The presentation describes future flexible facility needs, new designs and possibilities, as well as examples

1. Necessities and Possibilities of New
Manufacturing and Facility Designs
PDA Europe 1st Annual Meeting
Berlin, 28-29 June 2016
Maik W. Jornitz
G-CON Manufacturing Inc.

2. 2
 Current Situation & Future Indicators
 The Past & The Current
 Different Scenarios with Different Needs
 Rethinking the Possibilities
 Summary
Agenda

3. 3
 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

4. 4
 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

5. 5
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
Change
is
Needed

6. 6
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

7. 7
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

8. 8
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

9. 9
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

10. 10
Change
Traditional Hardwall Modular (Container based) Assembled
Change
e.g. 10,000L bioreactor transition to multiple 2,000L systems
Scenario: Compression & Diversification
Courtesy Pharmadule

11. 11
Scenario: Multi-product/-tenant
Courtesy FujiFilm Diosynth

12. 12
Example: MAb Processing
Built off-site  Assembled on-site to a repurposable, multi-product
cleanroom infrastructure, example Just Biotherapeutics, China
Courtesy: Just Biotherapeutics, AES, G-CON Manufacturing Inc.

13. 13
Prefabricated OSD Site
Courtesy: Pfizer, Groton, CT, USA
Prefabricated Aseptic Filling Site
Courtesy: University of Tennessee, Memphis, TN, USA
Example: OSD & Aseptic Filling

14. 14
Rethinking – Facility Catalogue ?!
We select Process Equipment from a Catalogue,
can we do the same for Facilities in future ?
(at least cleanroom infrastructures)
Creating Unit
Operations
Courtesy M+W
Standardizing
Platforms
Courtesy G-CON Manufacturing Inc.
Predesigning
Structures
Courtesy NNE Pharmaplan

15. 15
Rethinking – Facility Catalogue ?!
We select Process Equipment from a Catalogue,
can we do the same for Facilities in future ?
Abbreviation of
Design Phases
Known
Qualification Tasks
Set Timelines &
Scopes
Regulatory
Familiarity
Cloning of Training
& Procedures
Initial Meeting
Conceptual Layout
Conceptual Design
Detailed Design
Basic/
Schematic Design
Startup
Commissioning
Acceptance
of Drawings
1-2 Weeks 4-8 Weeks 10-12 Weeks1- 2 Days
Platform catalogue
/redlining

16. 16
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

17. Thank you !
mjornitz@gconbio.com
A pessimist sees the difficulty in every opportunity;
an optimist sees the opportunity in every difficulty.
Sir Winston Churchill