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Mar 10, 2024 •490 likes •645 views

PCMM Portable, Continuous, Miniature and Modular Technology Rick Mitzner Senior Director, Engineering Technology Pfizer Global Engineering Pfizer Inc Sept 30, 2015 Portable, Continuous, Miniature & Modular A vision to transform SOD

  1. PCMM Portable, Continuous, Miniature and Modular Technology Rick Mitzner Senior Director, Engineering Technology Pfizer Global Engineering Pfizer Inc Sept 30, 2015

  2. Portable, Continuous, Miniature & Modular A vision to transform SOD Product Development and Manufacturing A standardized SOD technology platform used for development and commercial production. The system uses continuous processing , with state-of-the-art technologies , enabling flexible batch size providing production-on-demand . The complete ‘containerized’ POD-based facility is pre-engineered and assembled in the field for fast deployment. 2

  3. PCMM Development Approach • Open Innovation: platform available to the industry • Leverage commercially available technologies • Collaborate with key business partners – Pfizer – Equipment Supplier (GEA) – Portable Facility Supplier (G-Con) • Phase 2 collaboration planned 3

  4. PCMM OSD: A Factory in a POD Continuous Processing Platform Technology for Solid Oral Dosage Forms HSWG and CDC Skids Pre-fabricated in Belgium FAT in Belgium Shipped to Groton Building 90 Mock-up Integrated into a ‘Portable’ cGMP POD 6 Modules Pre-fabricated in College Station Texas … and re -assembled into a grey FAT in Texas space warehouse in Groton, CT Shipped to Groton

  5. PCMM Videos G-Con Video GEA Video 5

  6. PCMM OSD Prototype Processing Equipment Feeders CMT Feeders CMT Mixer Mixer Total Elevation Granule HSWG Wet Conditioning ~14.5 ft Granulation Unit Tablet Press Dryer Raw Continuous Mixing Material ConsiGma TM WG Dispensing & Direct Compression

  7. PCMM PAT and Product Diversion Diversion 1 Post Fluid Bed Drying PAT 1 (NIR) Post CMT Potency & Blend Uniformity PAT 2 (NIR) Post TSWG PAT 3 (NIR) Granule Formation Post Granule Sizing Potency & Granule Uniformity, Moisture PAT 5 (NIR) PAT 4 (FBRM) Feed Frame Post Granule Sizing Potency & Blend/Granule PSD Uniformity Diversion 2 Diversion 3 Continuous Mixing Post Granule Tablet Eject Chute ConsiGma TM WG & Direct Compression Sizing

  8. Batch to Continuous for OSD: Key Enablers & Differences • Loss-in-weight feeders – Low variability and high accuracy required • Integration/automation across unit operations – Balanced mass flow through entire processing system • Product tracking/diversion – In-line monitoring from beginning-of-run to end-of-run requiring – Proper mechanical access/sampling point design – Control strategy/logic to manage process deviations and interruptions 8

  9. PCMM Assembled POD Processing POD Corridor/Entrance Raw Materials POD POD Technical Space 9

  10. PCM&M POD Layout Raw Materials Tech Corridor/Entrance Space Airlock & Cleanin g cGMP POD Space 10

  11. Current State Batch Process Transfer of Technology Drug Product Current State Quantities Transfer of Technology (dry granulation / roller compaction) Phase IIB Clinical Supplies Experiments <10 kg Engineering Tech Transfer & Process Scale Up Models Phase III Clinical Supplies Process Analytical <100 kg Technology Tech Transfer & Advanced Process Process Scale Up Control Commercial Supplies 100 to 1000 kg │ 11

  12. Future State PCM&M Platform Technology Drug Product Current State Future State Quantities (dry blend / direct compaction) (dry granulation / roller compaction) Phase IIB Clinical Supplies <1 hour <10 kg x Tech Transfer & Process Scale Up time Phase III Clinical Supplies several hours <100 kg x Tech Transfer & time Process Scale Up Commercial Supplies Flexible 100 to 1000 kg time │ 12

  13. An Integrated Approach to a Platform Technology An opportunity to transform the Development to Manufacture Paradigm Integrated System World-class World-class Material Science, Commercial Equipment Formulation & Manufacturing Design Development Practices Process Advanced Analytical Process Technology Control ~500 MM tab/year 24/5 operation, Engineering 30% downtime Models │ 13

  14. PCMM Business Benefits • Same continuous process for product development, clinical trials & commercial production • Eliminates scale-up, minimizes API consumption, reduces tech transfer risk • Production-on-Demand lowers inventory and reduces risk of product expiration • Portable POD minimizes market entry investment with recoverable assets • PAT and APC provide robust, adaptable process control and CPV • Modular technology includes direct compression and wet granulation tablets • Additional unit operations can be added (dry granulation, coating, encapsulation, packaging, etc.) 14

  15. PCMM Videos G-Con Video GEA Video 15

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