Starting material specifications are a key element of the overall control strategy for synthetic oligonucleotides. In this presentation, we share our experience with setting smart specifications that on the one hand are meaningful controls for a specific oligonucleotide sequence and on the other hand enable us to use a platform approach to flexibly source starting materials to multiple oligonucleotide projects.

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