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Flexible Facilities for ATMPs
- 1. Manufacturing Cell Based Therapies using Modular Facilities Mike Katsis G-CON Manufacturing Inc.
- 2. 2 The Current Scenario The Needs The Possibilities The Examples Conclusion Agenda Buffer Prep Cold Storage Equipment Preparation Reagent Quarantine Released for Manufacture Warehouse/QA Quarantine Administration Offices Conference Lockers Lockers QA offices Lobby Conceptual mAb Production Facility Receiving Bioiogical Safety Cabinet 50 QC Laboratory QC Laboratory QC Offices Cold Storage SartoFlow UF/DF 1000 STR Bioreactor Buffer and Media Prep Sterile Filtration ISO 8 100 200 1000 650 500 500 500 500 Floor Scale Floor Scale Sartoclear L-Drum CNC Supply Corridor Class D Corridor AHU 1 AHU 3 AHU 1 AHU 3 AHU 1 AHU 3 200 200 Class B Class D BIB O CNC Biological Safety Cabinet Bench 10 Liter Cultibag AKTA Skid Palletainer Pass Through 50/200 Twin STR FlexAct 2 0 0 CO2 incubator Depth Filter LevMix 400 FT-16 Freezing Station Sartoflow UF/ DF LevMix 200 LevMix 50 Virus Filtration FT-16 Filling Station Transfer Cart Conceptual Design mAb Production Facility Mab Pilot Plant – 1000 liter 3900 square meters Proprietary GCON, LLC, 2012 DWG NO REV 1-CD-070812-rbh 1.1 SCALE SHEET 1 of 1 AHU 1 AHU 3 200 200 BIB O 500 500 QC Laboratory T Port BIB O Cell Expansion Cell Expansion and Harvest Downsteam Purification BIB O Clean Utilities Chillers, Boilers, Generator LAF Sterile Fill Vial Filler Washer Autoclave Liquid N2 Freezer -80 Freezer Master/Working Cell Bank
- 3. 3 The Current Scenario Expression rates go up, therapies are changing, which results in lower volume, smaller footprint, higher flexibility site needs Multi-product, multi-purpose sites are required to serve the biosimilar area. This also leads to more robust single-use process technologies and cleanroom segregation Regulatory view is changing and supporting agile, efficient and flexible manufacturing platforms Traditional sites cannot accommodate new therapy processing needs, which require: • Fast deployment, scaling and mobility • Robust containment and segregation • Decontamination possibilities, in conjunction with appropriate cleanroom construction materials
- 4. 4 The Current Scenario “Until now, modular facilities have reproduced traditional architecture with regard to embedding utilities piping and HVAC ducts in the interspace between the physical module limits and the suspended ceiling making refurbishment, if required, extremely complicated. The new approach is to segregate pre-assembled modules into laboratory and utility modules, which are designed such that they permit even simpler and faster construction, qualification, validation and maintenance, respectively….” Alan Pralong (2013) same inflexibility
- 5. 5 The Current Scenario, cont. • High CAPEX/higher OPEX • Long time-to-run (2-4 years) • Large volume, product dedicated • Scalable only with disruption of running processes and re-qualification • Extensive qualification needs • Difficult containment, lack of segregation due to interconnected ductwork • Difficult to sanitize • Difficult to clone, since materials and labor change every time • Immobile w/o option to relocate
- 6. 6 Regenerative/personalized medicines require specific processing systems in accordance with any possible logistic hurdles and robust containment needs The Current Situation – Questions Courtesy of GSK (2016) Courtesy of Novartis (2015) Questions prevail: How to produce ? Where to produce ? How to release ? How to control ? How to multiply ? How to ship ?
- 7. 7 The Needs Changing Therapies require Changing Mind-sets in Processing & Facilities & Logistics 10,000L – 15,000L mL – 50L Terminal sterilization by filtration Potentially only processed in closed aseptic process Large patient population Individual patient based Long development & planning cycle Rapid deployment Inventories Patient based immediate supply Time for release studies Immediate, rapid release to name just a few differences….
- 8. 8 Centralized or Decentralized ?!? The question of centralized or decentralized (hospital, cancer center, local based, logistics hub, airport location) is still debated (needle to needle logistics for example) Centralized (hub) Decentralized (hospital or cancer center)
- 9. 9 Start Centralized and Check… If the facility allows to start Centralized and after the initial investigation to Decentralize, the investment needs can be delayed or the structures can be leased Centralized (hub) Decentralized (hospital or cancer center) Take apart Re-assemble
- 10. 10 The Needs – Scaling w/o Interruption Flexible scalability, utilizing mobile autonomous cleanroom units reduces interruption of existing processes and can delay investment decisions *simplistic schematic Shell Building
- 11. 11 The Needs – Cloning (globally & locally) Cloning of Facility Platforms means Faster Deployment & Time-to-Run 24’ x 30’ Learning from the 1st built
- 12. 12 Prefabricated Possibilities Individual or clusters of prefabricated units are available Benefits: • Rapidly deployable • Mobile • Repurposable • VHP sanitizable • Robust containment • Segregated
- 13. 13 Existing Future Facility Examples Prefabricated OSD Site Prefabricated Aseptic Filling Site Courtesy: Pfizer Courtesy: University of Tennessee
- 14. 14 Conclusion Current, prevalent facility/process designs become outdated and strain to meet pressing industry requirements and application needs Facilities require to adopt mobility in case of processing and location decision delays ”Platinum standard” aseptic processing requires to be accommodated within robust and strict containment options Multi-product/multi-purpose facilities become a prevalent request to gain capacity utilization Facility deployment requires much faster (< 1 year built), mobile and possibly clonable
- 15. Thank you ! “The arrogance of success is to think that what you did yesterday will be sufficient for tomorrow” William Pollard [email protected]