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 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 MoreScientific 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 MoreScientific 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.
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