Live eLearning - PDA 613.1 Biopharmaceutical Impurities: Impact on Macromolecular Stability and Patient Safety

This training course is designed to instruct the attendees in:

• The sources and identification of impurities in Biopharmaceuticals
• The regulatory guidelines for monitoring impurities in the Biopharmaceutical Industry
• Potential impacts of impurities on patient safety
• Potential impacts of impurities on the active pharmaceutical ingredient (primarily large molecules/proteins)
• Methods for monitoring the effect of impurities on macromolecular stability

1. Communicate the sources and chemical identification of the most common impurities found in biopharmaceutical products
2. Define what regulatory guidelines are in place that govern the investigation and identification of biopharmaceutical impurities
3. Define the regulatory impact of adverse patient safety events, and guidelines for understanding and ensuring patient safety as it relates to impurities present in the packaged drug product
4. Review the chemical and thermodynamic nature of biological macromolecules
5. Demonstrate how to set up experiments to determine the impact of impurities on the stability of the protein molecule