Presenter: Gemma Lo, Senior Product Manager, Avantor


Regulatory guidelines (ICH Q6B) state that a detailed characterization of all therapeutic biomolecules is carried out prior to any new product launch. It is important to confirm primary structure and identify any post translational modifications (PTMs) which have occurred during manufacturing processes. When considering Biosimilars a comparison should be made with the Originator therapeutic. Chromatography is a well-established technique for the analysis of small molecule therapeutics, their related substances and stability and is useful for both quantitation and quality purposes. In this webinar we discuss how you can draw from experience with small molecule method development to optimize biomolecule methodologies. We also discuss how ion pair reagents can be added to the mobile phase to enhance the interaction of more polar biomolecules like oligonucleotides, and lead to excellent separations even to the n+/-1 level. Whether you are working with peptides or proteins, this webinar aims to provide ideas on how to approach their analysis using well understood and recognized modes of chromatography.

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