Conference Day 1
Wednesday, May 10 2023

8:00 am
Welcome Coffee and Registration

9:00 am
Chair’s Opening Remarks

Optimizing Cell Line Development to Increase Scalability

9:15 am Fireside Chat: Discussing the Hurdles in Developing a Fully Scalable Cell Line

  • Sampath kumar Senior Director & Head of Cell Line Development, Takeda Pharmaceutical Co. Ltd.
  • Christopher Locher Chief Executive Officer, Versatope Therapeutics Inc.


  • Exploring approaches towards increasing the scalability of established cell lines
  • Tackling density thresholds, cell media and productivity decreases
  • Regaining control of cell lines, reducing genetic drift, and increasing stability

10:00 am Enhancing Cell Line Development & Bioprocess Optimization with Actionable Omics, AI, & Systems Biology


  • Understanding that high-throughput technologies are inherently observational, but can be adapted to inform cell line development and process optimization
  • Achieving actionable omics through properly designed experiments, AI, and systems biology to increase productivity
  • Integrating omics with an understanding of the cellular machinery, allowing for a connection between the intracellular metabolism and bioreactors or media to increase bioprocessing efficiency

10:30 am
Morning Refreshments & Speed Networking

Innovation in Cell Line Engineering to Regain Control of Expression

11:30 am Highlighting the Power of Using Transposases for Targeted Gene Integration


  • Encapsulating the ability of engineered transposases as a newer, faster and safer gene integration tool
  • Understanding the biological implications and mechanisms of semi site-specific integration
  • Exploring the impact of using transposases for gene editing on the timeline and scalability of Advanced Therapy Medicinal Products

12:00 pm Achieving Extremely Efficient Transgene Insertion to Gain Control of Expression


  • Using Sleek technology to increase the efficiency of gene knock-in via CRISPR
  • Harnessing the security and promoter strength of essential genes to gain control over expression
  • Reducing off target effects and variable yields with precise gene insertion

12:30 pm Extracting the Capacity of Automated Sense & Response Mechanisms to Control Conditional Gene Expression


  • Exploring how automated sense and response mechanisms can be used to optimise productivity and increase reliability of expression platforms
  • Understanding how aiming for inducible expression in mammalian cell lines could achieve greater control over expression levels and increase the versatility of various cell lines
  • Reducing toxicity and increasing productivity to enhance better scale up

1:00 pm
Lunch & Networking

Mitigating Cell Line Development Risks to Accelerate Regulatory Approval

2:30 pm Navigating the Pathway to Regulatory Approval for Advanced Therapies Using Cell Line Development

  • Mauricio Umana Senior Director - Regulatory Affairs, Chemistry, Manufacturing & Controls, Ring Therapeutics


  • Laying out the analytical measures and regulatory considerations required to produce a high quality product using mammalian cell lines
  • Exploring the changes in approach and analysis needed when using nonmammalian cell lines
  • Elucidating how variations in plasmid sources and choice of vector affect the regulatory hurdles encountered. Covering LVs, AAV and Anelloviral therapies

3:00 pm Assessing the Usefulness and Quality of the Stable Pool Approach for Achieving Clinic

  • Yves Durocher Head, Stable Cell Line Development for Manufacturing, National Research Council, Canada


  • Contrasting the stable cell pool approach with traditional methods in terms of scalability and speed
  • Using random integration to achieve biophysical and biochemical comparability to clones produced via target integration
  • Demonstrating how screening, assays and stability studies can be employed to reduce the risks posed

3:30 pm
Afternoon Poster Session & Networking

Understanding the Biological Hurdles to Increase Productivity

4:30 pm Panel: Tackling the Biological Hurdles Presented at Scale Up

  • Zhiwei Song Principal Scientist, Bioprocessing Technology Institute
  • Abhishek Chatterjee Professor, Boston College
  • Xiaozhi Ren Director - Cell Line, Process Development, Chemistry, Manufacturing & Controls, Vedere Bio


  • Addressing how the low yield caused by cell density and aggregation can be overcome
  • Eliminating batch variability: Why scale out is less preferable and less consistent
  • Regaining oxygen control at industrial scale to enhance cell growth and productivity

5:15 pm Employing Virus Based Delivery Platforms to Fine Tune the Expression Casette


  • Isolating limiting components to enhance the multi-component genetic circuit for unnatural amino acid incorporation.
  • Adapting virus assisted directed evolution of engineered tRNAs in mammalian cells to increase scalability
  • Progressing development of stable cell lines for unnatural amino acid incorporation

5:45 pm
Chair’s Closing Remarks & End of Day 1