Nonclinical Development of Biologics


We are delighted that you have chosen the Therapeutic Modalities module to start or enhance your current educational journey in immuno-safety science. This lecture is one in a series of five providing detailed information on current and/or emerging therapeutics that interact with the immune system and is led by Dr. Melanie Hartsough of Hartsough Nonclinical Consulting. Please review the learning objectives below for more information on what you will learn in this lecture.
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Target Audience

This course is intended for the science professional or graduate student looking to learn the fundamental science and key consideration that are examined in immune safety assessment. Advanced topics and coursed that take a deeper dive into specific scientific areas will be offered and are recommended for the more experienced scientist who has a firm grasp of the information highlighted in the introduction module.

Learning Objectives

The learner will be able to:
  • Identify common themes for developing nonclinical programs for different biologic product types.
  • Understand at a high level the types of nonclinical studies required for different biologic product types.
  • Discern the clinical relevance of immunogenicity and immune reactions in animal studies for different biologic modalities.

Additional Information

Course summary
Available credit: 
  • 1.00 Participation
Course opens: 
Course expires: 

Lectures in this module

CAR Therapy
Safety Considerations for Oligonucleotides
CD3-binding (T cell engaging) immune stimulating antibody-based therapies
Gene Therapy
Nonclinical Development of Biologics
Melanie Hartsough, PhD
Hartsough Nonclinical Consulting, LLC

Available Credit

  • 1.00 Participation


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