G-Con Manufacturing - POD Benefits - 10-16

Leading Autonomous Cleanroom Designs

THE POD® BENEFITflexibility repurposibility mobility

1


POD® Features

2

• Reliable reproducibility and delivery timelines

• Scalable w/o interrupting existing processes

• Rapid deployment w/o sequential construction

• Clonable as PODs® are always the same

• Sanitizable w/ vaporized hydrogenperoxide

• Cleanable epoxy inner surface

• Robust, light and antimicrobial aluminum structure

• Energy efficient due to efficient, leak free duct layout

• Mobile to be easily placed or relocated, if needed

• Repurposable instead of being a lost asset

• Depreciated as equipment (5-7 versus 20-30 years)

0 5 10 15 20

POD

Modular

Stick-built

Months


Modularity versus Podularity

3

Traditional Hardwall

Offsite Built Modular

Modular - 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, if required,extremely complicated.

The new approach is to segregate pre-assembledmodules into laboratory and utility modules, whichare designed such that they permit even simpler andfaster construction, qualification, validation andmaintenance, respectively….”Alain Pralong, VP GSK


Cost to Consider PODs® vs Traditional

4

Value Block Items to be analyzedCAPEX • Design costs

• Engineering costs• Supervision• Insurance• Change Orders• Floor space requirement• Laydown area

OPEX • Energy consumption due to pressure losses• Energy consumption due to temperature• Maintenance• Repairs• Shut-down

NPV • Time to Run


Comparison PODs® vs Traditional

5

Independent cost and time-to-built comparison performed by

Compared application: 2 x 2,000L monoclonal antibody process

Process technology: Single-use process technology

Compared cleanroom infrastructure: Stick-built, Modular-built, POD-built

Compared shell building: 45,000 sq.ft appropriate for the cleanroom infrastructure



6

Total Cost



7

Time-to-Built


Time-to-Run

88

Parallel construction and rapidly combining deliverables abbreviate the total time-to-run by multiple months

0 5 10 15 20 25

POD

Modular

Stick-built

FacilityOperational MechanicalCompletion

Months

Benefit à Delaying the CAPEX decision or avoiding contracting out


Time-to-Run in Value

99

Assumption: $5 Million/Batch, 3 Batches/Week Production Schedule

0 100 200 300 400 500 600 700

11

12

13

14

15

16

17

18

19

20

21

22

$Millions

Mon

ths

ValueCreationDueToFasterTime-To-Run

Stick-built Modular POD

PODvs.Modularincr.revenue: $4.3BPODvs.Stick-builtincr.revenue: $4.6BModularvs.Stick-builtincr.revenue: $0.3B


Cloning or Reproduction Benefits

10

Abbreviation ofDesign Phases

Known Qualification Tasks

Set Timelines & Scopes

Regulatory Familiarity

Cloning of Training & Procedures

Initial Meeting

Conceptual Layout

Conceptual DesignDetailed Design

Basic/Schematic Design

Startup Commissioning

Acceptanceof Drawings

1-2 Weeks 4-8 Weeks 10-12 Weeks1- 2 Days

Platform catalogue/redlining


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

Elimination of any contamination issues (e.g. mold)

Relocatable when the cleanroom infrastructure is needed elsewhere or the current location becomes less ideal

11


THE POD® BENEFITfast reproducible reliable

12

6161 Imperial Loop, College Station, TX 77845 Telephone 855.751.GCON

Mailing Address P.O. Box 15922, College Station, TX 77841 e-mail [email protected]

Documents

G-Con Manufacturing - POD Benefits - 10-16