Agenda March 17, 2027: Main Conference Day One - PT (Pacific Time, GMT-08:00)
- Cell Line Development is becoming a design discipline, not just a manufacturing-enablement step
- Cell line engineering turns molecule complexity into actionable design choices
- Speed is eliminating uncertainty earlier, not just doing every step faster
- How will AI/ML power next steps: from engineering cells based on what we know, toward predicting what to engineer next
- Zorica Dragic, Ph.D. - Unit Head Cell Line Screening and Development, Novartis
- Transient gene expression (TGE) enables rapid production of preclinical and clinical material with critical quality attributes comparable to that produced using stable cell lines.
- N-1 perfusion enables process simplification by decreasing expansion scale without sacrificing productivity in TGE workflows.
- mRNA-based TGE offers an alternative to traditional plasmid DNA, with the potential to further accelerate TGE workflows.
- Thomas Jacobsen, Ph.D. - GMP Scientist/Lead,, Duke Human Vaccine Institute
- Media and feed composition play a significant role in shaping CHO cell growth and productivity
- Optimizing nutrient supply can improve productivity without compromising product quality
- Cross-project and cross-scale learnings enabled informed nutrient management strategies and reduced reliance on empirical optimization
- Meghana Teli - Senior Research Scientist, Incyte Corporation
- Targeted media and feed optimization can improve fed-batch CHO process productivity while maintaining a robust and scalable upstream process.
- Feed composition, timing, and amount are critical levers for reducing fragment and protein heterogeneity levels by better managing nutrient availability throughout the production phase.
- A balanced development strategy is essential to address productivity and multiple product quality attributes simultaneously, rather than optimizing titer at the expense of molecule quality.
- Xiaolu Chen, M.D. - Associate Scientist IV, Alexion AstraZeneca Rare Disease
- Combination of automation and mechanistic modeling enables efficient acceleration of purification (even for challenging molecules)
- Mechanistic modeling facilitates transfer between non-clonal and clonal cell lines as well as tech transfer to pilot or manufacturing-scale
- Nanofiltration conditions can be optimally screened using automated DLS to enable challenging filtration, such as for hydrophobic molecules
- Scott Altern, Ph.D. - Senior Scientist II, AbbVie
- Intensified Harvest and Salt-Tolerant Capture Strategies
- Employing targeted analytics to track, identify, and quantify problematic host cell proteins across challenging purification stages.
- Predictive In-Silico and Mechanistic Modeling
- Kabir Dhingra, Ph.D. - Senior Scientist, Merck
- Richard Braatz, Ph.D. - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology
- Allogeneic cell therapy processes have the potential to scale production and reduce cost of goods.
- Bayer has developed 2D and 3D platforms, utilizing advanced automation and process control systems.
- These platforms are being applied to a Parkinson’s dopaminergic neuron cell therapy.
- Jason Dowd, Ph.D., MBA - Global Lead Cell Therapy Platform, Bayer
This work introduces a phase-dependent dynamic design of experiments (DDoE) framework for the systematic characterization and optimization of fed-batch cell culture processes. By aligning experimental factors with distinct stages of cell growth, the framework enables efficient evaluation of time-dependent feeding strategies and robust identification of feed timing and amounts that enhance process yield while maintaining key protein quality attributes. Relative to conventional DDoE approaches, the phase-based formulation reduces design complexity, improves the interpretability of factor–response relationships, and supports more informed process-development decisions. The framework therefore provides a practical, scientifically grounded strategy for accelerating development of robust and high-performing fed-batch processes.
- Tim Boung Wook Lee, Ph.D. - Senior Principal Scientist, Johnson and Johnson
- Delivering significant time and operational savings
- Increasing capacity
- Supporting a faster, more efficient, and scalable cell line development process
- Lina Chakrabarti, Ph.D. - Principal Scientist, BioPharmaceutical Development, Astrazeneca
The increasing complexity of cell culture processes has created a growing need for automation frameworks capable of implementing advanced process control strategies in a reproducible and efficient manner. To address this, a configurable automation framework was established across fed-batch and perfusion systems to support process control and reduce reliance on manual execution. Building on this foundation, we developed templates that enable implementation of diverse process control strategies and study designs across both platforms. For fed-batch applications, these templates leverage viable cell density, culture age, glucose concentration, and osmolality to automate feeding, process parameter adjustments, automated sampling, and execution of multivariate studies. For perfusion applications, custom calculations and decision-based logic enabled automated control of bleed, perfusion, and permeate operations. These configurable, standardized, and adaptable templates support the implementation of diverse control strategies and study designs across fed-batch and perfusion processes.
