Design and Implementation of Biologic Stability Program
Duration : 60 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
This Biologic stability webinar will discuss the issues present during design and implementation of stability program for large molecule therapeutics. We will discuss the design and validation of stability indicating methods and expiry dating.
Course Objectives:
It is must that drugs delivered to patients maintain established potency and efficacy within specified time windows and hence all drug substances/products require expiration dating. The process of data collection & analysis to support, expiry and self-life need to be different for large molecules compared to small molecules as the complexity of large molecule therapeutics allows for a greater potential to lose potency through multiple pathways. This can occur during manufacture, transit, or storage.
Why Should You Attend:
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 shelf-life of the product.
Course Outline:
• Defining biologics - the difference between stability for small molecules and large molecules or complex drug products
• Degradation pathways
• Areas of concern for loss of stability
• Setting strategy to control stability
• Testing CQAs
• Stability Indicating Methods – Design and Validation
• Test conditions, including stress conditions
• Data requirements
• Considerations for expiry dating
What You Get:
• Training Materials
• Live Q&A Session 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
