The Bioprocessing Summit

CONFERENCE SERIES: Bioprocess & Manufacturing

Recorded at: The Bioprocessing Summit

Digital Course: Accelerated Stability Testing of Biologics

 


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About this Product: 

This short course will aim to guide the researcher in designing studies for accelerated stability testing of biologics. The course will begin with basic underlying concepts governing protein drug product stability, and focus on design principles for meaning stress and accelerated stability testing of not only the protein of interest but also of excipients and primary packaging components. Strategies to handle complexities arising from their interactions will also be discussed.

 

 


Product Details:
1 Presentation
34 Slides
92:40 Minutes
Individual: $345
Site License: $1380

Formats Available:
Digital Download
 
On Demand 
DVD 

       

Agenda at a Glance: 

  • Attributes of a successful protein drug product
  • Modes of protein degradation: conformational stability, colloidal stability and chemical stability
  • Chemical degradation reaction
  • Real-time/accelerated/stress stability testing: rational design of stability conditions
  • Stressors for evaluating protein stability
    • Temperature: Arrhenius and non-Arrhenius kinetics
    • pH: coupled effects of pH and buffers
    • Interface: effects of protein stability: solid/liquid, liquid/liquid and liquid/gas
    • Oxidizers
  • Developing predictive and correlative tools: utility, desired features and examples
  • Excipients
    • Degradation mechanisms
    • Impact on protein stability
    • Factors to consider during stress/accelerated testing
  • Primary packaging
    • Accelerated stability testing
    • Extractable/leachables


Speaker Biography: 


Yatin R. GokranYatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India

Yatin is Narotam Sekhsaria Distinguished Professor of Chemical Engineering at the Institute of Chemical Technology (ICT), Mumbai. Previously, Yatin was Associate Director & Head of the Pharmaceutical Process and Technology Development department at Genentech, and has over 15 years of industry experience with prior tenures at Amgen, and Pfizer. He has direct experience with multiple successful BLAs, PASs, CBE-30s, and INDs, and has broad expertise in biopharmaceutical drug development spanning lead candidate selection to licensure. At ICT, Yatin’s research focuses on developing protein & vaccine delivery technologies for the developing world, and on problems of therapeutic protein stability.

About the Conference: 

The Bioprocessing Summit brings together international leaders to discuss today's bioprocess issues from cell line selection to manufacturing. The Summit provides practical details in a relaxed, congenial atmosphere that promotes information exchange and networking. This leading bioprocess meeting is hosted in Boston each summer along the lively and cosmopolitan harbor waterfront with its restaurants, cafes, museums and art galleries, and within easy reach of historical sites, Faneuil Hall and the famed North End.