Oligonucleotide drugs are a special class of therapeutics that are not explicitly cover by the regulatory and CMC guidances that cover low molecular weight therapeutics. This presentation will discuss some of the regulatory challenges for synthetic oligonucleotides seen in INDs and NDAs. In particular, the CMC issues for Manufacturing, Characterization and Control of Drug Substance 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