Scientific Articles

Scientific 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.

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Scientific 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.

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Scientific 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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