The establishment of appropriate specifications and release tests for drug substance and product is a crucial part of an analytical control strategy to support the manufacturing of pharmaceuticals. Antisense oligonucleotides (ASO) drugs are synthetic polymeric molecules that share many important attributes with pharmaceuticals. Without a formal regulatory guideline specifically written for oligonucleotides, a risk-based platform control strategy can be formed by following the general CMC principles and related guidance for both small molecule and biologics. The focus of this talk will be using a risk-based platform strategy to set the DS and DP specifications and select the appropriate release tests, while considerations for other related aspects 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