Wednesday 19th March - Main Conference Day One - PT (Pacific Time, GMT-08:00)
- Hamza Ahsan - Senior Manager, MSAT, Vaxcyte, Inc.
- Wenjun Di - Senior Scientist, Downstream Process and Formulation Development, Ultragenyx Pharmaceutical Inc.
- Ohnmar Khanal, Ph.D - Downstream Technology Lead, Spark Therapeutics
We present a novel pilot-scale benchtop system that can run almost all major downstream purification processes, such as chromatography, tangential flow filtration (TFF), SPTFF, normal flow filtration, inline dilution, and various process intensifications (4C) and integrated processes. This platform features its powerful multi functionality with three key innovative process configurations and modular concept as well as a comprehensive industrial DCS control and data management framework in line with digital transformation. The system represents a transformative shift in bio pharmaceutical downstream processing and can play a critical POC role for tech transfer.
- Zuwei Jin - VP Business Development, Lisure Technologies
- Hamza Ahsan - Senior Manager, MSAT, Vaxcyte, Inc.
- Younghoon Oh - Senior Scientist, API Protein, Johnson & Johnson Innovative Medicine
- Jonas Immel-Brown - Scientist - Technical Development, Biogen
Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in different ratios to target a wide range of pore sizes. The complex nature of the raw materials gives each filter a relatively broad pore size distribution and provides some adsorptive capacity through charge and hydrophobic interactions. The filter media thickness, pore size distribution, and adsorptive capacity make them the ‘go-to’ technology in harvest applications where a product is separated from a complex cell culture fluid.
Recent work has highlighted the importance of how flow distributes within single-use capsules, and how capsule design can affect scalability. In this work, we take a deep dive into flow distribution through depth filter capsules using a combination of CFD modeling and experimental work. CHO cell culture streams, both direct and post-centrifugation, are used to assess performance parameters such as capacity, impurity removal, and yield. We will also present scalability data across a full range of process development-scale, pilot-scale, and manufacturing-scale depth filter capsules. This data will help process development scientists and engineers understand the structure of these devices, what parameters to focus on during development, and how to set appropriate safety factors during scale-up.
- Luke McCarney - Filtration Engineer, Cytiva
Novel modalities propose unique challenges for their purification and removal of impurities - how can purification processes be optimized for these novel modalities?
- Downstream processing considerations for modalities such as DNA/RNA/mRNA, viral vectors, ADCs, radiopharmaceuticals, and T-cell engagers.
- Key challenges in purification, scaling, and quality control.
- Innovative solutions and strategies for optimizing these processes.
- Attila Nagy - Associate Director – Downstream Process Development, National Institute of Health
- Maher Alayyoubi - Senior Principal Scientist - RNA Technology and Innovation, Arcturus Therapeutics
- Alpana Naresh, Ph.D. - Executive Director, CMC Operations, Harpoon Therapeutics Inc., a subsidiary of Merck & Co., Inc.