Whitepapers

Aug 24, 2016
Sponsor's Content
In this work, the separation of peptides obtained from a monoclonal antibody digest is demonstrated with a LC-UV-MS setup. This robust setup allows straightforward method transfer to UV-based QC applications.
Aug 23, 2016
Sponsor's Content
Intensified regulatory scrutiny of data and reporting has increased demand for authentication of documents used in bio/pharma development and manufacturing. Mollie Shields Uehling, CEO of SAFE-BioPharma an association working to provide high-assurance identity trust for cyber transactions, describes the role digital signatures can play in ensuring the integrity of documents used in drug development and manufacturing processes. The discussion includes applications for digital signatures in pharma research, development, and manufacturing; regulatory requirements for document authentication; and how digital signatures can improve document authentication and workflow within organizations and when collaborating with external partners.
Aug 23, 2016
Sponsor's Content
Properly characterizing biopharmaceutical products to better understand their physical and chemical properties is essential for regulatory approval. This article discusses some reasons and the regulatory impact of changing analytical technologies.
Aug 11, 2016
Sponsor's Content
By BioPharm International Editors
The quick capture and accurate titer analysis over a wide concentration range of monoclonal antibody is demonstrated using a TSKgel® Protein A-5PW, 20 μm analytical column.
Jul 25, 2016
Sponsor's Content
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
Sponsor's Content
This application note describes the analysis of residual solvents in pharmaceutical products in accordance with US Pharmacopeia (USP) method <467>.
Jul 15, 2016
Sponsor's Content
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
Sponsor's Content
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
Sponsor's Content
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
Sponsor's Content
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.
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