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Biopharmaceuticals: Intro to Large Molecule Therapeutics

Overview

This new online course introduces participants to the development of biopharmaceuticals and it will cover concepts that highlight the differences between small molecules and biomolecules (large molecules). The purpose of this course is to provide a fundamental understanding of the CMC aspects of biopharmaceuticals from development to commercialization.

What You Will Learn

  • Biopharmaceutical CMC Development
  • Difference in Small Molecules and Large Molecules
  • Protein Complexity
  • Antibody Structure
  • Therapeutic Modality
  • Advantages and Limitations of Biopharmaceuticals
  • General Scheme for Biopharmaceutical Manufacturing
  • Analytics in Biopharmaceuticals
  • Cell Line Development (Mammalian and Microbial)
  • Cell Bank Creation and Characterization
  • Product Formulation
  • Analytical Methods
  • Regulatory Guidance
  • Isolators & Restricted Access Barriers
  • Quality by Design (QbD)
  • Validation
  • Comparability

Resources and Activities

  • Pre-Course Work Materials
  • Interactive Exercises
  • Learning Assessments

Course Modules

This 3 part series will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development with an emphasis on how they differ from traditional small molecule pharmaceutical development.
  • Part 1 - Introduction to Biopharmaceutical Development and Comparison to Small Molecules
  • Part 2 - Early Phase Biopharmaceutical Development and Comparison to Small Molecules
  • Part 3 - Late Phase Biopharmaceutical Development and Comparison to Small Molecules

CEUs are provided once you achieve an 80% passing grade and complete the evaluation.

The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.

Who Should Attend

  • Individuals who want to improve their working knowledge of biopharmaceutical development
  • Service organizations, suppliers, and vendors who serve pharmaceutical industry Clients focused on biopharmaceutical manufacturing
  • Academic institutions engaged in biopharmaceutical development/manufacturing
  • Vendors and suppliers of equipment/systems focused on the global biopharmaceutical launch process



*** Each course purchase is intended for individual use only and cannot be shared or transferred. If you need to make multiple purchases of this course for your colleagues, please contact Member Services at +1-813-960-2105 or by email, [email protected].
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