Stability Testing for Protein Drug Products & Substances

Duration: 12 Hours
Course Instructor

Dr. Pardeep K. Gupta

$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

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 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:

  • Explain the US FDA and EU EMA regulatory expectations, ICH Guidelines, and technical issues surrounding protein and peptide stability testing
  • Establish, carry out, audit, and review Stability Programs which determine and monitor the shelf lives of Innovator and Biosimilar protein and peptide drugs
  • Recognize key structural and functional instabilities of proteins and peptides to facilitate planning your testing program, and know why
    these instabilities are important for safety and efficacy
  • List the elements of Stability Protocols and Stability Reports and have the expertise to write and review them
  • Handle Out of Specification (OOS) and Out of Trend (OOT) stability results and review the compliance and non-compliance of how others have dealt with these always-present issues
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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:

  • Stability Departments
  • Research and Development
  • QA and QC
  • Regulatory Affairs
  • Production

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.

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 Courses


Team Training

When 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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