Characterization of Proteins for Development and Approval of Protein Pharmaceuticals and Vaccines

Who Should Attend
This course will be of interest and value to scientists, supervisors, and managers whose work includes performing, supervising, or managing characterization of protein drugs and drug candidates during preclinical development, clinical development, and for post-marketing changes. Job titles include, but are not limited to:

  • R&D 
  • Protein Biochemistry
  • Quality Assurance 
  • Quality Control
  • Stability 
  • Formulation
  • Production

The course will also benefit Regulatory Affairs professionals who would like to learn the scientific background of this significant part of regulatory submissions.

Description
This course relates primarily to Monoclonal Antibody and rDNA Protein Therapeutics and Vaccines. The basics of protein chemistry/biochemistry will be presented since this knowledge is essential to the remainder of the course learning experience. The legal/regulatory requirements and expectations for molecular characterization of pharmaceutical proteins are detailed for the entire product lifecycle, from preclinical development through post-marketing changes. Essential analytical methods will be reviewed along with some "tricks of the trade" to enhance and streamline the efficient and effective use of these methods. Practical case-study examples and an opportunity for attendees to use their newlyacquired knowledge in simulated situations will be included.