G-CON

Cleanroom

POD® Design

Solutions & Benefits

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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

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G-CON Company IntroductionG-CON 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 5600m2 manufacturing and design facility, to double end of 2018.

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Standard POD® Base Design8.5’W x 50’L x 11.5’H

(2.59m x 15.24m x 3.51m)289 ft2 Cleanroom Area

(26.9 m2)

12’W x 50’L x 11.5’H

(3.65m x 15.24m x 3.51m)408 ft2 Cleanroom Area

(37.9 m2)

17’W x 50’L x 11.5’H

(5.18m x 15.24m x 3.51m)578 ft2 Cleanroom Area

(53.7 m2)

24’W x 50’L x 11.5’H

(7.32m x 15.24m x 3.51m)816 ft2 Cleanroom Area

(75.8 m2)

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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

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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.

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POD Pfizer Videohttps://www.youtube.com/watch?v=Xys-

L9aMm6k&sns=em

GEA Pharma Systems, G-CON 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.

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POD® Economic FeaturesRapid deployment w/o sequential construction, faster time to run

Capacity flexing (up and down)

Repurposable asset

Cloning sites means abbreviated timelines

Leasing of PODs® is available

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

0 5 10 15 20

POD

Modular

Stick-built

Months

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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

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Aseptic Fill FinishPOD 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

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OSD Continuous Manufacturing

PCMM

Flexible and Configurable Design

• Tablets and/or Capsules

• Direct Compression and/or Wet

Granulation

• Pilot through Commercial Scale

(up to 500 MM tab/year)

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

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Personalised Therapies

miniPOD® CT

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

Easily redeployed to new or final

location if needed

Voids the decision need of

centralised versus decentralised

locations

Rapidly deployable in few months

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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 pre-engineered building (e.g. Butler)

Segregation of areas eliminates contamination shut-down

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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

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2000L mAB Facility Platform to ChinaBuilt off-site Assembled on-site to a repurposable, multi-product

cleanroom infrastructure, example Just Biotherapeutics, China

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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

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