Therapeutic Peptides and Oligonucleotides: Regulations, Standards and Quality
USP Workshop
Monday, November 4th – Tuesday, November 5th

USP Headquarters
Rockville, Maryland

The U.S. Pharmacopoeia (USP) Therapeutic Peptides and Oligonucleotides: Regulations, Standards and Quality workshop is a 2-day event taking place November 4-5 in Rockville, Maryland. EpiVax’s Dr. De Groot has been invited to speak on November 5. Her presentation is scheduled for 9:55AM.

Dr. De Groot’s presentation, “New Dogs/Old Tricks: Methods for Assessing the Immunogenicity of Peptide Drugs and Their Impurities,” will cover the new draft guidance for generic peptide drugs, highlighting FDA concern about the potential for peptide drugs and their impurities. It will also focus on EpiVax’s peptide abbreviated new drug application (PANDA) program, a 3-step approach to immunogenicity risk assessment for peptide drugs and their impurities.

READ THE SUBMITTED ABSTRACT HERE!

ABOUT THIS WORKSHOP:

This workshop continues USP’s mission to inform public standard setting for therapeutic peptides and peptide vaccines while introducing similar considerations for therapeutic oligonucleotides. This workshop will focus on the following topics:

  • Challenges in measurement and specification setting, particularly for impurities
  • Innovative analytical and manufacturing technologies
  • Immunogenicity
  • Bioassays for complex products
  • Peptide vaccines: analytical and regulatory strategies
  • Oligonucleotide products
  • Peptide and oligonucleotide standards
  • Regulatory expectations for peptides and oligonucleotides
  • Raw materials
  • Manufacturing and control strategies

To learn more about the workshop and/or to register, please visit USP’s official event page.