Amplify Your Bioprocess: Process Intensification for Downstream Processing (PI-DSP)
Guided Learning at Your Own Pace with Experts
This course will provide you with the necessary understanding on process intensification and its benefits in downstream processing, the related pain points, important considerations when introducing intensified processes, and the implementation at different stages
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
- 99% recommendation rate from previous learners
Duration:
45 -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 gene therapy. Fluent English is essential for optimal learning.
Upon completion of this course, you will understand how process intensification is applied in downstream processing.
This online course consists of both self-paced and collaborative learning units, allowing you to fit in learning around your work schedule. Each chapter includes live discussions, assignments, access to experts and Q&A sessions, using an interactive and collaborative platform to facilitate knowledge exchange between participants.
Focus Topics & Agenda
How is the Sartorius Academy’s Amplify Your Bioprocess: Process Intensification for Downstream Processing course structured?
Kick-off |
Introduction to downstream processing steps and technologies |
Introduction to Downstream Intensification |
Process Development and Scale-up of intensified DSP processes (intensified batch, connected, and Continuous) |
Bioprocess 4.0 |
Start with the end in mind in manufacturing |
Intensification for new modalities to describe what is possible there and how we can translate the learning from mAbs into DSP processes for new modalities |
Wrap-up |
Learning Modules
Duration: 2.0 weeks
Overview of DSP technologies
- Harvest/clarification (Depth Filtration, centrifugation, tangential flow filtration)
- Chromatography (Affinity, Ion Exchange, HIC, Multimodal, Bind & elute, flow-through)
- TFF/crossflow/SPTFF
- Virus clearance (Low pH hold, Chromatography, Filtration)
- Non chromatographic purification e.g. Precipitation/crystallization
Duration: 2.0 weeks
- Definition / explanation of process intensification
- Recap of upstream intensification scenarios
- Overview of downstream intensification levels and corresponding scenarios
- Intensification Techniques and Technologies at Harvest/ Clarification
- Intensification in Chromatography
- Intensification of Virus Clearance (low pH, Filtration)
- Intensification of UF/DF
Duration: 2.0 weeks
- Small scale model approaches for early downstream process development. Linked to UPS options to get an early view on an entire process and provide an effective feedback loop to the cell line developers at the beginning of a process
- Scale up considerations, risk profiles and mitigations
- Using the examples for Intensified Upstream take the outputs into a range of DSP scenarios to highlight and discuss pros and cons
- To understand and explain the options and respective risk profiles
- Analyze the potential outputs of the DSP processes in terms of quality and throughput
- Demonstrate the overall effectiveness of the intensified scenarios
- Overall intensification strategies and discuss optimal approach
- Batch definition in intensified DSP
- Overview of regulatory view/perception of intensified DSP
- DSP development – intensified batch unit operations, connected or continuous processing
Duration: 2.0 weeks
- Trends and drivers
- Current automation bottlenecks
- Automation framework for integrated bioprocessing
- DSP process manufacturability and process controls in batch and continuous processes
- Small scale model approaches for early downstream process development. Linked to UPS options to get an early view on an entire process and provide an effective feedback loop to the cell line developers at the beginning of a process
- Scale up considerations, risk profiles and mitigations
- Differences in batch mode chromatography process control vs. continuous chromatography process control.
- Data analytics with case studies
- Mechanistic modeling tools
Duration: 2.0 weeks
- Conceptual design tools
- Process modeling and facility layout principles for intensified bioprocessing
- Solutions for media and buffer management (concentrated buffers, ILD, ILC, predictive software, etc…)
- Footprint and product mass index (kg material / g product) analysis for intensified processes
- How mechanistic modeling can be effectively used to predict the continuous process performance in terms of process productivity and capacity utilization
- Replacement of experimental optimization with hybrid process development approach involving integration of experiments with models
- Time and cost saving due to hybrid process development approach
