Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

No drug substance or drug product is acceptable without a satisfactory stability profile. Yet, protein drug substances and drug products offer unique challenges when it comes to stability. From storage to handling, to testing, proteins often require thinking creatively to achieve an acceptable stability program.

This accredited 12-hour intensive course provides comprehensive and up-to-date knowledge of developing and executing compliant and effective stability programs for protein and peptide biopharmaceuticals and biologics. The course covers both US FDA and EU EMA regulatory and technical expectations and activities to fulfill those expectations, with the biotechnology guidelines of the International Council for Harmonization (ICH) receiving special attention.

The approach of the course is practical as well as theoretical so that attendees will be able to plan, accomplish and review stability studies and programs. Attendees will have the opportunity to apply what they have learned during a workshop in which participants join the instructor in planning model stability programs for relevant product types.

Can’t Make the LIVE Course dates?

You can register now for the on demand! Simply select the On Demand option when registering and we will automatically send you access to the recorded version for you to view for 30 days. On Demand will be available within 2 weeks after the live offering.

PLEASE NOTE: Since this training is highly interactive, you must have a webcam on your computer equipped with a microphone and speakers/headset in order to fully participate.