Conference Day One

7:45 am Chair’s Opening Remarks

Supercharging Upstream Process Development to Minimize Cost of Goods and Maximize Product Consistency

8:00 am Case Study: Identifying Critical Quality Attributes to Ensure Clinical Safety and Efficacy

  • Pooja Mehta Senior Scientist, Immatics Biotechnologies


• Defining critical quality attributes for your cell therapy such as polyfunctionality, cytokine secretion, persistence in line with IHC guidelines
• Designing assays to measure critical quality attributes and ‘global picture’ of your cells, and finding the best markers
• Considering how critical quality attributes and the assays used to measure them translate to a clinical setting
• Feeding back from the clinic to inform assay design

8:30 am Case Study: Expanding Cells to Retain Desired Product Characteristics


• Minimizing or removing the expansion phase and examining the impact on cell count and product implications
• Managing heterogeneous cell starting materials and developing reactive expansion and manufacturing protocols to funnel heterogeneous cells to homogenous products
• Scaling expansion and identifying more ‘gentle’ cell processing techniques to maintain critical quality attributes

9:00 am Driving the Wave of Non-Viral Engineering to Minimize Time, Complexity and Cost of Processes


• Discussing how non-viral engineering changes the overall process vs. viral-engineered cell therapies
• Examining safety profiles and the consequences of unintended editing, and setting up processes to mitigate risk
• Starting with the end in mind to design scalable, cost-effective, reliable processes for high-quality cell production using next-generation technologies from early-stage development

9:30 am Case Study: Creating and Closing Processes for Next-Generation Cas9-Engineered T Cell Therapies with Large Payloads


• Integrating large modules and circuits into T cells with DNA plasmid vectors and Cas9 engineering
• Closing processes to increase sterility, process control, and safety
• Discussing the challenges of leveraging novel engineering technologies in process development, and sharing lessons learned so far

10:00 am Morning Refreshments & Speed Networking

Streamlining Processes to Minimize Time and Cost of Production

11:00 am Case Study: Convening on Regulations to Establish Frameworks and Best Practices for the Industry


This deep-dive will be a series of presentations, roundtables, and problem-solving group activities to provide a framework of experience with regulatory filings in Europe and South America, and to discuss key questions for the field with the session leaders to help guide your own regulatory journey.
• Communicating processes and aligning with regulatory requirements and achieving compliance with SOPs and controls
• Discussing the published guidance on process development for cell therapies
• Highlighting the gaps in how generalized regulations apply to process development
• Generating supporting documentation in process development to justify changes from PD to QC
• Highlighting the different experiences in Europe and the US with materials, quality and process requirements
• Managing the evolving regulatory environment alongside product heterogeneity and developing assays and processes to enable flexibility

TECHx Talks


Each speaker will have 15 minutes to present their ‘use case’ for a novel technology, how they implemented it, what challenges they faced, and what they learned through this process development with novel tech

12:30 pm Discussing How Product Characteristics Can Streamline Process to Improve Process Simplicity and Reduce COGS


• Characterizing tumor infiltrating lymphocyte product expressing membrane bound IL15 and impact of process on product quality
• Improving process design to leverage product characteristics and optimizing cytokine supplementation
• Discussing challenges and lessons learned in this process development, and benefits from cytokine regimen optimization


12:30 pm Case Study: Moving Tech In-House to Reduce Reliance on Third Parties

  • Nathan Moor Associate Director, Engineering & Automation, Takeda


• Developing tech in-house, to automate and build out digital systems and reduce third party expenditure
• Outlining the journey through development from building a business case, building teams, and developing tech

1:00 pm Lunch & Networking

Advancing Allogeneic Process Development for Scalable Off-the-Shelf Cell Therapy

2:00 pm Bringing Allogeneic CAR-T Cell Therapies to Fruition by Developing Strategies for Multiplexed Engineering using chRDNA Genome-Editing Platform


• Creating processes to produce highly efficacious allogeneic cell therapies with potential to expand to new markets
• Sharing engineering strategies to enhance persistence of allogeneic cells that may translate to improved clinical outcomes
• Establishing dosage requirements to inform batch size and manufacturing scale for off-the-shelf therapies

2:30 pm Case Study: Establishing Processes for iPSC-Derived Cell Therapies and Managing the Drug Product Workflow

  • Chris Deborde Process Development Engineer, Century Therapeutics


• Achieving and maintaining the most pluripotent state, and reflecting ‘natural’ cell phenotypes upon lineage differentiation
• Scaling up iPSC-derived therapy platforms, outlining the number of batches produced and how to define a batch
• Transferring manufacturing processes from auto to allo, identifying areas of synergy to streamline needs for training, GMP space
• Demonstrating safety and purity of iPSC-derived products for clinical application

3:00 pm Panel Discussion: Reflecting on the Trials, Tribulations, Victories and Remaining Hurdles in Process Development Across Contrasting Allogeneic Sources


• Contrasting the process development steps, and relative advantages and pitfalls between different allogeneic sources from iPSC-derived, healthy donor, and umbilical cord-derived cells
• Highlighting synergies and learnings that can be applied from the autologous field, and areas where innovation and a ‘clean slate’ is required to optimize platforms
• Sharing experience of process development for allogeneic cell therapies: the trials, tribulations and opportunities

3:45 pm Case Study: Scaling Up Allogeneic Therapies to Move Towards Industrial-Scale Production and Defining a ‘Batch’ for Off-the-Shelf Products


• Establishing the fundamental characteristics of an allogeneic platform
• Developing flexibility in processes to enable scalability through phases in line with market need
• Formulating and freezing large batches, defining a ‘batch’ for allo therapies, and communicating this with regulators
• Managing scalability with a limited donor pool of minority cell populations, and demonstrating product safety and efficacy at scale

4:00 pm Chair’s Closing Remarks

4:15 pm End of Day 1