Knowledge Center | BioPharmaSpec

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.

On Demand Webinar: Structural Comparability Studies for Biosimilars

The information provided in this webinar will allow scientists to address the detailed requirements of Biosimilar comparative studies and gain an understanding of the detailed structural requirements entailed in assessing Biosimilarity.

On Demand Webinar: Characterizing Protein Impurities

This webinar will be informative to those concerned with biopharmaceutical manufacture, including product development, processing, formulation, stability and characterization.

On Demand Webinar: Understanding the Importance of Higher Order Protein Structure

Using the information presented in this webinar, you can plan comprehensive and regulatory compliant higher order structure characterization strategies to support formulation and process development, biosimilar comparability and stability studies.

On-Demand Webinar: Effective Biosimilar Comparability Studies

Anyone who is interested in the exciting field of biosimilar development, or who is working within a team with responsibilities for effective biosimilar characterization and comparability, will benefit strongly from watching this webinar.

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.

Technical Poster: The Importance of Understanding Higher Order Protein Structure

In addition to deducing the primary structure and any Post-Translational Modifications (PTMs) associated with your molecule, the regulators also require a full understanding of the higher order shape and structure.

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.

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.

Technical Poster: Structural and Physicochemical Characterization of Antibody Drug Conjugates (ADCs)

A BioPharmaSpec technical poster, with method descriptions and data relating to the characterization of an antibody-drug conjugate (ADC).

On-Demand Webinar: Mass Spectrometry Based Structural Characterization of Biopharmaceuticals

Join BioPharmaSpec CEO, Dr. Andrew J. Reason as he uses case studies from a monoclonal antibody, Antibody Drug Conjugate (ADC) and Insulin to explain the structural and physicochemical characterization requirements of ICH Q6B.

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.

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)

Publication: Glycoproteomics: Past, Present and Future

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

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)

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)

Publication: Disulfide Bridge Scrambling (Insulin)

Morris, H.R. et al: Protein Folding/Refolding Analysis by Mass Spectrometry: Scrambling of Disulphide Bridges in Insulin. Biochem. J. 268, 803-806 (1990)

Publication: Assignment of Disulfide Bridge Positions

Morris, H.R. & Pucci, P.: A New Method for Rapid Assignment of S-S Bridges in Proteins. Biochem. Biophys. Res. Commun. 126, 1122-1128 (1985)

Publication: Post-Translational Modifications

Robb, R.J. et al: Amino Acid Sequence and Post-translational Modification of Human Interleukin 2 PNAS 81, 6486-6490, (1984)

Publication: Peptide Characterization

Morris, H.R. et al: Isolation and Characterisation of Human Calcitonin Gene-Related Peptide (CGRP). Nature 308, 746-748 (1984)

Publication: Peptide Mapping

Morris, H.R., Panico, M. & Taylor, G.W.: Mapping of Recombinant DNA Protein Products. Biochem. Biophys. Res. Commun. 117, 299-305 (1983)

Publication: Peptide Mapping

Morris et al: Determination of the sequences of protein-derived peptides and peptide mixtures by mass spectrometry. Biochem. J. 125, 189-201 (1971)