Biopharmaceuticals: Introduction to Large Molecule Therapeutics Training Course (T66)
Overview
This new instructor led course introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product. The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and analytics. The need for Quality by Design in all aspects of biopharmaceutical development will be emphasized. Lastly, we’ll 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 market.
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
- Overview of the Biopharmaceutical Development Process
- Early Phase Development
- Late Phase Development
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
- Members focused on manufacturing risk assessment/mitigation
- Quality assurance and quality control specialists
- Validation specialists
Additional Course Details
Communities of Practice (COP)
This training course will be of particular interest to:
- Existing members of the Biotechnology CoP
- Future members of the new Advanced Therapy Medicinal Products (ATMPs) CoP
- Existing and future members of the ISPE Process/Product Development CoP
Daily Schedule and Pricing
This course is not currently scheduled, but may be offered at your company site.
Please contact ISPE for more information