Conference Day Two

8:45 am Chair’s Opening Remarks

Evolving Downstream Process Development to Produce Uniform, Efficacious Cell Products

9:00 am Case Study: Finding the Right Scale for Allogeneic CAR-T Cells and Simplifying Processes to Balance Time and Quality at Scale

  • James Bolling Senior Director, Cell Therapy Process Development, Precision BioSciences

Synopsis

• Contrasting product quality and cell fitness at small vs. large scale, and strategies to create simpler, scalable processes with minimal compromise to fitness
• Balancing scale of expansion and achieving target product profiles to ‘find the right scale’ for product batches
• Experimenting with cryopreservation protocols to examine freezing profiles and optimize processes for the clinic

9:30 am Case Study: Optimizing Formulation, Fill, and Finish to Minimize Time and Maximize Cell Fitness

Synopsis

• Ensuring cell processing, mixing, fill, and finish are efficient, scalable, sterile and don’t impact cell fitness
• Minimizing time for fill and finish through novel technologies and automation
• Cryopreserving products whilst maintaining cell fitness, and qualifying technologies to optimize and automate cryopreservation

10:00 am Driving Manufacturing Process Innovation for Engineering and Expansion of Tumor-Infiltrating Lymphocytes

Synopsis

• Discussing the current state of TIL manufacturing processes and need for innovation
• Optimizing viral vector engineering of TILs for transgene expression
• Implementing novel feeders to support robust expansion of engineered TILs
• Innovating continuously for reduced COGS, close processing and automation

10:30 am Morning Break, Refreshments & Structured Speed Networking

Introducing Disruptive Technologies to Plug Gaps in Process Workflows

11:30 am Harnessing In Silico Modelling to Pre-Validate Experiments and Process Changes to Minimize Wet Lab Testing for Streamlined Process Development

  • Luisa Davies Senior Scientist, Manufacturing Technologies, Takeda

Synopsis

• Developing and validating in silico models to test process changes before testing in wet labs
• Discussing the advantages of in silico platforms, and the impact of implementing models on time and cost of development
• Considering areas remaining to develop and limitations of in silico models

12:00 pm Panel Discussion: Addressing the Gaps in Product Development and Cell Therapy Processes, and How to Move Forwards Together as a Field

Synopsis

• Debating the need to balance design of experiment and testing capacity, and optimal product with time and resources available
• Highlighting gaps in infrastructure to work on
• Identifying processes ideal for industry standards to create a platform for ‘best practice’ in process development
• Discussing critical process development elements such as potency assays, lentiviral vector activity to establish industry thresholds and standards

12:45 pm Case Study: Innovating Novel Digital Systems to Enable Data-Driven Product Development and Accelerate IND-enabling Studies

  • Amy Shaw Associate Director Process Development Cell Therapies, Takeda

Synopsis

• Combining process & product development with digital systems innovation to enhance process monitoring and control
• Leveraging automation in processing beyond closure and operational efficiency to extract real-time process data
• Defining data collection to meet IND-enabling endpoints

1:15 pm Lunch & Networking

Streamlining Processes for Commercial Scale

2:30 pm Case Study: Developing CAR-T Manufacturing Facilities to Produce Two Commercial Products Under One Roof

  • Pamela Wright Executive Director, CAR-T Manufacturing Operations, Bristol Myers Squibb

Synopsis

• Sharing lessons learned from developing dual-function facilities and carrying out process validation for two commercial products to licence on fast timelines
• Innovating facility use to reduce overheads and increase manufacturing productivity for multiple products
• Smoothing the transition from R&D to process development to brand-new commercial sites without compromising product quality

3:00 pm Managing Simplicity in the Process to Increase Leanness and Reduce Cost of Operations

Synopsis

• Identifying areas of redundancy and improving leanness of operations from preclinical products through product versions
• Implementing flexibility in process development to enable process changes with minimial impact on product
• Balancing process simplicity, practicality and prefection to ensure internal and external teams can follow SOPs easily whilst maintaining the best possible process
• Refining processes through development, setting milestones to review and improve between phases

3:30 pm Case Study: Managing Cross-Functional Teams to Translate New Processes to Manufacturing, Supply Chain, and Clinical Functions

  • Forum Bhatt Director CMC Strategy & Global Operations, Kite: A Gilead Company

Synopsis

• Building from process development to tech transfer to manufacturing
• Working with tech transfer departments to demonstrate reproducibility and precision
• Carrying out tech transfer when you have sufficient data to transfer your process, and generating SOPs to transition smoothly into a GMP setting
• Adjusting processes for CDMOs and tech transferring between manufacturing sites

4:00 pm Chair’s Closing Remarks

4:15 pm Close of Summit