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Tuesday March 10 - PT (Pacific Time, GMT-08:00)
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Tuesday March 10 - PT (Pacific Time, GMT-08:00)
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Recovery & Purification
8:55am - 9:00am
Chairperson's Opening Remarks: Recovery & Purification
9:00am - 9:30am
Designing Robust DSP Trains for High-Titer Bispecific Antibodies
- Renee Chen - Senior Scientist, AbbVie
9:30am - 10:00am
Utilizing Continuous, Connected Chromatography to Alleviate Downstream Bottlenecks Caused by Upstream Process Intensification
- Running multiple cycles on smaller chromatography columns in dual column mode, as well as connecting multiple unit operations together in continuous fashion is a strategy to enable processing of the additional mass entering the downstream process from intensified fed batch bioreactors.
- Continuous multi-cycle operation ensures that the processing time meets or even exceeds that of standard batch methods, enabling facilities to meet their required run rates without compromising purity or yield.
- The reduction in chromatography resin volume and buffer usage enables a reduced facility footprint and lower cost of goods of manufacturing, while also improving sustainability initiatives
- Chris Afdahl - Associate Director, AstraZeneca
10:00am - 10:30am
Efforts to Accelerate Pipeline Process Development for Downstream Phase 1-3
- Dimple Chavan - Senior Scientist, AstraZeneca
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Recovery & Purification
11:15am - 11:45am
Continuous Downstream Processing of mAbs via Precipitation
- Continuous downstream processing based on capture via target precipitation and polish via flowthrough chromatography offers a low cost-of-goods, low process mass index, and low complexity pathway to monoclonal antibody manufacture.
- Yield, purity, and throughput metrics for the precipitation-based process compare favorably to those for platform Protein A downstream processes.
- Capture via precipitation is broadly applicable to monoclonal antibodies and antibody-like therapeutics.
- The process development workflow in terms of selection of precipitant conditions and polishing resins is straightforward.
- Yuncan (Olivia) Zhu - Postdoctoral Research Fellow, Rensselaer Polytechnic Institute
11:45am - 12:15pm
10-fold Improvement in Depth Filter Capacity through Cycling Operation during Integrated Dynamic Bioprocessing (IDB) purification
- David Scherr - Senior Scientist, AstraZeneca
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Recovery & Purification
2:00pm - 2:30pm
Enabling Subcutaneous Formulations: A High-Throughput Computational (DeepViscosity) and Experimental (SAXS) Framework for Assessing High-Concentration Monoclonal Antibody Viscosity
- Lateefat Kayejaye - Graduate Research Assistant, Stevens Institute of Technology
2:30pm - 3:00pm
Challenges and Solutions to Manufacturing Low Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill-Finish Processing
- Vaibhav Deokar - Principal Scientist, Lupin Limited (Biotech Division)
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Recovery & Purification
4:15pm - 4:45pm
Assessment of Mass Spectrometry Platforms and Software for Host Cell Protein Analysis
- Jing Wang - Senior Scientist, Regeneron
4:45pm - 5:15pm
Case Studies on Utilizing Magnetic Resin with Self-Removing Tags to Improve Process Development
- David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
5:15pm - 5:45pm
Panel Discussion - Infusing AI into Downstream Processing
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
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