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.
The live version of this recording took place on March 3, 2021 and 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 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.