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Live Webinar: <1084> Glycoprotein Glycan Analysis

Course Information:

Course Description:

Protein Glycosylation can be a key factor defining the in vivo biological activities of biopharmaceutical products. Because it is defined by the host cell line and modulated by growth conditions, it can be variable between product batches, between manufacturing plants and between nominally identical products produced by different manufacturers. Analysis of Glycosylation is a requirement during product development, in comparability studies and often in lot release. Since glycosylation is protein, cell line and manufacturer dependent, establishment of suitable reference standards for individual products is inappropriate. USP has chosen a strategy which ensures the optimal performance of the analytical method, through the use of ‘horizontal’ or procedural standards. These complement chapters which have, or are being, drafted. Chapter <1084> is an overview chapter, explaining the different options for characterising protein glycosylation, whilst two other chapters, currently in development, dealt specifically with analysis of sialic acid and other monosaccharide components, and intact cleaved glycan chains (Chapters <210> and <212> respectively). This webinar will highlight the strategy that USP is taking to include glycan analysis, explaining the content of the chapters and how these will be linked to suitable reference standards. There will be a Q&A session after the presentation.

Who Should Attend:

Analytical chemists involved in development and implementation of characterization and QC procedures for biopharmaceuticals; Regulatory scientists involved in planning QC approaches for biopharmaceuticals


1 hour

Learning Objectives and Course Outline:

Learning Objectives
  • To explain the approach that USP is taking towards glycoprotein glycan analysis, based on a combination of qualitative and quantitative standards
  • To explain the content of the three general chapters: <1084>; <210> and <212> that are being developed
  • To describe the reference standards that are being developed

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