USP Workshop on Therapeutic Peptides and Oligonucleotides

peptides workshop

Register Now Agenda

Overview

Therapeutic peptides and oligonucleotides are rapidly growing product classes; however, novel modifications and formulations present new challenges for the products. Therefore, additional best practices and guidance are critically needed to expedite quality products coming to the global market.

USP will continue to support therapeutic peptides and oligonucleotides by gathering experts from the analytical, process development, and regulatory communities to share best practices and success stories.

The presentations and Panel discussions with experts across the globe will provide opportunities for attendees to ask questions and dig deeper into the presented content.

Key session topics

(See Call for Abstracts for additional details)

  • Drug formulation and design
  • Manufacturing technologies
  • Analytical development, characterization, and validation
  • Control strategies
  • Regulatory aspects
  • Raw materials for drug substance

Workshop Steering Committee

  • Michael De Felippis, Ph.D., Chair, Distinguished Research Fellow, Eli Lilly & Co.
  • Marc Lemaître, Ph.D., Principal, ML Consult LLC
  • Antonio Ricci, Ph.D., VP Innovation & Development API, Fresenius Kabi
  • Gerhard Haas, Ph.D., VP of Quality, Bachem
  • Julie Zhang, Ph.D., Principal Scientist, USP
  • Bruno De Carvalho, Ph.D., Stakeholder Engagement Manager, USP

Who should participate?

  • Scientists developing peptides and oligonucleotides
  • QA/QC analysts
  • Manufacturing and process development scientists, managers
  • Quality and regulatory staff supporting supplier evaluation, agreements and audits
  • Contract research organizations
  • Contract manufacturing organizations
  • Raw material vendors

Questions? Please contact Bruno.decarvalho@usp.org