PCMM Portable, Continuous, Miniature and Modular Technology Rick - PowerPoint PPT Presentation

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 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

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

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

PCMM Videos G-Con Video GEA Video 5

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

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

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

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

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

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

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

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

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

PCMM Videos G-Con Video GEA Video 15