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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 [email protected]
A pessimist sees the difficulty in every opportunity; an
optimist sees the opportunity in every difficulty.
Sir Winston Churchill