Cleanroom POD Design Solutions & Benefits G-CON

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Rhoda Walsh
5 years ago
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1 Cleanroom POD Design Solutions & Benefits

2 Agenda Company Introduction POD Design POD Technical Features Industry Trends & PODS Pfizer Video of installation POD Economic Benefits Applications From Lab to full scale production Conclusion

Company Introduction Manufacturing LLC, founded 2009

technologies Highly experienced management team:

Regulatory Requirements Process/Personnel/Material/Waste

Product Management Headquartered in College Station, TX

3 Company Introduction Manufacturing LLC, founded 2009 innovator of prefabricated, autonomous cleanroom POD technologies Highly experienced management team: Design/Engineering/Cleanroom Construction Quality & Regulatory Requirements Process/Personnel/Material/Waste Flows GMP/GDP/GLP/GAMP Requirements Project, Process & Product Management Headquartered in College Station, TX Current Capacity ~60 PODs a year at a 5600m 2 manufacturing and design facility, to double end of 2018.

5 H (7.32m x 15.24m x 3.51m) 289 ft 2 Cleanroom Area (26.

4 Standard POD Base Design 8.5 W x 50 L x 11.5 H (2.59m x 15.24m x 3.51m) 12 W x 50 L x 11.5 H (3.65m x 15.24m x 3.51m) 17 W x 50 L x 11.5 H (5.18m x 15.24m x 3.51m) 24 W x 50 L x 11.5 H (7.32m x 15.24m x 3.51m) 289 ft 2 Cleanroom Area (26.9 m 2 ) 408 ft 2 Cleanroom Area (37.9 m 2 ) 578 ft 2 Cleanroom Area (53.7 m 2 ) 816 ft 2 Cleanroom Area (75.8 m 2 )

Robust containment due to segregated air Sanitizable w/ vaporized hydrogen

5 POD Technical Features Dedicated HVAC System per POD Scalable w/o interrupting existing processes Clonable, as PODs are always the same Robust containment due to segregated air Sanitizable w/ vaporized hydrogen peroxide Compact layout for each POD Mobile to be easily placed or relocated, if needed

Continuous manufacturing. Biopharma CMO growth averaged 15% last 3 years and will continue.

6 Industry Trends & PODS Flexible manufacturing solutions and Single-Use Technology continues to grow. Personalised medicine growth e.g. Cell Therapy and recent Novartis approval for CAR-T CTL019. Continuous manufacturing. Biopharma CMO growth averaged 15% last 3 years and will continue. Reduced footprints due to process intensification e.g. 10kL Reactors to 2kL.

7 POD Pfizer Video L9aMm6k&sns=em GEA Pharma Systems, and Pfizer collaborate to develop innovative, next generation processing technologies for oral solid dosage (OSD) forms. Designed to address the rapidly changing requirements of pharmaceutical development and manufacturing, PCMM (Portable Continuous Miniature and Modular) manufacturing aims to meet the industry s needs for continuous processing in a flexible, self-contained manufacturing space. PCMM comprises a system that integrates a small footprint, continuous processing equipment, smart control systems and PODs (portable, self-contained GMP modules) to process API powders and inactive ingredients into to bulk tablets.

POD Economic Features Rapid deployment w/o sequential construction, faster time to run Capacity flexing (up and down) Stick-built Repurposable asset Cloning sites means abbreviated timelines Leasing

8 POD Economic Features Rapid deployment w/o sequential construction, faster time to run Capacity flexing (up and down) Stick-built Repurposable asset Cloning sites means abbreviated timelines Leasing of PODs is available Modular POD Months Depreciated as equipment (5-7 years) Lower total cost due to off-site built Energy efficient due to compact, leak free ductwork Segregation allows the facility to continue when one POD is down

repurposed or redeployed as needed for manufacturing or validation support activities

9 Laboratory Space Can be designed for microbial, analytical, assay, viral applications, etc. Flexible design allows for easy expansion of new and existing lab infrastructure Easily repurposed or redeployed as needed for manufacturing or validation support activities Integration of lab equipment and casework at factory Designed for range of environmental and biosafety requirements

Aseptic Fill Finish POD design integrated with technologies from leading Fill

Syringes, Cartridge formats Pre-sterilized components Lyophilizer can be

drug shortages Can be integrated with complete Drug Product Facility including

10 Aseptic Fill Finish POD design integrated with technologies from leading Fill Line and Isolator Manufacturers Flexible design and configurations Vials, Syringes, Cartridge formats Pre-sterilized components Lyophilizer can be integrated Rapid design and deployment to respond to market needs and address drug shortages Can be integrated with complete Drug Product Facility including formulation, weigh/dispense, component prep, etc. Easily redeployed to new site if needed

OSD Continuous Manufacturing Flexible and Configurable Design Tablets and/or Capsules Direct Compression and/or Wet Granulation Pilot through Commercial Scale (up to 500 MM tab/year) PCMM Material

11 OSD Continuous Manufacturing Flexible and Configurable Design Tablets and/or Capsules Direct Compression and/or Wet Granulation Pilot through Commercial Scale (up to 500 MM tab/year) PCMM Material Handling Capability OEB 1-4 Products API Dispensing Room Multiple container formats (Drum, IBC, FIBC) Washing and Storage Areas Integrated Technical Space Dust Collection Vacuum Transfer Systems Process Air Handlers

unidirectional flow Capable of multi-batch processing minipod CT Easily redeployed to new or final

12 Personalised Therapies POD designs for Cell Therapy, Gene Therapy and Autologous Vaccine manufacturing Designed for scaling without interruption to existing operations Integrated airlocks and corridors with unidirectional flow Capable of multi-batch processing minipod CT Easily redeployed to new or final location if needed Voids the decision need of centralised versus decentralised locations Rapidly deployable in few months

areas including laboratories, equipment wash areas, and decontamination Designed for deployment into

13 Vaccine Facility Platforms Facility designed for processing 50,000 eggs per day Multi-valent campaign manufacturing capability Designed with integrated Rame- Hart egg processing equipment Integrated support areas including laboratories, equipment wash areas, and decontamination Designed for deployment into existing structure or in new preengineered building (e.g. Butler) Segregation of areas eliminates contamination shut-down

space or with new Butler building constructed in parallel to PODs Design integrated with clients

14 2000L mab Facility Platform Two 2,000L Scale Upstream Trains and Downstream Purification Train for Bulk Drug Substance manufacturing Construction timeline 10 months Can be integrated into existing space or with new Butler building constructed in parallel to PODs Design integrated with clients preferred single use process equipment and technologies Capable for multi-product operations Clonable

15 2000L mab Facility Platform to China Built off-site Assembled on-site to a repurposable, multi-product cleanroom infrastructure, example Just Biotherapeutics, China

16 Conclusion PODs represent a value creation, which goes beyond cost/sq.ft, but requires to be reviewed at total cost ownership (TCO) Besides faster time-to-run, the POD infrastructure has following additional benefits: Scalability without interruption of existing manufacturing processes Repurposability for multiple product lifecycles Depreciation as equipment (5-7 years) Robust containment, which can be sanitized with VHP Prequalification Rapid deployment 16

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