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GEN Presents An Educational And Informative Webinar

Analysis of N-Glycan Released from Biopharmaceutical Glycoproteins Using HPAE-PAD

  • Broadcast Date: Tuesday, July 30, 2013
  • Time: 8:00 a.m. PST, 11:00 a.m. EST, 15:00 GMT, 16:00 BST, 17:00 CEDT

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Unlike conventional drugs, recombinant protein drugs are highly complex molecules with remarkable heterogeneity. Protein glycosylation affects the safety, efficacy, and serum half-life of these biopharmaceuticals. Therefore analysis of the glycan pattern is an important issue for characterization and quality control in the biopharmaceutical industry. When making these products, the manufacturers have to deliver a consistent product quality to guarantee a reproducible clinical performance.

Underivatized N-glycans have no light-absorbing properties. They have to be derivatized with a chromaphore (2-aminobenzamide, 2-AB) in order to be analyzed by HPLC and UV detection. High performance anion exchange chromatography with pulsed amperometric detection (HPAE-PAD) does not require modification of the glycans before analysis. This technique is optimized to determine monosaccharides, sialic acids, oligosaccharides and other carbohydrate components of glycoproteins.

This webinar will discuss how HPAE-PAD performs accurate and consistent mapping of N-glycans released from biopharmaceuticals such as EPO, FSH and Erbitux.

Key Learning Objectives:

  • Principles of HPAE-PAD and how it can be a powerful tool in carbohydrate analysis
  • Anion-exchange columns optimized for carbohydrate separations
  • GMP validated HPAE-PAD methods according to ICH/EU guidelines for release testing of human biopharmaceuticals
  • HPAE-PAD mapping of native N-glycans released from recombinant biopharmaceuticals e.g. EPO, FSH and Erbitux.

Who Should Attend:

  • Analytical chemists who want additional understanding of HPAE-PAD and carbohydrate analysis.
  • Product Development scientists who need to become knowledgeable about methods for studying and identifying carbohydrates in biopharmaceuticals.
  • Quality Control and Regulatory Affairs professionals in the biotechnology industry

A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.

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Panelists

  • Petr Jandik, Ph.D.,
  • Principal Scientist
  • Research and Development
  • Thermo Fisher Scientific
  • Sebastian Kandzia,
  • Head of Oligosaccharide Analytics
  • GlycoThera

Moderator

  • John Sterling
  • Editor in Chief
  • Genetic Engineering & Biotechnology News

Produced with support from