Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
Duration : 90 Minutes
Gwendolyn Wise-Blackman,
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method De Read more
All drug substances and drug products require expiration dating. Data used to support and set expiry and shelf life must be collected and analyzed using guidelines set by regulatory agencies. Processes and considerations for small molecules are inadequate for large molecule therapeutics when planning for expiry dating. One issue to consider is that the complexity of large molecule therapeutics allows for a greater potential to lose potency through multiple pathways. This webinar addresses issues present when designing and implementing a stability program for large molecule therapeutics. Key topics will be addressed to provide insight into important issues that should be considered to assure maintenance of potency during
Course Objectives:
• Understanding the difference between stability for small molecules and large molecules or complex drug products
• Regulatory Expectations
• Special considerations for biologic stability
• Designing and validating stability indicating method
• Implementing a stability program
• Expiry dating
Background:
As with small molecule therapeutics, biologics require testing for stability. Documenting the stability of the biologic in different storage conditions is essential for setting specifications for expiry and shelf life. Understanding the possible pathways where degradation may occur is crucial to designing an appropriate stability program. Developing and validating stability indicating methods that assess possible pathways of degradation is important for the success of any stability program.
Why Should You Attend:
Biologics, as well as small molecule pharmaceutical products, require expiry dating. Data supporting expiry dating
Course Outline:
• Defining biologics
• Degradation pathways
• Areas of concern for
• Setting strategy to control stability
• Testing CQAs
• Stability indicating methods
• Test conditions, including stress conditions
• Data requirements
• Considerations for expiry dating
What You Get:
• Training Reference Materials
• Live Q&A with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Early Development and Product Design Personnel
• Process Design Personnel
• Quality Control Analyst
• Quality Assurance Personnel
• Lab Management
• Stability Personnel
• Manufacturing Personnel
• Shipping and Distribution Personnel
• Regulatory Affairs
• Drug Packaging Personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
