Implementing a Stability Program for a Biologic

Duration: 60 Minutes
flat 50% off on this webinar
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.
Biologic stability
Product ID: 508572
Objectives of the Presentation
  • 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
Why Should you Attend
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.

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.

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
$375
Recorded Session for one participant
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • 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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