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Scaling production of cell based therapies (by Jan Calliauw & Thomas Degreef)

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Cell based therapy is the most promising innovation in medical. The biggest challenge? It’s a complex, extensive and manual production which results in a small scale and expensive treatment. We’ll dive in the technical challenges to automate and scale cell production and how cell transfection can be stimulated by the technology transfer of optics.

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Scaling production of cell based therapies (by Jan Calliauw & Thomas Degreef)

  1. 1. 5.3 Scaling production of cell based therapies 1 CONFIDENTIAL Innovation Day 2018CONFIDENTIAL SCALING PRODUCTION OF CELL BASED THERAPIES Jan Calliauw Business Development Medical Jan.Calliauw@Verhaert.com TRACK 5 - SPACE TECHNOLOGY FOR A BETTER WORLD Thomas De Greef Physics System Engineer Thomas.degreef@Verhaert.com
  2. 2. 5.3 Scaling production of cell based therapies 2 CONFIDENTIAL 1 2 3 4 CONTENT Cell based therapies? State of Things Challenges How space can help
  3. 3. 5.3 Scaling production of cell based therapies 3 CONFIDENTIAL CELL BASED THERAPIES: CREATING A BETTER WORLD Click to insert subtitle
  4. 4. 5.3 Scaling production of cell based therapies 4 CONFIDENTIAL Goal: locate, recognize and attack invaders Problems: • Malignant cells hide from immune system (eg. cancer) • Side effects of current treatments IMMUNE SYSTEM
  5. 5. 5.3 Scaling production of cell based therapies 5 CONFIDENTIAL IMMUNO THERAPY = reprogramming a patient’s immune system to better confront malignant cells
  6. 6. 5.3 Scaling production of cell based therapies 6 CONFIDENTIAL • 40% will be diagnosed with cancer • Better treatment • Less side effects • Vaccinating within reach • Stronger infectious diseases are emerging (swine flu, ebola, … ) • Personalized medicine HOW IT WILL CHANGE & IMPROVE THE WORLD Vaccinate Against cancer ?
  7. 7. 5.3 Scaling production of cell based therapies 7 CONFIDENTIAL STATE OF THINGS
  8. 8. 5.3 Scaling production of cell based therapies 8 CONFIDENTIAL Some mature cell based therapies • Stem cell transplantation • Blood transfusion Some just entered the market • Provenge (came & went) • Novartis’ Kymriah® • Kite Pharma’s Yescata® Majority in early development stage (clinical phase I or II) • Still an emerging field of science => Iterative learning • Eg. T-cells show efficacy after 20 years STATE OF THINGS
  9. 9. 5.3 Scaling production of cell based therapies 9 CONFIDENTIAL • Lots of new developments • 500 products in phase 2 trials DEVELOPMENTS: SOME THERAPIES
  10. 10. 5.3 Scaling production of cell based therapies 10 CONFIDENTIAL • Mostly labour-intensive lab processes • Automation of discrete process steps • Cell expansion in wave-type bioreactors • Cell selection/washing in closed filtration systems DEVELOPMENTS: MANUFACTURING
  11. 11. 5.3 Scaling production of cell based therapies 11 CONFIDENTIAL DEVELOPMENTS: AUTOMATION
  12. 12. 5.3 Scaling production of cell based therapies 12 CONFIDENTIAL Some Blue chip pharma invests MARKET HEAT
  13. 13. 5.3 Scaling production of cell based therapies 13 CONFIDENTIAL REGULATORY • Stringent requirements on environment & QC • Biohazard related to viral vector use • Process = product • Biological product is difficult to fully characterize • regulators put emphasis on process • automate has to replicate the manual process
  14. 14. 5.3 Scaling production of cell based therapies 14 CONFIDENTIAL AUTOLOGOUS CAR-T CELL THERAPY WORKFLOW
  15. 15. 5.3 Scaling production of cell based therapies 15 CONFIDENTIAL CHALLENGES
  16. 16. 5.3 Scaling production of cell based therapies 16 CONFIDENTIAL MAIN CHALLENGE Lower COGs to reach reimbursement point • Manual production in GMP compliant lab (50% of COGs) • Under investment in automation • Unjustifiable before proven clinical effect • Goal is to be acquired by big pharma • Results in high cost per treatment Be aware of cost drivers from the beginning
  17. 17. 5.3 Scaling production of cell based therapies 17 CONFIDENTIAL COST BASED APPROACH
  18. 18. 5.3 Scaling production of cell based therapies 18 CONFIDENTIAL CHALLENGES 1 Cell culture 5 Logistics for live cells 3 Contami- nation 4 Automation 2 Cell imaging
  19. 19. 5.3 Scaling production of cell based therapies 19 CONFIDENTIAL CHALLENGE 1: YIELD & CELL CULTURE Improve yield to treat more patients • Reduce batch failures • Produce more cells per batch • Produce stronger cells • Reduce in process cell loss • Quality control: IPC • Changing cells • Transducing • Transfection • Electrophoresis
