INTRODUCTION - PharmOut

Leading Autonomous Cleanroom Designs Confidential Information

INTRODUCTIONModular Cleanrooms

1


Presentation Content

Corporate Overview

Company Activities

POD® Description

POD® Benefits

Alternative Facility Models

Benefit Cases

Conclusion

2


G-CON Manufacturing Introduction

G-CON Manufacturing LLC was founded 2009

and converted to G-CON Manufacturing Inc. in

2014

G-CON is the innovator and market leader of

prefabricated, autonomous cleanroom POD®

designs and 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


Standard POD® Base Design

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8.5’W x 42’L x 11.5’H

(2.59m x 12.80m x 3.51m)230 ft2 Cleanroom Area

(21.7 m2)

12’W x 42’L x 11.5’H


(29.0 m2)

17’W x 42’L x 11.5’H


(43.5 m2)

24’W x 42’L x 11.5’H


(58.0 m2)


POD® Project Range

megaPOD®

36’ x 42’

Other POD® configurations can be engineered to order

miniPOD® CT 8.5’ x 50’, unidirectionalincl. corridor

POD® cluster

miniPOD® CT 12’ x 27’, unidirectional


POD® Standard & Options

Standard POD®

Air handler, compact HVAC

Single commercially available

controller

Fire extinguisher cabinet

Utility supply access

Epoxy flooring & wall

Aluminum windows & doors

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POD® Options

Redundant air handlers

BIBO

Return filters

Redundant controller

Advance controller

software/options

Sprinkler connection

Fire suppression system

Wall panels

Laminate flooring

304 SS window & door system

Interlocking doors

Zero drip quick connects

AH

U 1


Timelines (Standard vs. Project)

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Initial Meeting

Conceptual Layout2D layout

Quote +/- 25%

Conceptual Design3D Layout

Quote +/- 10%

Detailed POD® Design

Basic Design

Startup Commissioning

Acceptance of Drawings

POD Building

FAT

Standard POD®

Project POD®

ship in

ship in


Projects Awarded

Caliber Biotherapeutics (College Station, TX)• Eight 18’ downstream process PODs®

NCTM (College Station, TX)• Multi-product, multi-process bioprocess facility

PaxVax (San Diego, CA)• Special filling suite for vaccines in 24’ POD®

Pfizer PCMM (Groton, CT)• Oral Solid Dosage form, mobile megaPOD® (36’ wide)

Instituto Butantan (Sao Paulo, Brazil)• ISO 5 fill & finish in 12’ wide POD®

Strike Bio (Dallas, TX)• 18’ wide production POD®

University of Tennessee (Memphis, TN)• Three 24’, one 9” wide training & production PODs®

Cell Therapy CMO • 18’ wide processing POD®

Gene Therapy Processing Site• Fourteen various sized PODs®

Just Biotherapeutics (China)• Multiproduct monoclonal antibody process, ten PODs®

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Projects Running

9

Formulation/filling (large & small

scale)

Monoclonal Antibodies (single &

multi-product site, small & large

volume)

Egg-based vaccine platform

Oral Solid Dosage forms (Gen 2)

Cell & Gene therapy

Therapeutic vaccine

Lab infrastructure

• Microbial

• Analytical

• PCR


POD® Technical Features

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Scalable w/o interrupting existing processes

Clonable, as PODs® are always the same

Robust containment due to segregated air

Sanitizable w/ vaporized hydrogen peroxide

Cleanable epoxy inner surface

Robust, light and antimicrobial aluminum structure

Compact and independent duct layout for each POD®

Mobile to be easily placed or relocated, if needed


POD® Economic Features

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Rapid 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

△$1.44B

C $8.64B

Example: Timeline and Value Generation

Assumption: $20M/batch, 3 x batches/week

Leading Autonomous Cleanroom Designs Confidential Information12

Past Facilities - New Needs

• High CAPEX (>$500M)

• Long time-to-run (3-4y)

• Product dedicated

• Inflexible/non-scalable

• Extensive qualification

needs

• Difficult containment

• Difficult to clone

Change

is

Needed


“Modular” Facility Models

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Traditional

Container Built

Stick Built

lead to

“Until now, modular facilities have reproducedtraditional architecture with regard to embeddingutilities piping and HVAC ducts in the interspacebetween the physical module limits and thesuspended ceiling making refurbishment, ifrequired, extremely complicated.

The new approach is to segregate pre-assembledmodules into laboratory and utility modules, whichare designed such that they permit even simplerand faster construction, qualification, validationand maintenance, respectively….”

