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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Current Situation & Future Indicators

The Past & The Current

Different Scenarios with Different Needs

Rethinking the Possibilities

Summary

Agenda

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

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

Global expansion push to secure APIs and capture local markets

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

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

Current Situation

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

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

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

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

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…

Speed• Abbreviated design phases

• Time-to-built/Time-to-run

• Adoption of new technologies

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

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

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 (hospital or cancer center)

Take apart

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

Traditional Hardwall Modular (Container based) 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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Example: MAb ProcessingBuilt off-site 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 ?

Yes(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 ?

The Benefits

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

Acceptance of Drawings

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

Platform catalogue/redlining

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Summary

Current, prevalent facility/process designs become outdated and strain to meet pressing industry requirements and application needs

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

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

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

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

Thank you !mjornitz@gconbio.com

A pessimist sees the difficulty in every opportunity; an

optimist sees the opportunity in every difficulty.

Sir Winston Churchill