Whitepapers

Jul 25, 2016
BioPharm International
By BioPharm International Editors
Top-down protein fragmentation generates diverse fragment ion types and a multitude of charge states with overlapping spectral patterns. This data complexity complicates the process of producing primary structural assignments – usually through manual annotation – leading to the necessary development of software tools that automatically deconvolute raw spectral MS-MS data, annotate fragmentation patterns to protein sequences, and generate reports. These challenges have impeded broader usage of top-down protein analysis for routine biotherapeutic mAb development. This application note demonstrates the acquisition of protein top-down analysis data by collision induced dissociation (CID) or electron transfer dissociation (ETD) MS-MS fragmentation from the SYNAPT® G2-Si HDMS Mass Spectrometer. The data from these analyses was imported into UNIFI for processing, review, and report generation. This automated data processing workflow enabled efficient sequence verification, along with identification of modifications for a mAb and its subunits.
Jul 21, 2016
BioPharm International
This application note describes the analysis of residual solvents in pharmaceutical products in accordance with US Pharmacopeia (USP) method <467>.
Jul 15, 2016
BioPharm International
Given the ability of Multi-Column Continuous Chromatography technology to remove upwards of 95% of cell culture related impurities in a single step, a high performing protein A resin is essential in order to reduce subsequent process steps to remove impurities such as host cell proteins. The use of protein A in conjunction with an effective second step, in this case hydroxyapatite, will enable chromatographers to generate large quantities of antibody using much less resin than in a typical single column approach.
Jul 12, 2016
BioPharm International
This paper reviews the qualification of cell-based assays for functional comparability analysis that provide an attractive alternative to more expensive and time-consuming assays.
Jun 30, 2016
BioPharm International
This Application Note demonstrates the analysis of mAbs with the Agilent 1290 Infinity II 2D-LC solution using protein A titer analysis combined with ion exchange chromatography for charge variant profiling.
Jun 24, 2016
BioPharm International
This Application Note shows a combination of aggregate analysis with size exclusion chromatography in the first dimension, followed by ion exchange chromatography for charge variant profiling in the second dimension. Heart-cutting 2D-LC enables online transfer of peaks from the first dimension to the second dimension, allowing highly precise aggregate analysis and charge variant profiling.
Jun 20, 2016
BioPharm International
This application note describes a simple and sensitive SEC method for determining the purity of PEG Granulocyte Colony Stimulating Factor (PEG GCSF.)
Jun 17, 2016
BioPharm International
This app note demonstrates a new rapid and streamlined N-glycan sample preparation that affords unprecedented sensitivity for fluorescence and MS-based HILIC methods.
Jun 15, 2016
BioPharm International
This technical note illustrates the ability to characterize antibody aggregates by covalently stabilizing them with cross-linking reagents, fractionating the cross-linked aggregates by SEC and finally analyzing the fractions using high mass MALDI-TOF mass spectrometry.
May 27, 2016
BioPharm International
Several advances in scale-down models have accelerated biopharmaceutical process development. They are increasingly adopted by the biopharmaceutical industry and serve as an indispensable tool for process development, characterization, optimization, and validation.
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