The number and potency of highly potent drug substances are increasing. Formulators working with highly potent active pharmaceutical ingredients (APIs) are challenged to ensure the safety of personnel during development and manufacturing and healthcare workers and patients when using the final drug products. That means addressing potential issues with the homogeneity of the formulation, drug content analysis, and proper handling. In the manufacture of highly potent compounds, special consideration needs to be given to the technical and organizational controls that will ensure operator safety and minimize cross-contamination risks. Understanding product classification and the heightened complexity of transfer and manufacturing is critical to the success of bringing these highly potent medicines to patients in need.
Pfizer CentreOne's oral solids experts discuss key considerations for highly potent oral solids, focusing on three key challenges faced during development and manufacture. Discover more about the challenges and considerations when developing and manufacturing your highly potent oral solid.
Key learning objectives:
- Understand the importance of containment strategies during manufacturing
- Learn about key regulations relevant to highly potent oral solids
- Explore the formulation challenges relating to highly potent oral solids