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Short Courses

Comprehensive Characterization of Biotherapeutics (Innovators and Biosimilars) in the Context of Modern Regulatory Science

With the very positive responses received from our previous participants, the Barnett Institute is working on their third short course on biopharmaceuticals (Date not set).

This useful and informative course will provide attendees with current and future methods for comprehensive characterization of biopharmaceutical products.

One focus will be on protein structure, types of modification, and the potential role of these changes in on protein function. Methods of characterization will include liquid chromatography (LC), capillary electrophoresis (CE), LC/MS (mass spectrometry), and CE/MS.  A half day will be devoted to the latest approaches to carbohydrate analysis. The final day will focus on protein characterization in a regulatory environment.

The faculty includes leaders of regulatory science from industry and the FDA and distinguished bioanalytical scientists who are at the forefront of their fields.

This course is designed for individuals with and M.S. or Ph.D. degree in Chemistry, Biology, Pharmaceutical Science or related fields. Experience in protein chemistry and biopharmaceuticals is important. The course will be useful for laboratory personnel and those involved in the regulatory process.  Attendees will be introduced to state of the art technologies in separation, mass spectrometry, carbohydrate analysis and protein degradation pathways.

Distinguished Faculty for the 2011 Short Course

• Barry Karger
  Director, The Barnett Institute
  James L. Waters Chair in Analytical Chemistry, Northeastern University

• William Hancock 
  Faculty Fellow, The Barnett Institute
  Bradstreet Chair in Bioanalytical Chemistry, Northeastern University 


• Sunny Zhou
  Faculty Fellow, The Barnett Institute
  Associate Professor of Chemistry & Chemical Biology, Northeastern University  

• Steven Kozlowski
  CDER, FDA, Silver Spring, MD USA
  Quality, Quality by Design, Biotechnology Products and US FDA Initiatives

• Rohin Mhatre
  Vice President, Bioprocess Development
  

• Pauline Rudd 
  Conway Institute, NIBRT
  Dublin, Ireland