Bioprocess Optimisation and Scale-Up for Downstream Operations with Avantor

• Upstream advances impacting downstream operations and the need for process intensification/optimisation
• Basics of downstream process development for mAb/rproteins including clarification, viral inactivation, TFF and chromatography
• Viral inactivation with detergent treatment or low pH hold
• Chromatography process development for different types of chromatography techniques
• Chromatography step optimisation through DOE
• Continuous purification of mAbs/rProteins—Protein A capture and polishing chromatography
• TFF optimisation, membrane sizing, TFF skid with advanced fluid handling
• Implementation of single-use technologies with aseptic fluid handling in biomanufacturing
• Review of advanced fluid handling systems and parameters relevant to perfusion processes
• Harvest platforms – ATF/TFF single pass, centrifugation, depth filtration, spin filter, settlers, Ultrasonic systems
• Overview of sterile filtration, process compatibility and sizing study, filter integrity and validation

Special Equipment Emphasis

• Various pumping technologies encountered in traditional bioprocessing workflows (peristaltic, syringe, diaphragm, etc.)
• Highlight advantages and limitations of each pumping technology, with an emphasis of where, why and how to best implement each
• Discuss the importance of hardware scalability to enhance productivity and minimise downtime
• Considerations when specifying equipment (e.g., essential items needed; how best to decide which of the items are best for a given application)
• Key considerations when deciding between single-use tubing assemblies and in situ installed tubing assemblies – advantages and limitations of each
• Best practices for setting up and maintaining fluid pathway equipment, to minimise system shutdown and maximise productivity

Learning Outcomes and takeaway

On completion of the course, delegates will be able to:

• Assess their own workflows and identify areas of potential productivity enhancements
• Identify potential areas, design and optimise downstream process to improve process productivity and efficiency
• Identify critical attributes of aseptic fluid handling and recognise issues impacting overall productivity
• Develop and optimise fluid pathways, including pumps, sensors, tubing assemblies, etc.
• Identify areas where automation can be deployed to improve productivity and enhance production yield