Biopharmaceuticals: Introduction to Large Molecule Therapeutics
Biopharmaceuticals: Introduction to Large Molecule Therapeutics Training Course
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
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
Additional Course Details
Communities of Practice
This training course will be of particular interest to:
- Existing members of the Biotechnology Communities of Practice
- Future members of the new Advanced Therapy Medicinal Products (ATMP) Communities of Practice
- Existing and future members of the ISPE Process/Product Development Communities of Practice
- Members focused on manufacturing risk assessment/mitigation
- Quality assurance and quality control specialists
- Validation specialists