The flexibility of the framework was further demonstrated through integration of a capacitance-based biomass probe for real-time viable cell density monitoring. This capability enabled implementation of advanced control strategies such as live cell-specific perfusion rate (CSPR) control while providing continuous process visibility for automated decision-making. Collectively, by integrating automation and real-time process monitoring within a common framework, this approach expands the application of advanced process control strategies for cell culture process development.
- Poorvaja Ganesan - Associate Scientist 3, Alexion
Asymmetric bispecific antibodies require complex development to generate a final cell line expressing high abundance of the properly assembled product without delaying clinical timelines. Here we present a rational strategy for developing vectors that achieve proper chain stoichiometry via random integration, as well as a high-throughput screening strategy to identify high-producing cell lines with >90% chain-pairing purity on comparable timelines to traditional IgGs.
- Paul Rousseau - Sr. Engineer II, Cell Line Development, Biogen
- The work provides a robust cell line platform to eliminate xylosylation without compromising cell culture performance, productivity, and product quality, addressing a main developability challenge for GS linker containing complex biologics.
- Xylt2 knockout eliminates GS linker xylosylation in Chinese hamster ovary cells
- Xylt2 knockout CHO cells retain normal morphology, growth, and cloning recovery
- Xylt2 knockout had no negative impact on the productivity of recombinant proteins
- Xylt2 knockout preserved product purity and complex N-glycosylation and mucin-type O-glycosylation of recombinant proteins
- Xiaoyan Tang, MD - Principle Scientist, Merck & Co., Inc.
As portfolios shift toward more complex molecules, companies are rethinking how far CLD standardization can stretch. This panel will explore where platform approaches still create major speed advantages, where they begin to fail, and how teams decide when to customize.
- Digital twins are an important component of right-first-time tech transfer
- With digital twins, we can efficiently transfer complex processes from the laboratory to manufacturing scale and ensure consistent results at different manufacturing sites
- Improvements in and uptake of advanced process analytical technology will provide more opportunities for digital twins in the future and allow them to have greater impact
- Brooke Tam, Ph.D. - USP Modeling Expert, Sanofi
- Mechanistic modeling converted routine online process data and vessel-specific mass transfer characterization into actionable predictions of oxygen uptake and CO2 accumulation.
- Model outputs directly informed decisions about facility fit, antifoam strategies, and air sparging strategies needed to satisfy oxygen demand while managing pCO2 at manufacturing scale.
- Post-run comparisons were used to evaluate the original decisions and refine where additional model complexity was needed, including accounting for mass transfer effects of high cell density in intensified processes.
- Ashna Dhingra - Senior Scientist, AstraZeneca
- Live digital twins combine process data with mechanistic and machine-learning models to predict permeate and collection-tank titer during 50 L and 500 L perfusion runs, translating bench-scale models into manufacturing-scale insights.
- Combining four detection algorithms enables early warning of filter fouling, providing 8–24 hours of advance notice for all three observed filter-swap events and supporting timely intervention.
- Real-time dashboards and traceable alerts translate predictions into actionable process insights, establishing a foundation for agentic AI and future self-correcting biomanufacturing.
- Tianxin Zhang, Ph.D. - Senior Scientist, AstraZeneca
CMC Challenges with AAV and Cell therapy
Regulatory Landscape & FDA Fast-Track Enablers
Designing Platform Strategies Based on Program Scale
Process Changes & Comparability Planning
- Mahendra Rao, Ph.D. - Chief Scientific Officer, Vita Therapeutics
This forward-looking panel will separate meaningful next steps from hype in cell and gene therapy manufacturing. It will focus on the technologies and workflow changes most likely to materially change advanced therapy manufacturing over the next five years, including industrialization, in vivo delivery, automation, and data governance, and press panelists on what is actually deployable at scale versus still aspirational. The emphasis should be on practicality and what will actually change patient access.