Holistic Study of Monoclonal Antibody Upstream Technologies
Self Learning at Your Own Pace
This course will provide you with the necessary understanding on mAbs, the various steps of upstream processing (USP) covering process development and scale-up, production and analytics.
It includes:
- Mix of self-paced and instructional units with 5-6 hours of learning per week (55 – 60 hours in total) over 2.5-3 months
- Interactive collaborative platform to facilitate knowledge exchange
- Limited synchronous activities allow participation from across the globe
Duration:
40 - 50 h
Self-Learning Program Available From:
Registration is open. Register your interest by filling out the form at the bottom of this page.
Lab managers, team leads, researchers, engineers and scientists with expertise in bioprocessing and basic knowledge of mAbs. Fluent English is essential for optimal learning.
Upon completion of this course, you will understand the various steps involved in upstream processing of mAbs.
This online course consists self-paced allowing you to fit in learning around your work schedule. Each chapter includes assignments, access to experts using an interactive and collaborative platform to facilitate knowledge exchange between participants.
Focus Topics & Agenda
How is the Sartorius Academy's Holistic Study of Monoclonal Antibody Upstream Technologies course structured?
Kick-off |
| Introduction |
QbD and Process Characterization |
Media, Clone, and Cell Line Development |
Process Development |
| Upstream Processing of mAbs |
| PAT (Analytics) |
Wrap-up |
Learning Modules
Introduction
- Antibodies – fundamentals
- Antibodies – trends, applications, milestones
- Biotech product life cycle
- Biotech industry landscape
- Biopharma regulatory landscape
- Biologics market landscape
- Typical mAbs manufacturing platform
- What is upstream processing
QbD and Process Characterization
- Identify TPP/QTPP
- Risk assessment
- Design space
- Control strategy
- Product life cycle management
Media, Clone, and Cell Line development
- Cell line development- overview
- Media characterization
- CLD trends
Process Development
- Upstream process development considerations
- Overview of different mAb processes
- Cell culture optimization
- Process optimization
Upstream processing of mAbs
- Seed Train and its considerations
- Production modes
- Objectives and challenges of upstream manufacturing
PAT (Analytics)
- mAbs Quality assessment
- Analytical testing
- Development
- Manufacturing
