To learn just how to get iCON ready, we sat down for a Q&A session with the Tour Leaders: Erich Bozenhardt, Process Manager, and Tom Piombino, Senior Director, Process Architecture, both of IPS, and Dennis Powers, Director of Sales Engineering, G-CON Manufacturing
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How to Get iCON Ready
1. INTERPHEX 2018 IPS TECHNOLOGIES TOUR GUIDE 17
ARE YOU iCON™ READY?
Q. What factors prompted the
move toward development of
iCON?
A. iCON is a forward-looking
response to an industry that
demands collaboration and
innovation to assist operating
companies in getting products
to patients. IPS and G-CON
are consistently asked by
their clients to deliver pre-
engineered turnkey facility
solutions that can be rapidly
deployed, but also have
flexibility in their design and
capability to adapt to changing
market needs. Both the pre-
engineered and flexibility
factors pull in technology,
which makes perfect sense.
Our companies have a
common vision for the
future of manufacturing.
Collaborating with the right
partners, each of which brings
their own complementary
products and expertise, is
the best approach. iCON is
not the first turnkey facility
solution to the market, but
we feel strongly that it is the
most sustainable one and
brings significant value to
drug manufacturers in ways
that the other solutions of the
past have not.
Q. How specifically can it
introduce new efficiencies
and cost savings within the
typical pharma facility and
environment? Are there any
projected ROI metrics?
A. Because iCON is based on
a pre-engineered design, the
client can realize both cost-
and time-savings during the
engineering design phase.
The closer they stay to the
standard design, the lower
the cost and the shorter the
timeframe. Since both the
cleanroom PODs and Butler
Buildings are pre-fabricated
in a factory, construction
activities are taking place in
parallel rather than sequentially
allowing the project timelines
to be further compressed. The
onsite installation, assembly,
and start-up can be performed
much faster than a traditional
facility construction project,
allowing for validation
activities to start sooner. The
biggest impact to ROI for a
client is typically the shorter
timeframe for production start-
up and revenue generation.
Additionally, the ability to
easily scale up or modify their
operation within the iCON
facility to adjust to changing
iCON™ – The Turnkey Facility
of the Future Here Today.
Are you iCON™ Ready?
To learn just how to get iCON ready, we sat down for a Q&A session
with the Tour Leaders: Erich Bozenhardt, Process Manager, and Tom
Piombino, Senior Director, Process Architecture, both of IPS, and
Dennis Powers, Director of Sales Engineering, G-CON Manufacturing.
Erich Bozenhardt,
Process Manager,
IPS
Tom Piombino,
Senior Director,
Process Architecture,
IPS
Dennis Powers,
Director of Sales
Engineering,
G-CON Manufacturing
2. 18 IPS TECHNOLOGIES TOUR GUIDE INTERPHEX 2018
ARE YOU iCON™ READY?
market needs also can provide
significant value over pure
purpose built facilities.
Q. Is it a technology or service
that can be implemented
within existing legacy
systems?
A. iCON is intended to be either
a greenfield or brownfield
turnkey solution. It also can
be implemented within legacy
structures. For example, we
are working on a cell therapy
project within an existing space
that was abandoned. The
modules were able to integrate
within the existing structure
and leverage existing central
utilities.
As a first step, an
Inceptioneering study can be
conducted to determine the
clients’ project requirements
and assess their current
available facilities, systems,
and capabilities. Based on the
outcome of the study, alignment
with the iCON platform
design can be determined and
recommendations made to the
client. In some instances, only
certain elements of the iCON
platform may be appropriate
rather than the comprehensive
iCON facility solution. For
these cases, the iCON team
will provide a recommendation
for the products and services
required to meet the
client needs.
Q. What is the most unique
characteristic of iCON?
A. There are many
characteristics that distinguish
iCON from its modular
competitors and from
more traditional stick-build
projects. To highlight one,
our introduction of “Hybrid
Modularization” is high on
the uniqueness list. When
you look at the many facets
of modular in the current
construction market, you’ll
find companies that really
specialize in certain areas, but
will do others as needed. iCON
really strives to combine the
efficiency of those specialties
and balance it with the use of
regional craft labor in a hybrid
approach. IPS and G-CON
exist as thriving companies
without iCON, but when we
bring together our specialties
in EPCMV and mobile modular
cleanroom fabrication, things
get really interesting. What
client wouldn’t want to
pool the most creative and
efficient companies in the
world together to deliver
their project?
