Whitepapers

Nov 30, 2016
Sponsored Content
Learn why the Thermo Scientific™ Vanquish™ Flex UHPLC system is used for efficient and reliable peptide mapping experiments.
Nov 30, 2016
Sponsored Content
Learn how the benefits of a fast analytical platform employing highly efficient chromatography in combination with fast and high-resolution quadrupole Thermo Scientific™ Orbitrap™ mass spectrometry technology as a tool for fast identification and quantification of sequence truncations, glycosylation and post-translational or artificial modification of recombinant monoclonal antibodies.
Nov 30, 2016
Sponsored Content
Peptide mapping is a common technique in the biopharmaceutical industry to characterize monoclonal antibodies (mAbs) for the determination of product identity and stability. Thermo Scientific™ SMART Digest™ kit was used to compare the classic in-solution protein digestion methods, focusing on protein sequence coverage and identified post-translational modifications, including deamidation, oxidation, and glycosylation.
Nov 30, 2016
Sponsored Content
Learn how to construct a simple time course experiment to identify the digestion endpoint for a given protein by monitoring degradation of the intact protein. The method is simple and uses LC-UV detection. Ribonuclease A, a small, heat stable protein, and mouse IgG, a large immunoglobulin, are used as test probes.
Nov 23, 2016
Sponsored Content
There have been several high profile reports related to the appearance of glass lamellae in parenteral pharmaceutical solutions. We discuss the best approach to identifying the problems through multiple analytical approaches.
Nov 19, 2016
Sponsored Content
Biotherapeutic proteins show promise for improving human health. Drug safety and efficacy are concerns for the manufacturer and regulatory agencies. Consequently, evaluation of anti-drug antibody (ADA) responses is important.
Nov 18, 2016
Sponsored Content
Designing an extractables and leachables project requires understanding the current trends in industry. There are various guidance documents including those listed in the USP as well as those from industry work groups. While all of the guidances provide information on performing studies none of these guidances are prescriptive. This whitepaper provides a brief assessment of these guidances and typical approaches utilized.
Nov 16, 2016
Sponsored Content
A recent report published by the Economist Intelligence Unit, The Changing Biopharma Risk Equation, revealed that biopharma executives were eager to explore new possibilities – from developing novel therapies to expanding in emerging markets. However, they were also concerned about risks, especially regulatory uncertainty. In this Q&A, Heike Michaelis shares her thoughts on the evolving regulatory landscape and what this means for the future of biopharma.
Nov 15, 2016
Sponsored Content
TOYOPEARL® AF-rProtein A HC-650F is capable of delivering high purity monoclonal antibodies with excellent recovery at loading levels approaching the resin capacity without any increase in aggregate levels.
Nov 08, 2016
Sponsored Content
The analysis of complex peptide mixtures and their identification is crucial for peptide mapping experiments. Increased peak capacity of the Thermo Scientific™ EASY-Spray™ C18, 75cm column offers enhanced quality of separation.
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