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.
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.
Upon completion of this course, you will understand Process development, downstream technologies and their role in mAbs purification, analytics of mAbs and unit operations.
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 |
| Clarification |
| Capture Chromatography |
Virus Inactivation |
Intermediate and Polishing Chromatography |
UF/DF |
Virus Filtration |
Formulation and Storage |
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
- Centrifugation
- Centrifuges (batch and continuous)
- Depth filtration
- Tangential Flow filtration
- Nominal / Depth filters
- Micro filters/ Hollow fibres
- Harvest storage (equipment for harvest storage)
- Things to consider
- Clarification CPP and CQA's
- How- Science behind it (separating the molecules)
- Capture chromatography
- Why it is called as capture chromatography
- What are resins, membranes used for capturing the mAb's
- Capture (principle of each chromatography media)
- Things to consider
- CPP and CQA's
- Science behind it (capturing the product)
- Analytics of chromatography (understanding the chromatography profile)
- What is virus inactivation
- Science behind it (inactivating the viruses)
- Filtration of low pH AE (nominal filtration and sterile filtration)
- Intermediate chromatography
- Polish chromatography
- Things to consider
- CPP and CQA's
- pH adjustment of output
- Science behind it (process related impurities and product related impurities)
- Analytics of chromatography (understanding the chromatography profile )
- Tangential flow filtration
- How it's different from normal filtration.
- Understanding the TFF systems, cassettes, hollow fibers.
- Clamping force (torque)
- Normalized water permeability (NWP)
- TMP & CFR
- Things to consider
- CPP and CQA's
- Science behind it (product related impurities)
- Analytics of UF/DF
- Virus retentive filtration
- Understanding the virus retentive filters
- Pre filtration and filters used in this process.
- Things to consider
- CPP and CQA's
- Science behind it (removal of particles by pre filters to avoid damage to viral filter, removal of virus)
- How to prove the integrity of filter pre and post batch activity
- Excipients and its role
- Surfactants and its role
- Formulation buffer ad its role
- Target concentration adjustment
- Sterile filtration and integrity check
- Filling of drug substance (DS)
- Freeze thaw (principle of freeze thaw)
- Things to consider
- CPP and CQA's
- Science behind it (freezing and thawing and why FT)
- Analytics of freeze thaw
- Introduction to mAbs quality assessment
- Analytical testing
- Development
- Manufacturing
- Method description of main
