Glycosylation Analysis for Biopharmaceuticals Workshop

August 25, 2015 - August 26, 2015

USP’s Workshop on Glycosylation Analysis for Biopharmaceuticals will be a forum for manufacturers, academia and regulators to discuss aspects of protein glycosylation and its impact on product quality. The workshop will focus on the role of glycosylation in therapeutic proteins, current analytical methods and next-generation technologies for glycosylation measurements, and assessing product comparability from the perspective of regulatory authorities and pharmacopeias.

Agenda

Poster Topics

  • New Japanese Pharmacopoeia General Test and General Information for Glycosylation Analysis of Glycoprotein
  • Advanced analytical technologies for N-Glycan profiling: Assessment of InstantABTM AssayMap® automation and GlycoworksTM Rapifluor-MSTM
  • Rapid Level-3 Characterization of Glycoprotein Therapeutics by CESI-MS
  • Click here for a full list poster presentations

Presentation Topics

  • How glycosylation affects bioassay, pharmacokinetics, safety, clearance and immunogenicity
  • Regulatory views on approval, comparability, legacy products and glycosylated biosimilars
  • Current analytical technologies for oligosaccharide and monosaccharide mixtures
  • Next-generation methods for analysis – such as O-link oligosaccharide analysis and glycoproteomics
  •  Emerging technologies – such as in vitro glycosylation and use of non-mammalian cells
  • Standards procedures, material reference standards and pharmacopeial views on glycosylation
  • Glycosylation control during post-approval changes—cell line considerations and cell culture processes

Objectives

  • Address “critical features” of glycosylation  and the relationship to pharmacological properties
  • Broaden  understanding of glycan analysis approaches
  • Examine commonly-used methods for glycosylation analysis, challenges and emerging technologies
  • Review latest developments for establishing quality standards related to glycosylated products
  • Highlight regulatory expectations and approaches

Who Should Participate

  • Analytical scientists
  • QA/QC specialists
  • R&D scientists and supervisors
  • Biopharmaceutical manufacturing scientists and supervisors
  • Regulatory affairs specialists
  • Contract research organizations
  • Contract manufacturing organizations

Planning Committee Members

  • Christopher Jones, Ph.D., Chair, USP Glycoproteins and Glycan Analysis Expert Panel; Chair, USP Vaccine Polysaccharide NMR Identity Testing Expert Panel; Member, USP General Chapters - Biological Analysis Expert Committee
  • Parastoo Azadi, Ph.D., Member, USP Glycoproteins and Glycan Analysis Expert Panel; Member, USP Monographs - Biologics and Biotechnology 1 Expert Committee
  • Edith Chang, Ph.D., USP Staff
  • John Cipollo, Ph.D., FDA Liaison, USP Vaccines for Human Use - Viral Vaccines Expert Panel
  • Michael DeFelippis, Ph. D., Chair, USP Therapeutic Peptides Expert Panel; Member, USP Monographs–Biologics and Biotechnology 1 Expert Committee; Member, USP Recombinant Therapeutic Monoclonal Antibodies Expert Panel; Member, USP Glycoproteins and Glycan Analysis Expert Panel
  • Trish Li, Ph.D., USP Staff
  • Earl Zablackis, Ph.D., Member, USP Monographs - Biologics and Biotechnology 2 Expert Committee; Member, USP Vaccine Polysaccharide NMR Identity Testing Expert Panel; Member, USP Vaccines for Human Use - Viral Vaccines Expert Panel
  • Rebecca Zangmeister, Ph.D, Member, USP Glycoproteins and Glycan Analysis Expert Panel

Registration Information

Regular Price Information

Online registration will be available through Wednesday, August 19. After that date, registration will be available on-site at the workshop.

Participant Type Registration Fee
Academic Participant $775        
Association Participant $775
Government Participant $175
Industry Participant $975
Poster Presenter (discount code provided upon abstract approval) $175
Student Participant $175

Group Discount Information

Participant Type Registration Fee
Academic Participant
3+ from the same institution
$625 per person
Association Participant
3+ from the same organization

$625 per person

Industry Participant
3+ from the same corporation
$825 per person

Location

USP–U.S.
12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8130
See map: Google Maps