Q. How long did it take to
design and implement iCON?
Is it customizable?
A. iCON isn’t one thing so to
answer the question around
design duration, we’d have
to say that it will never be
done. We are adapting the
initial iCON platform for
mAb processing to cGMP
applications like Cell/Gene
Therapies, Continuous
Solid Dosage, Isolated Fill
Finish, Weigh/Dispense,
Solution Preparation, Wash
Rooms, etc. Each project
brings another product to
market and as the world
continues to adapt to iCON
innovation, we expect the
term “customization” will give
way to our organically grown
term, “optionalization,” which
really conveys a philosophy of
taking something off the iCON
shelf and offering standard
options.
Q. Are new iCON-related
services under development
for introduction over the next
few years?
A. Yes is not a strong enough
word to answer this question.
Great minds produce great
ideas, which in turn fuel new
and creative implementation
strategies. We have clients
call us frequently asking if
iCON can fit their application
and/or have already come to
a conclusion that it will and
have ideas on how. It often
feels a bit like Linux where
the people who want to use it
contribute as an open source,
minus the free part of course.
iCON as a mobile modular
delivery product has unlimited
possibilities and we have two
or three more products being
introduced in 2018. iCON as
a service also is growing and
as we look to the future, our
vision is to serialize our project
delivery process.
iCON™ is intended to be either
a greenfield or brownfield
turnkey solution.
3. INTERPHEX 2018 IPS TECHNOLOGIES TOUR GUIDE 19
ARE YOU iCON™ READY?
AES Clean Technology
www.aesclean.com | Booth #1642
AES Pharma Wall and Ceiling
Within the iCON™ delivery solution, the AES
Pharma wall and ceiling system provides modular
component support. AES elements are rapidly
deployable in the mobile and modular facility
platform. Our modular system is FM Global and
ICC approved. The Pharma wall includes: UL
raceways and has integrated doors, windows,
coving, and other flush components. Surfaces
are compatible with H202 and other stringent
decontamination protocols. PVC cold welded
panel seams eliminates caulk and provides a
monolithic finish. AES Modular system reduces
the project schedule and ensures compliance in
every phase of the project lifecycle. We deliver
beautiful cleanrooms as the end-result.
Butler Manufacturing™
www.butlermfg.com
G-CON Manufacturing, Inc.
www.gconbio.com | Booth #2429
The Turnkey Facility of the Future, Here Today
In September 2017, G-CON Manufacturing and
Integrated Project Services, LLC (IPS), introduced
the biopharmaceutical industry to iCON™, a turnkey
modular facility platform solution for biomanufac-
turing. The iCON™ facility is unique in many ways;
most importantly though, it can be established in
less than a year and can be transformed from the
development stage facility to clinical and commer-
cial phases without interrupting existing processes.
IPS-Integrated Project Services, LLC
www.ipsdb.com | Booth #2132
IPS’ Integrated EPCMV Delivery:
Minimizing Business Risk and Reducing
Overall Schedule and Costs
IPS is the pioneer in the application of single-
source integrated EPCMV project delivery
for technically complex facilities. We have
developed, refined, and implemented a lean
delivery model that addresses the entire project
life cycle, from inception through validation to
project completion. Working in a collaborative
environment, we analyze and challenge every
step of the project delivery cycle and apply
unique ideas and solutions to eliminate wasteful
and redundant processes. Our application of
lean project delivery strategies are driven by
design quality and effective control of costs
and schedule, offering clients the predictable
outcomes they come to expect while minimizing
risk, reducing the duration from decision to
delivery, and streamlining efficiencies.
MilliporeSigma
www.emdmillipore.com/end-to-end
Booth #2841
End-to-End Turnkey Modular MAb
Manufacturing Platform
BioReliance® End-to-End Solutions encompasses
service and support for both emerging biotech
and major biopharmaceutical companies that
seek to accelerate drug development—from early
clinical to commercial production. We operate our
own in-house bioproduction facilities and convey
our expertise to clients as they progress on their
drug development journey, with an emphasis on
single-use technologies and high-performance
upstream and downstream systems. Together
with iCON™, we provide turnkey solutions
for the deployment of fast and efficient MAb
bioproduction facilities.
TECH HIGHLIGHTS FROM PARTICIPATING TOUR VENDORS