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

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.

Portable, Continuous, Miniature & Modular

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A vision to transform SOD Product Development and Manufacturing

• 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

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PCMM Development Approach

PCMM OSD: A Factory in a POD

Continuous Processing Platform Technology for Solid Oral Dosage Forms HSWG and CDC Skids Pre-fabricated in Belgium … and re-assembled into a grey space warehouse in Groton, CT Integrated into a ‘Portable’ cGMP POD 6 Modules Pre-fabricated in College Station Texas

Building 90 Mock-up

FAT in Belgium Shipped to Groton FAT in Texas Shipped to Groton

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PCMM Videos

G-Con Video GEA Video

PCMM OSD Prototype Processing Equipment

Granule Conditioning Unit Total Elevation ~14.5 ft HSWG Wet Granulation Dryer

Continuous Mixing & Direct Compression ConsiGmaTM WG

CMT Mixer Tablet Press Feeders CMT Mixer Feeders Raw Material Dispensing

PCMM PAT and Product Diversion

Continuous Mixing & Direct Compression ConsiGmaTM WG

PAT 1 (NIR)

Post CMT Potency & Blend Uniformity

PAT 2 (NIR)

Post TSWG Granule Formation

PAT 3 (NIR)

Post Granule Sizing Potency & Granule Uniformity, Moisture

PAT 4 (FBRM)

Post Granule Sizing PSD

PAT 5 (NIR)

Feed Frame Potency & Blend/Granule Uniformity

Diversion 1 Post Fluid Bed Drying Diversion 2 Post Granule Sizing Diversion 3 Tablet Eject Chute

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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

PCMM Assembled POD

Corridor/Entrance POD Raw Materials POD Technical Space Processing POD

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PCM&M POD Layout

Raw Materials cGMP Space Airlock & Cleaning Tech Space Corridor/Entrance POD

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Current State Batch Process

Transfer of Technology

Current State

Tech Transfer & Process Scale Up Tech Transfer & Process Scale Up

100 to 1000 kg <10 kg <100 kg

Commercial Supplies Phase III Clinical Supplies Phase IIB Clinical Supplies

Drug Product Quantities

(dry granulation / roller compaction)

Engineering Models Process Analytical Technology Advanced Process Control Experiments

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Transfer of Technology

Future State PCM&M

Platform Technology

Current State

Tech Transfer & Process Scale Up Tech Transfer & Process Scale Up

x x

100 to 1000 kg <10 kg <100 kg

Commercial Supplies Phase III Clinical Supplies Phase IIB Clinical Supplies

Drug Product Quantities

(dry granulation / roller compaction) │ 12

Future State

(dry blend / direct compaction)

several hours Flexible

time time

<1 hour

time

Process Analytical Technology Engineering Models Advanced Process Control Equipment Design

Integrated System

An Integrated Approach to a Platform Technology

An opportunity to transform the Development to Manufacture Paradigm

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World-class Material Science, Formulation & Development Practices World-class Commercial Manufacturing

~500 MM tab/year 24/5 operation, 30% downtime

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.)

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PCMM Videos

G-Con Video GEA Video