Who Should Attend

This course will be valuable to those interested in how to set up a stability testing program specifically for peptides and proteins.  The course is appropriate for individuals involved in laboratory work as well as those involved in supervision, management, and direction of stability operations.  The course will also benefit Quality Assurance, Quality Engineering, Regulatory Affairs, and other compliance professionals involved in interacting with stability programs.



Learning Objectives

Upon completion of this course participants will have gained a thorough understanding of regulatory expectations for stability testing programs and in-depth knowledge of US and international stability guidelines. Attendees will acquire expertise in recognizing key structural and functional instabilities of proteins and peptides to facilitate planning your testing program. Additionally, participants will learn the key elements of a Stability Protocol and a Stability Report.

Course Description

This course provides comprehensive and up-to-date knowledge of stability testing for quality assurance and control of protein and peptide biopharmaceuticals and biologics. The course covers regulatory expectations regarding stability testing as contained in US and International regulations and guidelines. The guidelines of the International Conference on Harmonisation (ICH) will receive special attention and coverage. This course will prepare attendees to plan and execute effective and compliant stability programs. Attendees will have the opportunity to apply what they have learned during a workshop in which participants plan a stability program for one or more sample proteins/peptides.  In addition, there will be ample time to address the specific problems and questions of individual participants.

PLEASE NOTE: This course draws upon many (but not all) of the elements of the “Stability Programs for Product Shelf Life – From Development to Approval” course.  Included is additional instruction on protein structure (primary, secondary, ternary, glycoprotein), protein degradation, protein stability indicating tests, and protein protocol exercises.

View Course Agenda



Past Participant's Comments

““CfPIE courses are always worth my time.  They are always current, knowledgeable instructors with lots of “real” experience.  NOBODY reads from the slides!”  
Chandler W., Group Manager – Quality Management, Central Life Sciences

“Great course!  To the point, good pace, good material.  References were great – also, thanks for the slides.  today’s trends by FDA are worth the cost of the course.” 
John G., Research Scientist, Talecris Biotherapeutics

“The course director offered a lot of frank, honest, straight-forward advice about the realities of stability testing and GMPs.  For a small, young company like the one I work for, much of what I heard is scary, but it is what we need to be aware of.   The “Keeping Up” session at the end was particularly helpful.  You’ve given me much to think about, work on, and shoot for.”
Michael B., Scientist, Phage Biotechnology

“The Course Director did a great job in presenting a lot of useful information in a short period of time.  He was sure to focus on topics related to our interest without wasting time on other less relevant areas.  His presentation was well prepared, comprehensive and covered a significant amount of material.”
Michael U., Staff Biologist, Merck

“The course director was an excellent and enthusiastic tutor.” 
Tony H., Formulation Specialist, Smith & Nephew

“This course is excellent and much better than expected.  I learned a lot about stability testing and I will definitely use it from day one!”  
Steen B., Manager, Novozymes

“The course engaged people at different levels of knowledge and experience.  I know very little of the subject, yet did not feel lost at all.”  
David S., Application Systems Specialist, Merck

“This course helps me tremendously understand the technical and regulatory issues of stability testing of biomolecules.” 
Jianwei L., Principal Analytical Chemist, Medtronic Drug Delivery

“The Course Director was very well prepared – good engagement to a diverse audience.” 
Patrice D., Associate Director, Merck