Gene therapies offer tremendous promise to address human disease but their complexity and diversity present unique challenges to those seeking to standardize materials and methods. USP is engaging with stakeholders to identify and develop documentary and physical standards to support gene therapy. This presentation will provide an overview of existing USP documentary and physical standards as well as an update on standards under development.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
• QA/QC analysts
• R&D scientists, managers
• Team members in CMC development projects
• Manufacturing and process development scientists, managers
• Regulatory affairs specialists
• Contract research organizations
• Contract manufacturing organizations