Stability Testing of Proteins, Peptides & Other Biomolecules

This course is designed for Analytical Development, Quality Control, Stability, Formulation and pre-Formulation professionals involved in developing and running stability tests for proteins, peptides, and other biological molecules. 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 administering stability programs.

Learning Objectives

Upon completion of this course you will have gained a thorough understanding of regulatory expectations for stability testing programs and in-depth knowledge of U.S. and international stability guidelines. You will acquire expertise in recognizing key structural and functional instabilities to facilitate planning your testing program. You will know 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 U.S. 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.

Additional benefits of this class include:

• All participants receive a Resource CD with: a Reference List, 483s, Key Guidance Documents, and more.
• Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to anonymously submit their top challenges, problems, and issues for classroom discussion
• Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 15 years of industry experience, over 8 years of consulting experience, and over 10 years of experience directing training courses.

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COURSE AGENDA

DAY ONE

Session 1

Introduction
What are your top stability questions, problems, and issues?
Stability Terminology and Definitions
U.S. and International Regulations Pertaining to Stability

Session 2

Key FDA and International Guidance Documents
Review of protein and peptide structure
Degradation Pathways of Proteins and Peptides

Session 3

Stress Testing and forced degradation
Stability Assay Development
Validating Stability Indicating Methods

Session 4

Study Design and Acceptance Limits
Stability Protocols and Reports: Writing and Reviewing
Effective handling of Protocol deviations

DAY TWO

Session 1

Detailed discussion of participant questions, problems, and issues
Special Stability Topics
The Variety of Stability Testing Needed
Stability During Development
Validation/Qualification of Lab Equipment
21 CFR Part 11 and Stability Data

Session 2

When Things Go Wrong
Avoiding Common Stability Pitfalls
Review of Recent Stability Related 483s and Warning Letters
Handling OOS Results
Preparing for FDA Inspection of Your Stability Program

Session 3

Stability Workshop: mock validations of methods chosen by participants

Session 4

Shortcuts for Keeping Your Stability Knowledge Up To Date
Question and Answer Session
Course Wrap-up and Conclusions