Course Instructor
Dr. Pardeep K. Gupta
Professor of Pharmaceutics, Philadelphia College of Pharmacy, University of The Sciences in Philadelphia (USciences)
Dr. Pardeep K. Gupta’s CoursesNo 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 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.
Upon completion of this course, you will be able to:
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This course is designed to serve the needs of professionals working on Innovator and Biosimilar Protein and Peptide stability during development, regulatory filing, and for post-marketing studies. Because of its comprehensive content, this course will be valuable to personnel in:
Professionals who are involved in planning, conducting, reviewing, supervising, or managing protein formulations, manufacturing, and stability testing activities to determine shelf lives and retest dates of pharmaceutical proteins and peptides would benefit greatly from this training.
Dr. Pardeep K. Gupta
Professor of Pharmaceutics, Philadelphia College of Pharmacy, University of The Sciences in Philadelphia (USciences)
Dr. Pardeep K. Gupta’s CoursesWhen you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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