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.

Subject area:
Biologics

Objectives (If applicable):
na

Target Audience (If applicable):
– Regulatory scientists
– Analytical scientists
– Quality assurance analysts
– R&D scientists and managers
– Quality control analysts
– Contract research organizations