Course Description:
In the oligonucleotide therapeutics industry, the purity of active pharmaceutical ingredients (API) is paramount. Impurities in starting materials (SM) can significantly compromise API quality. This presentation proposes a comprehensive framework for assessing the risk posed by SM impurities. We introduce a methodology for systematic naming and labeling of SM impurities, facilitating easier identification and tracking. Central to this idea is the development of a scalable database that catalogs SM impurities, serving as a dynamic repository to support evaluation of future additions. The database will function as a risk assessment tool, guiding the implementation of targeted controls for SM impurity management. Recommendations drawn from this assessment aim to refine current best practices for SM impurity control. In a move toward transparency and collective progress, we will aim to make the database accessible to the public, fostering industry-wide engagement and feedback.
Who should participate:
- Regulatory scientists
- Analytical scientists
- Quality assurance analysts
- R&D scientists and managers
- Quality control analysts
- Contract research organizations
The live version of this recording took place during the USP Workshop on Therapeutic Peptides and Oligonucleotides: Regulations and Quality Standards on April 9-10, 2024 and features a presentation by David Butler.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.