Publications

Publication: Mass Spectrometric Analysis of Process Related Impurities

Monitoring of residuals is of key importance in the control of process related impurities and is a requirement of the ICH Q6B guidelines.

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Publication: Understanding Biosimilars (Primary amino acid sequencing)

The primary amino acid sequence of a biosimilar must be identical to that of its associated innovator. This article describes these regulations and the sequencing techniques that can be used to meet the guidelines.

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Publication: Dissecting Structures (Higher Order Structure Determination)

This publication discusses the analytics that should be performed within a biophysical characterization, comparability or biosimilarity study in order to define higher order protein structure.

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Publication: Physicochemical Characterization of Insulin

Four well-established techniques: dynamic light scattering (DLS), circular dichroism (CD), nuclear magnetic resonance spectroscopy (NMR), and molecular modelling are combined to provide structural information about insulin.

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Publication: O-linked Carbohydrate Characterization

The characterization of O-linked glycosylation requires specific technical expertise and experience. In this paper, our scientists document glycosylation of the C-terminal threonine of the surface glycoprotein of 5 of 5 strains of HIV-1.

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Publication: Compare and Contrast (Biosimilar Comparability)

Although common excipients can often interfere with analytical data, use of appropriate techniques can prove that an active biological ingredient has not changed significantly and is suitable for side-by-side comparability studies.

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Publication: Sialic Acid Characterization

Pang, P.C. et al: Human Sperm Binding is Mediated by Sialyl-Lewis(X) Oligosaccharide on Zona Pellucida. Science 333, 1761-1764 (2011)

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Publication: Glycoproteomics: Past, Present and Future

Morris, H.R. et al: Glycoproteomics: Past, Present and Future. Int. J. Mass Spectrom. 259, 16-31 (2007)

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Publication: N-linked Glycosylation

Wacker, M. et al: N-Linked Protein Glycosylation in Campylobacter jejuni and its Functional Transfer into Escherichia coli. Science 298, 1790-1793 (2002)

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Publication: Presentation of QTOF-MS

Morris,H.R et al: High sensitivity collisionally-activated decomposition tandem mass spectrometry on a novel quadrupole/orthogonal-acceleration time-of-flight mass spectrometer. Rapid Communications in Mass Spectrometry 10, 889-896 (1996)

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