4/7/16

1

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Advances in Flexible Manufacturing Infrastructures and Facilities

Maik W. Jornitz, President

G-CON Manufacturing Inc.

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Agenda

Ø Manufacturing Indicators

Ø Changes from Past to Future

• Facilities

• Processes

Ø Possibilities & Innovations

Ø New Infrastructures Implemented

4/7/16

2

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

CurrentSituations

• Patentcliffforsmallmolecules isrealityandaffectslargemolecule industry withcomingbiosimilars

• Regulatoryviewischangingandsupporting agile,efficient andflexible manufacturing platforms

• Global expansionpushtosecureAPIsandcapturelocalmarkets

• Processvolumesbecomelower andmanufacturingrequires tobecomemoreflexible forbetterfacilityandcapacityutilization

• Single-useequipment lacksstilltheflexibility, whenusedintraditional facilitylay-out

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

FutureIndicators

• Agingpopulation ontherisewithfurther needsforcapacitiestoavoidstock-outs

• Risingmiddle classindifferentcountries requirein-country/for countrymanufacturing capacities

• Changingviralandmicrobial diseasesrequire fastresponsepossibilities utilizing newtechnologies anddeploymentmethods

• Regenerative/personalized medicinesrequire specificprocessingsystemsinaccordancewith anypossiblelogistic hurdleandrobustcontainment needs

• Continuous processingminimizesprocessesfurther

4/7/16

3

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

• High CAPEX/higher OPEX

• Long time-to-run

• Product dedicated

• Inflexible/non-scalable

• Extensive qualification needs

• Difficult containment

• Difficult to clone

PastFacilitiesmaynotfitNewNeeds

change

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Past Process ShiftsFrom large scale stainless steel to medium volume single-use to low volume continuous processing

10kL 2kL

De-riskingHigher flexibilityFasterturn-aroundClosed systemsAdvancedPAT

200LClosed systemCapacityflexingProcess stepreductionProcesscontrol

4/7/16

4

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Single-use technology processes create flexibility & speed, but…

…is only as flexible as the surrounding infrastructure !

CourtesyStedim CourtesyG -CONManufacturing

The Benefits of SUT Voided

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

ü Gaining full efficiency from single-use technology

ü Standardization and predesign

ü Movable, re-locatable infrastructures

ü Fast deployable, prefabricated unit operations

ü Clonable in-country/for country facility platforms

ü Platform catalogue choices

ü Processing spaces for new treatment options

ü “Modular” cleanroom and facility designs

Future– Possibilities ?!

4/7/16

5

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Modular Process Unit Operation DesignsDevelopment modular and standardized design components (‘building blocks’), which can then be integrated into a process solution.

LifeCells, standardized roomdesigns,quality testedCourtesy: M+W

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Pre-designed Structures

Courtesy:NNE

• Costandtimereductionthroughout thedesignphases

• Elevationofexperience level

InitialMeeting

ConceptualLayout

ConceptualDes ignDetailedDes ign

Bas ic/SchematicDesign

StartupCommiss ioning

AcceptanceofDrawings

1-2Weeks4-8Weeks

10-12Weeks1- 2Days

Platformcatalogue/redlining

4/7/16

6

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Possible Future Building & Cleanroom Infrastructure

Rapid shell building design & construction, followed by infrastructure implementation

Courtesy of AES & G-CON

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Prefabricated Cleanrooms allow Faster Build

Built in 8 months

Built in 2.5 months

4/7/16

7

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

New Cleanroom Concepts allow Facility Platforms

Prefabricated cleanroom units allow:

• Predesigned unit operations

• Facility platform designs

• Same materials/construction

50,000 egg/day facility platform

2,000L mAb facility platform

Multipurpose/en-user site

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Existing Future Facility Examples

Design

Construction, installation and test runs

Transportation

At

the

man

ufac

ture

r’s

site

Placing the modules

Final installation

Start up Qualification

At t

he c

usto

mer

’s

site

Courtesy: Morten Munk, GE

Built off-siteAssembled on-siteto a facility, example JHL China

4/7/16

8

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Existing Future Facility Examples

Amgen Singapore Site:

• ”Ballroom” layout

• Single-use process technology

• Far reduced foot-print

• New cleanroom classification due to functionally closed processes

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Existing Future Facility Examples

Prefabricated OSD Site Prefabricated Aseptic Filling Site

Courtesy: Pfizer Courtesy: University of Tennessee

4/7/16

9

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

ConclusionØ Current, prevalent facility/process designs become outdated

and strain to meet pressing industry requirements and application needs

Ø Multi-product/multi-purpose facilities become a prevalent request to gain capacity utilization

Ø Facility deployment requires much faster (< 1 year built) and possibly clonable

Ø Single-use process technology supports new demands, but requires the right cleanroom/facility infrastructure to be utilized to the fullest

INTERPHEX | April 26-28, 2016 | JavitsCenter, New York CityPremier Sponsor

Thank You !

mwjornitz@gconbio.com

“The arrogance of success is to think that what you did yesterday will be sufficient for tomorrow”

William Pollard

Maik W. Jornitz, President

G-CON Manufacturing Inc.

https://www.youtub e.co m/w atch?v =DE5 t Cm3 2p_ g