Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

Duration: 90 Minutes
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 shelf life of the product.
Stability indicating methods
Product ID: 505789
Objectives of the Presentation
  • 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
Why Should you Attend
Biologics, as well as small molecule pharmaceutical products, require expiry dating. Data supporting expiry dating controls how long these products should remain on the shelf. To collect data that supports expiry dating drug substance and drug product must be thoroughly tested in stability indicating methods. Understanding the importance of these methods and the analysis and use of the data is necessary for personnel involved in product development, product testing, and product release.

Areas Covered
  • Defining biologics
  • Degradation pathways
  • Areas of concern for loss of stability
  • Setting strategy to control stability
  • Testing CQAs
  • Stability indicating methods
  • Test conditions, including stress conditions
  • Data requirements
  • Considerations for expiry dating
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
Topic 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.
$375
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  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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