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SC 6: Accelerated Stability Testing of Biologics

Tuesday, August 19, 2014 | 6:00 – 8:30pm

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 measuring 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.

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
     

Schedule:

6:00: Speaker Introductions
6:05: Speaker: Dr. Yatin R. Gokarn
6:40: Dinner Break
7:05: Speaker: Dr. Yatin R. Gokarn
8:05 Speaker: John Iannone
8:30 End of Course

Instructors:

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

John Iannone, Program Manager and Technical Specialist, Toxikon Corporation

Speaker Bios

YatinGokarnYatin 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, Yatinwas 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 focuseson developing protein & vaccine delivery technologies for the developing world, and on problems of therapeutic protein stability.

 

Iannone_JohnJohn Iannone, Program Manager and Technical Specialist, Toxikon Corporation 

John Iannone is a Technical Lead and Program Manager at Toxikon Corporation. Since joining Toxikon in 2004, Mr. Iannone has assisted several drug and medical device developers with the development of product safety testing strategies. His areas of expertise include biocompatibility testing of combination devices, material characterization, and study design for custom microbiological and extractable/leachable studies. His responsibilities focus on providing technical support in client interface regarding unique testing requirements and facilitation of sound technical risk assessments of medical devices. Prior to joining Toxikon, Mr. Iannone received his Biomedical Engineering degree from Boston University, where he later became a research engineer in the College of Engineering.