This presentation will provide an overview what can oligonucleotide and peptide developers learn from each other in their regulatory experiences, regardless of whether they are working on an oligonucleotide or a peptide. Common CMC issues that face both groups will be highlighted and experiences from recent regulatory submissions will be discussed.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
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