Conference Day One: Wednesday, June 12, 2024

7:30 am Check-In & Coffee

8:30 am Chair’s Opening Remarks

Uncovering Key Challenges, Areas of Innovation & Promises for the Future

8:40 am Industry Leaders’ Fireside Chat: Insights from Industry Leaders on Overcoming Current & Future Challenges in Cell Therapy Process Development

  • Houman Dehghani Vice President - Technical Development, Cabaletta Bio
  • Jinlin Jiang Director, Cell Therapy Technical Operation, AstraZeneca
  • Dave Frey Vice President, Process Sciences, Atara Biotherapeutics Inc.
  • Paul Kopesky Vice President - Process Development, Beam Therapeutics


  • What are the key challenges currently hindering effective process development?
  • What challenges can we expect to arise in the next 5 years?
  • How can vendors help biopharma to pave the way forward? 

9:30 am T Cell Expansion Using Chemically Defined Media & Recombinant Proteins in Dynamic Cultivation Conditions

  • Deborah Maybruch Field Application Scientist, Life Science Business Unit, FUJIFILM Irvine Scientific


  • Exploring key considerations when selecting raw materials for cell culture media development
  • Reviewing T cell expansion in static and dynamic culture conditions
  • Outlining DMSO-free and chemically defined cryopreservation solutions for short- to long-term cell preservation

10:00 am Morning Break & Speed Networking


As this community re-unites for the third time, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections.

Implementing a Systematic Approach to Process Strategy for Optimal Outcomes

11:00 am Developing a Process in Line with Quality by Design Principles

  • E-Ching Ong Senior Scientist, Process Development, Lyell Immunopharma


  • Exploring Quality by Design (QbD): a step-by-step approach that investigates which factors may affect the quality of the final product
  • Putting QbD terminology to use: quality target product profile, critical process parameter, design of experiments, control strategy, process analytical technology etc.
  • Implementing an effective control strategy early on in development to ensure a robust process

11:30 am Finding the Balance: Developing a Phase Appropriate Manufacturing Process with Learnings from R&D

  • Aleks Guvenel Associate Director & Head of Process Development, Quell Therapeutics


  • Applying a phase appropriate method to process development: understanding “what” is needed and “when” it is needed for each phase of the drug development process
  • How do you transition effectively between research and process development groups?
  • How do you overcome challenges with lack of GMP grade materials? 

12:00 pm Presentation by Miltenyi Biotec



12:30 pm Lunch Break & Networking

Optimizing Starting Material Quality to Guarantee a Consistent & Robust Downstream Process

1:30 pm Starting Material for Autologous Cell Therapies: Beginning with the End in Mind


  • Ensuring patient centric process development: moving from healthy donors to patient material
  • Exploring monocyte depletion and/or T cell enrichment to manage the heterogeneity of the starting material
  • Selecting a cell population that ensures downstream process robustness

2:00 pm Starting Material Considerations for iPSC-Derived Cell Products


  • Utilizing a risk-based approach to address starting materials, donor eligibility, cell banking and genetic stability
  • Implementing phase-appropriate cell collection processes to obtain consistent, compliant, and high-quality starting materials
  • Interpreting FDA cGMP guidance for Phase 1 investigational drugs

2:30 pm Panel Discussion: Recognizing the Importance of Quality Starting Material for the Downstream Process


  • How do we reconcile the jump from healthy donor to clinical patient material?
  • How selective should we be with the starting cell populations?
  • How does cellular starting material variability impact downstream product quality? 

3:00 pm Afternoon Break & Poster Session


This is your opportunity to contribute to the conversation and share your cutting-edge research with this community while discovering exciting work carried out by your peers. To submit a poster, please contact

Overcoming Downstream Processing Challenges to Maximize Cell Product Safety & Efficacy

4:00 pm Investigating Methods for Visual Inspection to Maximize Patient Safety


  • Characterizing the particulates generated in the manufacturing process
  • Understanding how these particles impact the safety and efficacy of the cell therapy product
  • Exploring the current methods available for particulate detection and their effectiveness: visual inspection, light microscopy, flow cytometry, dynamic light scattering 

4:30 pm Exploring Best Practices for Cryopreservation of the Final Drug Product to Maintain Viability & Efficacy

  • Thong Cao Senior Process Development Engineer, Cell Therapy, Caribou Biosciences


  • Understanding and mitigating the effects of DMSO on cell viability
  • Deciding on an optimal freezing profile to maximize yield
  • Controlling cell viability across the thawing process following cryopreservation to maintain product efficacy

5:00 pm Panel Discussion: Navigating Challenges and Innovations in Cryopreservation for Cell Therapies to Improve Cell Viability & Function

  • Thong Cao Senior Process Development Engineer, Cell Therapy, Caribou Biosciences
  • Mark Lalli Associate Director, Process Development, Be Biopharma
  • Mary Keever Associate Director - Process Development, Inceptor Bio


  • What are the greatest challenges currently faced in cryopreservation?
  • What are the areas with potential for growth and optimization?
  • How are technologies for cryopreservation expected to evolve in the near and distant future? 

5:30 pm Chair’s Closing Remarks

5:45 pm End of Conference Day One