Necessities and Possibilities of New Manufacturing and Facility Designs

PDA Europe 1st Annual MeetingBerlin, 28-29 June 2016

Maik W. JornitzG-CON Manufacturing Inc.

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Ø Current Situation & Future Indicators

Ø The Past & The Current

Ø Different Scenarios with Different Needs

Ø Rethinking the Possibilities

Ø Summary

Agenda

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v Patent cliff for small molecules is reality and affects large molecule industry with coming biosimilars

v Regulatory view is changing and supporting agile, efficient and flexible manufacturing platforms

v Global expansion push to secure APIs and capture local markets

v Process volumes become lower and manufacturing requires to become more flexible for better facility and capacity utilization

v Single-use equipment lacks still the flexibility, when used in traditional facility lay-out

Current Situation

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v Aging population on the rise with further needs for capacities to avoid stock-outs/drug shortage

v Rising middle class in different countries require in-country/for country manufacturing capacities

v Changing viral and microbial diseases require fast response possibilities utilizing new technologies and deployment methods

v Regenerative/personalized medicines require specific processing systems in accordance with any possible logistic hurdle and robust containment needs

v Continuous processing minimizes processes further

Future Indicators

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Past Facilities may not fit New Needs

• High CAPEX (>$500M)• Long time-to-run (3-4y)• Product dedicated• Inflexible/non-scalable• Extensive qualification

needs• Difficult containment• Difficult to clone

Changeis

Needed

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Some New Concept may be Lacking

“Until now, modular facilities have reproduced traditional architecture with regard to embedding utilities piping and HVAC ducts in the interspace between the physical module limits and the suspended ceiling making refurbishment, if required, extremely complicated.

The new approach is to segregate pre-assembled modules into laboratory and utility modules, which are designed such that they permit even simpler and faster construction, qualification, validation and maintenance, respectively….” Alan Pralong (2013)

FLEXIBILITY is KEY

Brick & Mortar Modular Predesigned

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The Future requires…

ü Speed• Abbreviated design phases

• Time-to-built/Time-to-run

• Adoption of new technologies

ü Agility • Scaling up- and down w/o interruption of existing processes

• Rapidly deployed in multiple locations (in-country/for country)

ü Efficiency• Higher yield per footprint

• Faster turn-around/set-up time

• Multi-product runs (parallel)

• Infrastructures for multi-purpose use

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Scenario: Precision Medicine

The question of centralized or decentralized (hospital, cancer center, local based, logistics hub, airport location) is still debated (needle to needle logistics for example)

Centralized(hub)

Decentralized(hospitalorcancercenter)

Takeapart

Re-assemble

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

…is only as flexible as the surrounding infrastructure !

Courtesy Stedim

Scenario: SUT Implementation

Courtesy G-CON Manufacturing

Courtesy GE

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Change

TraditionalHardwall Modular (Containerbased) Assembled

Change

e.g. 10,000L bioreactor transition to multiple 2,000L systems

Scenario: Compression & Diversification

Courtesy Pharmadule

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Scenario: Multi-product/-tenant

Courtesy FujiFilm Diosynth

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Courtesy: GE

Built off-site à Assembled on-site to a facility, example JHL China

Example: MAb Processing

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Example: MAb ProcessingBuilt off-site à Assembled on-site to a repurposable, multi-product cleanroom infrastructure, example Just Biotherapeutics, China

Courtesy: Just Biotherapeutics, AES, G-CON Manufacturing Inc.

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Prefabricated OSD Site

Courtesy: Pfizer, Groton, CT, USA

Prefabricated Aseptic Filling Site

Courtesy: University of Tennessee, Memphis, TN, USA

Example: OSD & Aseptic Filling

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Rethinking – Facility Catalogue ?!

We select Process Equipment from a Catalogue, can we do the same for Facilities in future ?

(at least cleanroom infrastructures)

Creating UnitOperations

Courtesy M+W

StandardizingPlatforms

Courtesy G-CON Manufacturing Inc.

PredesigningStructures

Courtesy NNE Pharmaplan

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Rethinking – Facility Catalogue ?!

We select Process Equipment from a Catalogue, can we do the same for Facilities in future ?

Abbreviation ofDesign Phases

Known Qualification Tasks

Set Timelines & Scopes

Regulatory Familiarity

Cloning of Training & Procedures

InitialMeeting

Conceptual Layout

Conceptual DesignDetailed Design

Basic/Schematic Design

StartupCommissioning

AcceptanceofDrawings

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

Platform catalogue/redlining

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Summary

Ø Current, prevalent facility/process designs become outdated and strain to meet pressing industry requirements and application needs

Ø Facilities require to adopt mobility in case of processing and location decision delays or being repurposable, instead of “mothballed”

Ø ”Platinum standard” aseptic processing requires to be accommodated within robust and strict containment options

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

Thank you !mjornitz@gconbio.com

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

William Pollard