Tuesday March 10 - PT (Pacific Time, GMT-08:00)
- Harish Venkatachalapathy, Ph.D. - Process Development Senior Scientist, Amgen
- 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
Achieving consistent, high-performance cell culture is fundamental to upstream bioprocessing, particularly for biologics manufacturing under accelerated timelines. This presentation introduces a comprehensive strategy for continuous optimization of an in-house developed Cell Culture Platform Media System (CCPMS), integrated with a comprehensive Quality Adjust Library (QAL) framework. The CCPMS provides a robust baseline for multiple host cell lines & product modalities, while QAL enables adaptive, data-driven refinement of media formulations to meet evolving process and product quality requirements.
Our approach leverages high-throughput experimentation and multivariate statistical modeling to identify critical nutrient interactions and optimize media composition for improved cell growth, productivity, and critical quality attributes (CQAs). The QAL acts as a dynamic repository of formulation adjustments, facilitating rapid iteration and knowledge capture across development cycles.
Case studies demonstrate significant gains in titer (≥ 10g/L), glycosylation consistency, and process robustness under tight timelines, highlighting the scalability and flexibility of this platform. By transitioning from static media design to a continuous optimization paradigm, CCPMS and QAL collectively enable faster development, reduced variability, and enhanced adaptability in a rapidly evolving biomanufacturing landscape.
Keywords: Cell culture media optimization, CCPMS, Quality Adjust Library (QAL), upstream bioprocessing, multivariate statistical modeling, continuous improvement
- Jara Lin, Ph.D., MD - Executive Director, BeOne Medicines
- Cassidy Cantin - Associate Partner, Latham BioPharm Group, Sia/LBGLatham
- Dawn Speidel - Vice President, Inventprise
- Dianne Cantara - Associate Manager, Latham BioPharm Group, part of Sia Partners
- Ben Mills - Senior Director, Operations (Joint Audit Program/Quality), Rx-360
- 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, Ph.D. - Postdoctoral Research Fellow, Rensselaer Polytechnic Institute
- David Scherr, Ph.D. - Senior Scientist, AstraZeneca
This panel will move beyond the “which is better” debate to address how leading companies evaluate and select the right upstream strategy across their portfolios. Experts will share case studies and business studies on decision-making frameworks, considering factors such as molecule type, clinical phase, cost of goods, regulatory expectations, facility readiness, and long-term scalability. Discussions will also explore the role of modeling, digital twins, and AI-driven analytics in simulating productivity and risk trade-offs between fed-batch, intensified, and fully continuous processes.
- Sanjay Kumar, Ph.D. - Senior Subject Matter Expert, Lonza
- Tim Gryseels - Principal Scientist, Pfizer
- Ken Lee - Senior Scientist, AstraZeneca
- Flaka Radoniqi - Process Development Principal Scientist, Amgen
- Ramakrishnan Gopalakrishnan, Ph.D. - Senior Manager, Fujifilm Biotechnologies
- Jochen Scholz, Ph.D. - Principal Scientist PAT, Sartorius Stedim Biotech
- Celia Jenkinson - Executive Director, Translational Pharmacology, Travere Therapeutics
- Raffaella Rossi - Consultant, FTM - AD
- Filomena Pirozzi - CEO and Founder, PURPLExCELL