2nd Synthetic Therapeutic Peptides Workshop – Regulations, Standards and Quality

November 2, 2015 - November 3, 2015

Peptides represent one of the fastest growing segments in the pharmaceutical market. Being able to manufacture peptides that are consistent in makeup and quality is an important priority for manufacturers of this drug class. In 2013, USP established an Expert Panel on Therapeutic Peptides, tasked with tackling important issues related to peptide quality standards.  As the global pharmaceutical landscape continues to transform and as manufacturers explore different sources for viable product candidates, public quality standards will play a growing role in the manufacture of these drugs.

After a successful program in 2014 focused on manufacturing, analytical techniques for impurities and regulatory considerations, USP is bringing its Synthetic Therapeutic Peptides Workshop back again in 2015 for a more in-depth program which will examine raw material control strategies, the types of impurities and appropriateness of impurities methods, bioassay, peptides in vaccines, conjugated synthetic peptides and regulatory considerations.


Participant Goals

  • Better understand USP’s role in peptide space
  • Discuss control strategies for raw materials and impurities
  • Learn regulatory expectations for peptides, conjugated peptide and peptide vaccines
  • Achieve common regulatory understanding between USP, industry and FDA
  • Hear about changes/new info on monograph(s)/chapter(s) and provide feedback
  • Explore compendial science topics in order to inform the development of specific monograph(s)/chapter(s)


  • Raw materials
  • Impurities
  • Bioassay
  • Conjugated Peptides
  • Peptides in Vaccines
  • Regulatory Matters

Who Should Participate

  • Analytical chemists
  • QA/QC analysts
  • R&D scientists, managers
  • Manufacturing scientists, managers
  • Regulatory affairs specialists
  • Contract research organizations
  • Contract manufacturing organizations

Workshop Steering Committee

  • Donna Christner, Ph.D., FDA/CDER
  • Cory Evans, Ph.D., FDA/CVM
  • Michael DeFelippis, Ph.D., Eli Lilly
  • Elena Gubina, Ph.D., FDA/CBER
  • Marion King, Ph.D., Ipsen
  • Ved Srivastava, Ph.D., GSK
  • Anita Szajek, Ph.D., USP
  • Michael Verlander, Ph.D., Consultant