Course Description:
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.
This recording features
a presentation by Hong Jiang
Who should participate:
- 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
Access Duration:Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.