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Scientific Article: Use of Maurice CE-SDS in ICH Q6B based Biosimilar Comparability Exercises
The studies presented in this article demonstrate the utility of Maurice platforms in biosimilar development through the characterization of certain monoclonal antibodies, heavily glycosylated species, and PEGylated species.
Read MoreWebinar: Using an Automated CE-SDS Platform in Efficient Biosimilar Comparability Studies
This webinar provides expert insight from Dr. Richard L. Easton, Technical Director of Structural Analysis at BioPharmaSpec into using an Automated CE-SDS Platform in Efficient Biosimilar Comparability Studies.
Read MoreScientific Article: Dealing with the challenges of post translational modification (PTMs)
Post translational modifications (PTMs) are changes that occur in a protein following its production. The technique of peptide mapping provides significant and key information on PTMs.
Read MoreScientific Article: Dealing with The Challenges of Sequence Variants
This article, by BioPharmaSpec's Technical Director, Richard L. Easton, looks at how sequence variants occur, why it is important to assess for them and the best analytical techniques to characterize potential sequence variants in biopharmaceuticals.
Read MoreOn Demand Webinar: Host Cell Protein Analysis by Mass Spectrometry
This webinar will describe the use of LC-MS based analytical techniques as an orthogonal approach to HCP-ELISA and will benefit all scientists involved in drug development, manufacture, downstream processing and quality control.
WATCH NOWPodcast: Quality in Early Stage/ Protein Characterization Studies
BioPharmaSpec’s Director of Quality, Daniel Binet, discusses the importance of quality in preclinical structural characterization studies. How can we ensure these non-GxP methods are fit for purpose and have confidence in the data generated?
LISTEN NOWPodcast: Impurity Analysis by Quantitative Mass Spectrometry
BioPharmaSpec's Technical Director, Dr. Richard L. Easton talks to Steven Broome, Senior Mass Spectrometrist, about using mass spectrometry for a qualitative and quantitative assessment of residual process and product related impurities.
LISTEN NOWScientific Article: 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.
Read MorePodcast: The Structure Function Relationship
During this podcast, you will join a teleconference with technical experts from both the structural and the functional sides of protein characterization to discuss the importance of correlating structure and function.
LISTEN NOWPublication: 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.
Read MoreOn 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.
WATCH NOWOn Demand Webinar: Characterizing Protein Impurities
This webinar will be informative to those concerned with biopharmaceutical manufacture, including product development, processing, formulation, stability and characterization.
WATCH NOWOn 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.
WATCH NOWOn-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.
WATCH NOWPublication: 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.
Read MoreTechnical 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.
Read MorePublication: 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.
Read MorePublication: 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.
Read MoreTechnical 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).
Read MoreOn-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.
WATCH NOWScientific Article: 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.
Read MorePublication: 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)
Read MorePublication: Glycoproteomics: Past, Present and Future
Morris, H.R. et al: Glycoproteomics: Past, Present and Future. Int. J. Mass Spectrom. 259, 16-31 (2007)
Read MorePublication: 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)
Read MorePublication: 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)
Read MorePublication: 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)
Read MorePublication: 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)
Read MorePublication: Post-Translational Modifications
Robb, R.J. et al: Amino Acid Sequence and Post-translational Modification of Human Interleukin 2 PNAS 81, 6486-6490, (1984)
Read MorePublication: Peptide Characterization
Morris, H.R. et al: Isolation and Characterisation of Human Calcitonin Gene-Related Peptide (CGRP). Nature 308, 746-748 (1984)
Read MorePublication: Peptide Mapping
Morris, H.R., Panico, M. & Taylor, G.W.: Mapping of Recombinant DNA Protein Products. Biochem. Biophys. Res. Commun. 117, 299-305 (1983)
Read MorePublication: 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)
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