Alain Pralong, VP GSK, 2013


Changing Facility Sizes and Locations

Change

Traditional PODular Mobile Platforms

Change


“Cloning” of Facilities

Benefits:

• Known entity/process

• Known qualification/validation

• Known filing/audit trail


Benefit Case – Multipurpose

Multi-product processing

Lower cost & complexity of growth

On demand scalability

Possible POD® farms

PODs® can be repurposed, if necessary

Requires only large ‘gray space’

Potential Applications:

Incubator lab space

OSD manufacturing units

Personalized medicine

Leasing transactions

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✔

SPEED

SCALABILITY

CERTAINTY

ECONOMIC

FLEXIBILITY

Buffer Prep

Cryo Storage-70 Storage

Disposables and Dry Storage Quarantine

Reagent QuarantineReleased for Manufacture

WarehouseProduction

Release

CarrCentrifuge

Cold Storage

Sartorius 10 PH/ATFF

Iso 8 Iso 8

Iso 8

AHU1

BIBO

AHU2

BIBO

AHU1

BIBO

AHU2

BIBO

AHU1

BIBO

AHU2

BIBO

AHU1

BIBO

AHU2

BIBO

AHU1

BIBO

AHU2

BIBO

AHU1

BIBO

AHU2

BIBO

AHU1

BIBO

AHU2

BIBO

AHU1

BIBO

AHU2

BIBO

Liquid

Nitrogen

Dewar

4 C Storage

Palletank

Autoclave

LAF

500

500

500

1000

1000

500

Warehouse/QA

Quarantine

Equipment Preparation

Microbial Fermentation

Mammalian Suspension Cell Culture

ChromatographySterile Fill

Medical DeviceAssembly and Packaging

Quality ControlLab

Quality ControlLab

Tissue PreparationLaboratory

Genomics Laboratory

MSProteomics Lab

Pro

du

ctio

n O

ffic

es

Advanced Therapeutics Manufacturing Centre

Proprietary GCON, LLC, 2012

DWG NO REV

Level 11-A-060412 rbh 2.8

SCALE SHEET Ad

RoboticAssay Lab

Mammalian Anchorage Dependent Cell Culture

Patient Specfic Therapeutics

ShippingReceiving

ProcessUtilities

Chillers/boilers/

generatoriCellis Reactor

Re

sear

ch O

ffic

es

Lobby

Iso 8

Up

Up

Conference Room

Up

Up

Conference

Biological Safety

CabinetBench

10 Liter

Cultibag

AKTA Skid

Palletank

Pass Through

50/200

Twin

STR

FlexAct

200

CO2 incubator

Depth FilterLevMix 400

FT-16

Freezing Station

Sartoflow

UF/DF

LevMix 200

LevMix 50

Virus Filtration

FT-16

Filling Station

Transfer Cart

Isolator

500

500

500

500

500

Glass Washer

Sink

500500

1000

1000

SART system

Plant Production

Hig

h P

erfo

rman

ce

Co

mp

uti

ng


Benefit Case – Retrofitting

Use of existing space and utilities

Investment cost minimization

Example:

- Over capacity site (instead of becoming a CMO)

- Obsolete small molecule sites

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PCMM Consortium Project

✔

SPEED

SCALABILITY

CERTAINTY

ECONOMIC

FLEXIBILITY


Benefit Case – Commercialization

Ready in months instead of years

Clonable system of the same design and quality

Repurposable, when new drug product is introduced

Predictable cost & timeline

Example:

- Capacity build-up

- Expansion into other regions

- Multiple sites (in country/for country)

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✔

SPEED

SCALABILITY

CERTAINTY

ECONOMIC

FLEXIBILITY


Benefit Case – Scaling

Scaling without

interruption of existing

processes

Opportunity to delay

time to investment

Unidirectional flow

and corridor

incorporated

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Personalized medicine use

✔

SPEED

SCALABILITY

CERTAINTY

ECONOMIC

FLEXIBILITY


Benefit Case – SUT UnitOp PODs®

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Cell Culture Process

Purification I

Rapid design/deployment

Rapid process flow connectivity

Media Prep

✔

SPEED

SCALABILITY

CERTAINTY

ECONOMIC

FLEXIBILITY


Benefit Case – F/F PODs®

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Possible prequalification

Drop shipment of fill capacity

✔

SPEED

SCALABILITY

CERTAINTY

ECONOMIC

FLEXIBILITY


Benefit Case – labPODs®

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Standardization

Drop shipment of furnished lab space

✔

SPEED

SCALABILITY

CERTAINTY

ECONOMIC

FLEXIBILITY


Conclusion

PODs® Represent a Shift Manufacturing Area Designs and

Implementation:

✓ Autonomous & Agile

✓ Efficient Designs & Process Flows

✓ Faster Time to Run

✓ Repurposing of the Processes or Unit Operations

✓ Rapid Deployment & Mobility

✓ Ease of Scalability to Adjust Capacities

✓ Multi-Product Flexibility

✓ Depreciable as Equipment(5-7 years)

PODs® meet the Demands of the Pharmaceutical Industry for

cost efficient, flexible processing and facility solutions

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Thank you for your attention

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INTRODUCTION - PharmOut