Drug Discovery of Biologics Primer 201
*This microcourse includes optional CPE Credits and is powered by Biotech Primer, a trusted leader in life science training that simplifies complex topics for non-scientists.
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Optional CPE Credit: 1.0
Overview:
Drug Discovery of Biologics Primer 201 builds upon the foundational knowledge of Drug Discovery of Biologics Primer 101, focusing on systematic insights into therapeutic antibody discovery. This course begins with the significance of antibody screening and structure-based affinity maturation, emphasizing antibody Chemistry, Manufacturing, and Controls (CMC) liabilities. Covering four therapeutic antibody classes, including immune checkpoint inhibitors, this class showcases the factors that influence early drug candidate selection. The data and transition criteria essential for advancing candidate drugs from the discovery phase to preclinical development are also covered.
- Section 1: Drug Discovery Workflow: Explore the critical stages of drug development, from identifying and validating drug targets to selecting and optimizing lead candidates. Gain insights into preclinical and clinical development processes in the pharmaceutical industry.
- Section 2: Affinity Maturation and CMC Liabilities: Dive into structure-based affinity maturation techniques, including targeted diversification, chain shuffling, and formulation. Understand the critical aspects of Chemistry, Manufacturing, and Controls (CMC) liabilities, covering issues like aggregation, solubility, immunogenicity, and glycation in drug development.
- Section 3: Early Drug Candidate Selection: Explore the influence of drug size and complexity on target interactions, criteria in the drug discovery process, and the role of in silico, in vitro, and in vivo models. Delve into the functions and structures of human immunoglobulins, focusing on Fc and Fab regions.
- Session 4: Antibody Diversity: Discover various therapeutic antibody classes, including canonical blocking antibodies, antibody-drug conjugates, antibody-like molecules, and immune response reactivators. Additionally, explore the essential concepts of cell banking, encompassing master cell banks and working cell banks.
- Session 5: Discovery to Development Criteria: Explore the in vitro quantitative activity profile, covering in vitro ADME studies, pharmacokinetic studies, and pharmacokinetic biomarkers. Dive into in vivo efficacy studies, safety/toxicity studies, and learn how to estimate clinical doses and evaluate candidate transition criteria.
By the end of the course, participants will be able to:
- Master the drug discovery workflow and align specific goals for successful development.
- Analyze the early drug candidate selection criteria and consider therapeutic antibody properties in the selection process.
- Utilize in silicon, in vitro, and in vivo models to investigate functional pharmacological activity.
- Demonstrate proficiency in the drug discovery considerations needed for the four distinct classes of antibody therapeutics.
- Investigate pharmacology data and transition criteria to determine which drug candidates are progressing into preclinical development.
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