Leading Autonomous Cleanroom Designs Confidential Information
Presentation Content
Corporate Overview
Company Activities
POD® Description
POD® Benefits
Alternative Facility Models
Benefit Cases
Conclusion
2
Leading Autonomous Cleanroom Designs Confidential Information
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
Leading Autonomous Cleanroom Designs Confidential Information
Standard POD® Base Design
4
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
(3.65m x 12.80m x 3.51m)312 ft2 Cleanroom Area
(29.0 m2)
17’W x 42’L x 11.5’H
(5.18m x 12.80m x 3.51m)460 ft2 Cleanroom Area
(43.5 m2)
24’W x 42’L x 11.5’H
(7.32m x 12.80m x 3.51m)624 ft2 Cleanroom Area
(58.0 m2)
Leading Autonomous Cleanroom Designs Confidential Information
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
Leading Autonomous Cleanroom Designs Confidential Information
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
6
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
Leading Autonomous Cleanroom Designs Confidential Information
Timelines (Standard vs. Project)
7
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
Leading Autonomous Cleanroom Designs Confidential Information
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®
8
Leading Autonomous Cleanroom Designs Confidential Information
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
Leading Autonomous Cleanroom Designs Confidential Information
POD® Technical Features
10
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
Leading Autonomous Cleanroom Designs Confidential Information
POD® Economic Features
11
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
Leading Autonomous Cleanroom Designs Confidential Information
“Modular” Facility Models
13
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
Leading Autonomous Cleanroom Designs Confidential Information
Changing Facility Sizes and Locations
Change
Traditional PODular Mobile Platforms
Change
Leading Autonomous Cleanroom Designs Confidential Information
“Cloning” of Facilities
Benefits:
• Known entity/process
• Known qualification/validation
• Known filing/audit trail
Leading Autonomous Cleanroom Designs Confidential Information
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
16
✔
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
Leading Autonomous Cleanroom Designs Confidential Information
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
18
PCMM Consortium Project
✔
SPEED
SCALABILITY
CERTAINTY
ECONOMIC
FLEXIBILITY
Leading Autonomous Cleanroom Designs Confidential Information
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)
19
✔
SPEED
SCALABILITY
CERTAINTY
ECONOMIC
FLEXIBILITY
Leading Autonomous Cleanroom Designs Confidential Information
Benefit Case – Scaling
Scaling without
interruption of existing
processes
Opportunity to delay
time to investment
Unidirectional flow
and corridor
incorporated
22
Personalized medicine use
✔
SPEED
SCALABILITY
CERTAINTY
ECONOMIC
FLEXIBILITY
Leading Autonomous Cleanroom Designs Confidential Information
Benefit Case – SUT UnitOp PODs®
23
Cell Culture Process
Purification I
Rapid design/deployment
Rapid process flow connectivity
Media Prep
✔
SPEED
SCALABILITY
CERTAINTY
ECONOMIC
FLEXIBILITY
Leading Autonomous Cleanroom Designs Confidential Information
Benefit Case – F/F PODs®
24
Rapid design/deployment
Possible prequalification
Drop shipment of fill capacity
✔
SPEED
SCALABILITY
CERTAINTY
ECONOMIC
FLEXIBILITY
Leading Autonomous Cleanroom Designs Confidential Information
Benefit Case – labPODs®
25
Rapid design/deployment
Standardization
Drop shipment of furnished lab space
✔
SPEED
SCALABILITY
CERTAINTY
ECONOMIC
FLEXIBILITY
Leading Autonomous Cleanroom Designs Confidential Information
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
26
Top Related