Full course description
Audience
This e-learning library is designed for anyone who wants to learn more about biopharmaceutical process development manufacturing. The content can be used as training for new employees, cross-functional learning for established employees, or as primer for those interested in joining the field. Basic knowledge of biochemistry and biology is recommended.
This e-learning library is designed for anyone who wants to learn more about biopharmaceutical process development manufacturing. The content can be used as training for new employees, cross-functional learning for established employees, or as primer for those interested in joining the field. Basic knowledge of biochemistry and biology is recommended.
Structure
This self-paced course is organized into modules. Learners may choose to complete the entire course in order, or may pick and choose relevant modules. The content is presented via narrated slides with transcript and includes animations, expert videos, equipment pictures and videos. “Test your knowledge” questions are included at the end of each module. The entire library contains approximately 3 hours of recorded content.
This self-paced course is organized into modules. Learners may choose to complete the entire course in order, or may pick and choose relevant modules. The content is presented via narrated slides with transcript and includes animations, expert videos, equipment pictures and videos. “Test your knowledge” questions are included at the end of each module. The entire library contains approximately 3 hours of recorded content.
- Course Introduction: Biopharmaceutical Manufacturing Overview
- Therapeutic Protein Structure and Function
- Module 1 Protein Structure Basics
- Module 2: Mechanism of Action
- Module 3: Structure and Function
- Module 4: Glycosylation
- Module 5: Protein Charge
- Product Quality Measurement & Monitoring
- Module 1: Product-related Impurities
- Module 2: Critical Quality Attributes & Stability
- Module 3: Analytical assays for Measuring Product Quality
- Module 4: CQAs, CPPs and Process Control
- Upstream Process Development & Manufacturing
- Upstream Overview
- Module 1: Transfection
- Module 2: Cell Line Development & Clone Selection
- Module 3: Cellular Metabolism & Growth Kinetics
- Module 4: Seed Train & Production Bioreactor Development
- Module 5: Harvest
- Module 6: Process Optimization & Scale up
- Downstream Process Development & Manufacturing
- Downstream Overview
- Module 1: Chromatography Principles
- Module 2: Chromatography Methods for mAb Purification
- Module 3: Viral Clearance
- Module 4: Ultrafiltration & Diafiltration
- Module 5: Process Optimization & Scale up
- Module 6: From Drug Substance to Patient
Deborah Goldberg is a lecturer in Chemical & Biomolecular Engineering at the University of Maryland, College Park, with six years of experience working in Biopharmaceutical Development at AstraZeneca. Ben Woodard has over 20 years’ experience in biopharmaceutical production, business development and technology transfer. He is an innovative training and workforce development professional with extensive experience in the design, delivery, evaluation, and enhancement of effective instructional programs.
Acknowledgements
The course was developed as part of a joint project between The University of Maryland and Merck, and was sponsored by the National Institute for Innovation in Manufacturing Biopharmaceuticals (also known as NIIMBL).