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SHORT COURSE 4: QbD STRATEGIES FOR FORMULATION DEVELOPMENT OF PROTEIN THERAPEUTICS

 

Sunday, January 12 | 5:00-8:00 pm



This course offers a forum, discussing how to perform protein drug formulation development to meet Quality by Design expectations from the health authorities. A number of case studies will be presented to demonstrate how to design multivariate experiments, how to obtain dataset and how to analyze data in order to propose formulation of drug substance or drug product. The course will combine “how to” suggestions and real-world examples in an interactive discussion.

The topics to be covered:

  • QbD: Protein formulation strategies for regulatory filings
  • Force degradation and stability-indicating analytical methods
  • Application and utility of Design of Experiment (DoE) studies during early phase formulation development
    • Case Study 1 Incorporating flexibility around formulation composition to meet non-clinical and clinical demands
      • Post-screening formulation workflow
      • Study set-up, data analysis, investigation of interactions, formulation space, predictive model and projection
      • Clinical considerations during composition selection
       
    • Case Study 2 Contextualizing competing degradation pathways with the target product profile
      • Study design and Analysis
      • Accelerated stability studies and effective use of modeling tools towards variant qualification strategy
       
     
  • Case studies: Multivariate analysis of data table
  • Design space of protein drug formulation

 

Instructor:

Kevin Zen, Ph.D., Manager, Biologics Development, Allergan

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

 

Speaker Biographies

 

Kevin Zen, Ph.D., Manager, Biologics Development, Allergan

Kevin is a Manager, Biologics Development at Allergan. In this role, Kevin’s responsibility resides with separation sciences, characterization and formulation of protein therapeutics, as well as development of manufacturing process for clinical trial material and commercial products.
 
Prior to joining Allergan in 2009, he was an Associate Director at Catalent Pharma Solutions and Cardinal Health PTS, managing the chemistry, manufacturing and quality control activities that support analytical, formulation, structural characterization, and process development of the investigational recombinant proteins and monoclonal antibodies, as well as biosimilars. In the biosimilar arena, He has managed more than 10 biosimilars including Etanercept, Rituximab, Infliximab, Adalimumab, Bevacizumab, Trastuzumab, Cetuximab, Coagulation Factor VII, Coagulation Factor VIII, beta interferon, and Darbepoetin alfa starting from sequencing innovator’s drugs, cell line generation based on experimentally determined sequence of innovator’s protein drug, to protein analytical, formulation and characterization. Prior to Cardinal Health PTS, he worked in Becton Dickinson, AstraZeneca, and Johnson and Johnson.  He has over 20 years of biopharmaceutical industry experience in various disciplines directly related to protein therapeutics ranging from cell line development, protein expression, bioreactor, downstream process, analytical, formulation, and lyophilization cycle development. 


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

Dr. Nashine is a Senior Research Investigator in the Drug Product Science & Technology department at Bristol-Myers Squibb with extensive experience in early and late stages of biologics product development. Prior to joining BMS, Dr. Nashine completed his postdoctoral research in the laboratory of Stephen J. Benkovic at Pennsylvania State University where his experience included investigations on the role of protein conformational changes in catalysis and mechanistic understanding of DNA replication processes. Dr. Nashine received his Ph.D. in Medicinal Chemistry and Molecular Pharmacology from Purdue University and a M.S. degree in Bio-process Technology from Mumbai University. He also has several years of training and experience in the areas of fermentation technology, downstream processing, and molecular biology.
 


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