  20. 20. 5.3 Scaling production of cell based therapies 20 CONFIDENTIAL CHALLENGE 2: CONTAMINATION Cost of disposable vs cost to clean, sterilize & validate. • Integrated cartridge – tube sets - pipetting • Potential to be fully closed • control of temp, humidity, CO2, ... • lower chance on contamination • lower grade lab (up to 50% of COGS) • Contactless • Prove fluid-path polymers have no adverse effect on the cells/therapy
  21. 21. 5.3 Scaling production of cell based therapies 21 CONFIDENTIAL CHALLENGE 3: CELL IMAGING Cost effective design of custom microscopes. • Optical alignment • Optimized imaging technology • Continuous view on cell growth • Non destructive quality control • IPC • Distributed QC (Intermediate & product stability)
  22. 22. 5.3 Scaling production of cell based therapies 22 CONFIDENTIAL CHALLENGE 4: AUTOMATION Automation of complex & lengthy lab processes • Integrated vs modular • Decrease operator variability • Increase operational efficiency • Improve product consistency • Reduce loss • Non destructive IPC on small samples
  23. 23. 5.3 Scaling production of cell based therapies 23 CONFIDENTIAL CHALLENGE 5: LOGISTICS FOR LIVE CELLS Short cell shelve life (raw material & therapy) Decentralized production or logistics • Cost • Supply of raw materials • Distribution of final product • Moving patient is risky
  24. 24. 5.3 Scaling production of cell based therapies 24 CONFIDENTIAL CREATING A BETTER WORLD HOW SPACE HELPS
  25. 25. 5.3 Scaling production of cell based therapies 25 CONFIDENTIAL WHY SPACE? Similar challenges • Effects in health of long term spaceflight • Contamination • Automation: (un)manned space BIOLAB Fluid Science LabISS
  26. 26. 5.3 Scaling production of cell based therapies 26 CONFIDENTIAL CHALLENGES SIMILAR CHALLENGES TACKLED 1 Yield & Cell culture 5 Logistics for live cells 3 Contaminati on 4 Automation 2 Cell imaging Availability & shelve life of cells SOME PROJECTS EPU Experiment Preparation Unit EPU Disposable unit Safety requirements Cell imaging Spectrometry On site monitoring Unmanned flight Fluidpac Thermal Control Units European Transport Carrier Protection of biological material (launch/landing)
  27. 27. 5.3 Scaling production of cell based therapies 27 CONFIDENTIAL EXPERIMENT PREPARATION UNIT EPU Cryogenic defreezing • -180°C to +10°C • Minimized cell loss Avoid contamination • Disposable with septum & shielded needles • Sterilization • Disposables with gamma rays • System 100ppm Ozone sterilization
  28. 28. 5.3 Scaling production of cell based therapies 28 CONFIDENTIAL Space observation => cell imaging • HYPE: retrofit hyperspectral module • Flumias: 4D cell monitoring for fast live-cell imaging in microgravity • Digital Holographic Microscope to monitor protein crystal growth CELL IMAGING
  29. 29. 5.3 Scaling production of cell based therapies 29 CONFIDENTIAL FLUIDPAC: UNMANNED FLUID SCIENCE LABORATORY • Automation • Closed system
  30. 30. 5.3 Scaling production of cell based therapies 30 CONFIDENTIAL BUBBLE-FREE FILLING • Performance of bubble free filling • Demonstrate absence of dead/trapped volumes
  31. 31. 5.3 Scaling production of cell based therapies 31 CONFIDENTIAL Goal: Open cell membrane to delivering exogenous material (i.e. transfecting cells) and change cell characteristics. Applications: cell biology research, cell-based therapies, crop modification, etc. Space tech: Architecture of confocal laser scanning microscope for 3D fluorescence imaging of biological samples. CELL PREPARATION-PHOTOPORATION
  32. 32. 5.3 Scaling production of cell based therapies 32 CONFIDENTIAL • Compatible with common cell culture substrates • Macromolecules too large to go through cell membrane • Minimal cytotoxicity Electrophoresis (alternative tech) causes 60-90% cell loss • High accuracy into cells Only technology that can focus on individual cells PHOTOPORATION
  33. 33. 5.3 Scaling production of cell based therapies 33 CONFIDENTIAL SPACE SOLUTIONS Spacesolutions.be
  34. 34. 5.3 Scaling production of cell based therapies 34 CONFIDENTIAL 1. Immunotherapy has great potential to cope cancer 2. State of the art is on its way 3. Cost is major bottleneck for wide roll-out 4. Space technologies can provide solutions CONCLUSION
  35. 35. 5.3 Scaling production of cell based therapies 35 CONFIDENTIAL WANT TO SUPPORT IMMUNOTHERAPY RESEARCH? uza.be/schenking
  36. 36. 5.3 Scaling production of cell based therapies 36 CONFIDENTIAL One group, five brands Our services are marketed through 5 brands each addressing specific missions in product development. INTEGRATED PRODUCT DEVELOPMENT ON-SITE PRODUCT DEVELOPMENT DIGITAL PRODUCTS DEVELOPMENT OPTICAL PRODUCTS DEVELOPMENT VENTURING

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