Therapeutic Peptides and Oligonucleotides: Regulations, Standards and Quality

Register Agenda Speakers, Biographies & Abstracts


This workshop continues USP’s efforts to inform public standard setting for therapeutic peptides and peptide vaccines while introducing similar considerations for therapeutic oligonucleotides.

Key Session 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

Why Attend?

  • To better understand USP’s standards for peptide and oligonucleotide products
  • To learn about new peptide and oligonucleotide targets and novel advances in manufacturing, purification technologies, analytical methods strategies and bioassay
  • To learn regulatory expectations for peptides, conjugated peptides, peptide vaccines and oligonucleotide therapies
  • To achieve common regulatory understanding between USP, industry, and Regulatory Agencies
  • To network with other manufacturers, scientists, and regulators in this area
  • To provide feedback about proposed changes/new information on peptide monograph(s) and chapter(s)
  • To explore compendial science topics in order to inform the development of specific monograph(s) and chapter(s)

Who Should Participate?

  • Analytical chemists
  • QA/QC analysts
  • R&D scientists, managers
  • Team members in CMC development projects
  • Manufacturing scientists, managers
  • Regulatory affairs specialists
  • Contract research organizations
  • Contract manufacturing organizations

Pricing Information

Participant type Regular fee per person (1-2 individuals from the same organization) Early bird discount (register by September 28, 2019) Multi-registrant pricing (3 or more individuals from the same organization; all must register at the same time to receive discount)
Academia $650 $600 $585
Association $650 $600 $585
Government $200 N/A N/A
Industry $1000 $850 $800
Student $200 N/A N/A
Virtual* $395 N/A N/A

*Connection information for Virtual Participants will be sent three (3) business days prior to event.

Advance Registration Deadline

Advance Registration will be available through Thursday, October 31, 2019; 12 noon EST. On-site registration will be available starting at 8 am, Monday, November 4, 2019 at the USP Meetings Center.

Cancellation and Substitution Policy

Cancellation must be received on or before October 5, 2019 via email to

Refunds will not be issued for cancellations received after this date. There is a $50 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to

Invitation Letters for Visas

USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.

Registration Questions

Please contact or +1 301-816-8130.

Local Area Information

Visit our Travel & Transportation page for information on lodging, airports, and local transportation in and around USP’s Rockville, Maryland, campus.

Rockville, MD, USA