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
FAT in Texas
Shipped to Groton
… and re-assembled into a grey
space warehouse in Groton, CT
PCMM Videos
G-Con Video
GEA Video
5
PCMM OSD Prototype Processing Equipment
Feeders
CMT
Mixer
CMT
Mixer
Feeders
Granule
Conditioning
Unit
HSWG Wet
Granulation
Tablet
Press
Dryer
Continuous Mixing
& Direct Compression
ConsiGmaTM WG
Raw
Material
Dispensing
Total
Elevation
~14.5 ft
PCMM PAT and Product Diversion
Diversion 1
Post Fluid Bed
Drying
PAT 1 (NIR)
Post CMT
Potency & Blend
Uniformity
PAT 2 (NIR)
Post TSWG
Granule Formation
PAT 3 (NIR)
PAT 5 (NIR)
Post Granule Sizing
Potency & Granule
Uniformity, Moisture
Feed Frame
Potency & Blend/Granule
Uniformity
Diversion
3 Mixing
Continuous
Tablet
Eject Compression
Chute
& Direct
PAT 4 (FBRM)
Post Granule Sizing
PSD
Diversion 2
Post Granule TM
ConsiGma WG
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
Corridor/Entrance
POD
Processing
POD
Raw Materials
POD
Technical
Space
9
PCM&M POD Layout
Raw
Materials
Corridor/Entrance
POD
cGMP
Space
Airlock &
Cleaning
Tech
Space
10
Current State Batch Process
Transfer of Technology
Current State
(dry granulation / roller compaction)
Drug Product
Quantities
Phase IIB Clinical Supplies
<10 kg
Transfer of Technology
Experiments
Engineering
Models
Tech Transfer &
Process Scale Up
Phase III Clinical Supplies
<100 kg
Tech Transfer &
Process Scale Up
Process Analytical
Technology
Advanced Process
Control
Commercial Supplies
100 to
1000 kg
│ 11
Future State PCM&M
Platform Technology
Current State
(dry granulation / roller compaction)
Drug Product
Quantities
Future State
(dry blend / direct compaction)
Phase IIB Clinical Supplies
x
<1 hour
<10 kg
Tech Transfer &
Process Scale Up
time
Phase III Clinical Supplies
x
several
hours
<100 kg
Tech Transfer &
Process Scale Up
time
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
Material Science,
Formulation &
Development
Practices
Equipment
Design
Advanced
Process
Control
Process
Analytical
Technology
Engineering
Models
│ 13
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.)
14
PCMM Videos
G-Con Video
GEA Video
15