/2 and Agg Path to robust stability quantification and aggregation measurements with ΔG and ΔGtrend. Hunky allows researchers to quantitate stability and avoid potential aggregation issues earlier than ever before.
Nov 23, 2017
Sponsored Content
The formation of aggregates is a common occurrence during mAb purification and can happen for several reasons. Generally, the formation of aggregates is shown to be product or process related. Here we show how on-column aggregate formation is dependent on the resin type and on the resin’s interactions with the mAb loaded. Among the various resins tested, a high-resolution cation exchanger, demonstrated the lowest proportion of on-column aggregate formation with two mAbs. On-column aggregate formation can therefore be minimized by proper resin screening and subsequent optimization of resin type used for process development.
Nov 20, 2017
Sponsored Content
Methods for capture of scFV and post-capture-washing condition with chaotropic agents are described. The post-capture-washing condition significantly improves HCP removal to increase scFV purity.
Nov 16, 2017
Sponsored Content
By SCIEX
LC-MS analysis has become a highly useful technique for the identification, characterization, and quantification of intact proteins as well as characterization of protein clippings and impurities. This technical note shows how the X500B QTOF system can be used to detect impurity levels in an intact monoclonal antibody analysis down to 0.001 ug/ul for glycosylated impurities and 0.0001 ug/ul for non-glycosylated impurities.
Oct 13, 2017
Sponsored Content
Presented is a three-column workflow developed for the production of a highly pure, histidine-tagged recombinant protein. A macroporous Ni2+ -charged affinity chromatography resin provides efficient capture of the target molecules with excellent selectivity, binding capacity, and recovery. This robust purification process provides the product quality, productivity, and economics demanded by today’s downstream manufacturing.
Oct 13, 2017
Sponsored Content
By SCIEX
Peptide-based mass spectrometry methods are generally preferred for the site-specific quantitation of oxidation levels of biotherapeutics. In this study, differential levels of oxidation were induced by incubating a monoclonal antibody standard with increasing concentrations of oxidizing agent (H2O2) prior to digestion. The high-quality data obtained from the X500B instrument, in combination with BioPharmaView™ software, allowed accurate and automated quantitation of sites susceptible to oxidation, making it a robust tool for routine sequence coverage analysis, as well as quantitation of critical quality attributes.
Sep 25, 2017
Sponsored Content
Uncle is an all-in-one stability platform that enables 11 different applications. In this application note, we describe NISTmAb data collected on the Uncle platform that demonstrates the versatility, reliability and ease-of-use of the instrument.
Sep 19, 2017
Sponsored Content
TOYOPEARL NH2-750F resin is a salt tolerant AEX resin ideal for the removal of endotoxins in mAb. It works in the presence of 150 mmol/L NaCl and a relatively low pH.
Sep 15, 2017
Sponsored Content
By SCIEX
The SCIEX X500B QTOF System with BioPharmaView™ Software enables routine characterization of biologics through all stages of discovery and development. The following study demonstrates these capabilities for the characterization of different manufactured lots of the biotherapeutic Trastuzumab. With streamlined workflows, SCIEX solutions simplify intact protein analysis, sub-unit analysis, peptide mapping, identification of modifications, and comparability analyses.
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