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 SHORT COURSE 5: ACCELERATED STABILITY TESTING OF BIOLOGICS


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

Instructors:  

 Yatin R. Gokarn, Ph.D., Drug Product and Device, Biologics Development, Gilead Sciences, Inc.

Vishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.  

Speaker Biographies: 

 

Yatin R. GokarnYatin R. Gokarn, Ph.D., Drug Product and Device, Biologics Development, Gilead Sciences, Inc.  

 

 

 


 

Vishal C. NashineVishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.  

Dr. Nashine received his M.S. degree in Bio-process Technology from Mumbai University, followed by a Ph.D. in Medicinal Chemistry and Molecular Pharmacology from Purdue University, and post-doctoral studies in Protein Biochemistry at Pennsylvania State University. He also has several years of exposure in the areas of Fermentation Technology, Downstream Processing, and Molecular Biology. He is currently a Senior Research Investigator in the Drug Product Science & Technology department at Bristol-Myers Squibb with experience in early and late stages of product development. 

 

 


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