Holistic Study of Monoclonal Antibody Downstream Technologies
This course will provide you with the necessary understanding on mAbs, the various steps of downstream processing (DSP) covering process development, scale up, various unit operations at manufacturing scale and analytics.
It includes:
- Mix of self-paced and instructional units with 4-5 hours of learning per week (55 – 60 hours in total) over 3 months.
- Interactive collaborative platform to facilitate knowledge exchange
- Limited synchronous activities allow participation from across the globe
Duration:
55 - 60 h
Self-Learning Program Available From:
Registration is open. Register your interest by filling out the form at the bottom of this page.
Who Should Attend
Lab managers, team leads, researchers, engineers and scientists with expertise in bioprocessing and basic knowledge of gene therapy. Fluent English is essential for optimal learning.
What You Will Learn
Upon completion of this course, you will understand Process development, downstream technologies and their role in mAbs purification, analytics of mAbs and unit operations.
How You Will Learn
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 Holistic Study of Monoclonal Antibody Downstream Technologies course structured?
Kick-off |
Introduction |
Process Characterization |
Clarification |
Capture Chromatography |
Polishing Chromatography |
Ultrafiltration & Diafiltration UF/DF |
Virus Clearance |
Analytics |
Learning Modules
- Antibodies – Fundamentals
- Antibodies – Trends, Applications, Milestones
- Biotech Product Life Cycle
- Biotech Industry Landscape
- Biopharma Regulatory Landscape
- Biologics Market Landscape
- Antibody Purification Process Development and Manufacturing
- Introduction to Process Characterization
- Risk Assessment, Identification and Linking of CQAs and CPPs
- Design Space: DoE, Scale up and Scale down
- Control Strategy
- Clarification
- Centrifugation
- Mammalian Cells
- Filtration
- Factors Affecting Clarification
- Clarification Optimization
- Immunoglobulins
- Protein Purification Recommendations
- Three-Phase Purification Strategy
- Pre-requisites for Better Understanding of Chromatography
- Affinity Chromatography
- Ligands for Affinity Chromatography
- Affinity Chromatography | Prerequisites of Chromatography Purification
- Affinity Chromatography Process
- Challenges of Affinity Chromatography
- Multiple Chromatography Media Formats
- What if Membranes could Remove the Chromatography Bottlenecks?
- Increase Productivity with Membrane Chromatography
- Rapid Cycling Chromatography Concept
- Convective mass transport: Increased Productivity
- Protein Purification Recommendations
- Three Phase Purification Strategy
- Selection and combination of purification methods
- Know Your Protein - Characteristics of IgG
- Developing a Strategy for Purification
- Selecting a Suitable Method to Maximize the Yield
- Optimizing Protein Purification
- Learnings - Capture Chromatography & Low pH Incubation
- Intermediate Purification and Polishing Chromatography
- Considerations for monoclonal antibody purification
- Ion Exchange Chromatography
- Hydrophobic Interaction Chromatography
- Size Exclusion Chromatography
- Mixed Mode | Multimodal Chromatography
- Membrane Chromatography
- Monoclonal Antibodies Manufacturing Process
- Filtration Dimension
- Molecular Weight Cut Off (MWCO)
- Filters based on Size Cut Off
- Filtration Flow Direction
- Role of TFF in Bioprocessing
- UF/DF: Fundamentals
- How to Select the right TFF Membrane for Your Application
- Key Process Parameter Optimization
- Source of Viral Contamination
- The Consequences of Viral Contaminations
- Regulatory Requirements
- Viral Clearance
- Scope of Viral Clearance Study
- Virus Clearance Studies
- Viral Clearance Downstream
- Introduction
- Analytical Development vs. Process Development Approach
- Quality by Design Approach
- Risk Assessment by PHA
- Product Characterization
- What is important in Process Development and Manufacturing?
- Product Characterization During Process Development and Manufacturing
- Analytical Methods
- Microbial Analysis
