Formulation and Quality – Biomolecular
2019 PharmSci 360
This panel discussion will include current opinions in biopharmaceutical industry regarding purpose, design, assumptions, and caveats in Forced Degradation studies. Best practices in temperature, pH and other stress conditions used in protein therapeutics will be in scope for discussion. Keeping in mind that the purpose of the FD studies (analytical method development/validation, formulation development, process development/characterization, long-term stability etc) will also dictate the FD study design. Recent examples from various laboratories can be cited to support the best practices.