The desire to expand and improve core drug development
capabilities and to meet the strategic need to increase productivity and
efficiently manage a significant increase in clinical trial patient demand led
Merck to embark on an ambitious expansion of its Global Clinical Supplies
Manufacturing, Packaging and Warehouse in Summit, New Jersey.
The integration of the new facility and renovation of an
existing facility on-site has resulted in the project winning the Facility
Integration Award in the Annual Facility of the Year Award program jointly
sponsored by ISPE, INTERPHEX and Pharmaceutical Processing.
A Growing Need
Merck’s Global Clinical Supply groups were located in
Kenilworth and Union, New Jersey with limited space, equipment
capability and scale. The mix of potential compounds in the pipeline indicated
a need for a flexible, multi-product solution to manufacture, fill, package,
and distribute clinical supplies. The elimination of third party organizations
within the clinical manufacturing process was also a priority. The new Global
Clinical Supply facility was designed and built to support drug development in
the stage between discovery and commercialization. There tablets, capsules,
liquids and inhalation products for clinical trials are manufactured along with
the new technologies developed for transfer to commercial production
facilities.
An existing building in Summit, New Jersey,
was selected as the location to support Merck’s drug development activities in
the stage between discovery and commercialization. In order to sustain on-time
delivery of clinical supplies, the new consolidated facility was required to
integrate with other pharmaceutical development functions, achieve compliance
with cGMP and regulatory requirements and address the needs for flexible,
multi-product manufacturing.
Consolidation and Expansion
The project consolidated several cGMP clinical manufacturing,
packaging and warehouse areas within a single state-of-the-art facility in Summit, New
Jersey. An existing decommissioned production
building, S6, was partially demolished, renovated and expanded for improved
clinical manufacturing and development capabilities, increasing productivity
and efficiency, and enabling Merck to better manage a projected significant
increase in clinical trial patient load. The expansion project included
utilization of modular building construction for primary manufacturing
operations and adaptive reuse of a former pharmaceutical warehouse. Speaking to
the benefits of using a modular approach, Michael D. Cirello, Clinical Supplies
Director, GPC Operations said, “The modular construction was very valuable in
achieving the overall success of the project. The major components that led to
the success were:
1) The 3-D model which allowed for a complete review of the
facility prior to any fabrication being initiated. This significantly
contributed to minimal field changes. It also allowed for a very clean layout
in the mechanical spaces.
2) Standardization of building equipment and finishes. This
allowed the user to have a complete knowledge of the type and quality of
building finishes and equipment (HVAC, lighting,) the building would have.
3) Schedule. The flexibility that comes with sequencing the
fabrication of the modules allowed for problems encountered with some of the
equipment deliveries”.
The combination of a modular approach along with adaptive
re-use and renovation helped Merck to achieve the project’s aggressive deadline
with minimal site disruption and maximized utilization of existing
infrastructure. The project also included integration of sustainable design
throughout the design process, culminating in a new, premium efficiency Operational Support Building.
The completed clinical manufacturing facility has the capability to scale-up
and deliver a variety of products simultaneously, including oral solid dosage,
liquid, dry powder inhalation products for clinical manufacturing, filling,
packaging and process development.
The Hybrid Approach
The clinical manufacturing facility was constructed by
Pharmadule modular fabrication in Sweden. Related equipment and
utilities were installed during fabrication and integrated into each module,
thereby reducing time and enabling concurrent engineering project completion in
Sweden.
At the same time in New Jersey,
demolition, excavation and foundation work was ongoing. When the modules
arrived, they were set, assembled and “hooked” up. A critical element of the
project was aligning the new manufacturing modules to the existing structure on
two sides. Commenting on the integration of modular and stick-built
construction, Cirello says, “The biggest limitation was the distance in both time
and miles between the design teams for the modular and stick-built. It was
important to us to have a seamless design so that someone moving from one part
of the facility to the other would not see any appreciable difference. This was
made more difficult because the construction materials and techniques in each
country had some small variations. In order to help overcome this limitation
several methods were employed. First, situating an engineer from the company
performing the "Stick Built" part of the project in the offices of
Pharmadule during the design phase helped us to understand and communicate
issues between the different teams. Second, the use of a Project Information
Management System (PIMS) served as a centralized repository for both the project/design
documentation and provided a forum for initiating, approving and communication
of various 'design decisions' to the project team.”
Modular Details
The structure consisted of 82 modules fabricated in Sweden from
frame to fit-out, including utility hook-ups, to completion in 24 months.
Co-located project teams (3 sites in Sweden/4 sites in the US) consisted
of two design teams, the teams were separated not by functional areas, but by
the different design approaches required. The project teams utilized web-based
Project Information Management System (PIMS) to develop, review, monitor,
control, document and archive key aspects of the design, construction,
qualification,schedule and costs. By utilizing a web-based Project Information
Management System (PIMS), Merck achieved successful project
management/execution to develop, review, monitor, control, document and archive
key aspects of the design, construction, qualification,schedule and costs. The
entire team was able to work within a single system with a single set of data
monitoring project performance in real-time. Early front-end planning, timely
communication and well coordinated sequencing of concurrent, complex and phased
activities between geographically dispersed team members were also key factors
in successful project completion. With the capacity and capability to scale-up
and deliver a variety of products simultaneously, Merck has increased
productivity, technology, compliance and innovation to meet current and future
drug development pipeline needs.
The Details of Flow
As mentioned, one of the project goals was a seamless
integration of new and renovated space. Also important to the facility was the
efficient flow of people. When asked about his favorite features and details of
the facility, Cirello says, “The facility layout provides for the efficient
flow of people, materials and equipment both within and external to the various
integrated business units operating within the facility. This complex
functionality was effectively engineered into an esthetically appealing yet
practical facility. I’m also very happy with the contiguous technical space
providing for ease of access for mechanical service without having to enter the
GMP space. This was consistent with the goal of keeping the majority of
serviceable utilities and process equipment components in the technical space.”
Judges Response
Cirello feels that there were several factors that
contributed to the Facility of the Year Award judges selecting his facility.
“The factors include all the technical challenges and flexibility requirements
associated with the design of a development facility. In this case the primary
driver for the engineering design is not a product with well defined process
requirements, but a series of platform technologies and varying scales that may
be needed based on the development product attributes. In addition, the project
included a combination of selective demolition, new construction, renovation
using both conventional stick built and modular construction technology. In
addition, the project was able to adapt to a significant change in user
requirements, the de-scoping of sterile manufacturing at 90% of BOD, resulting
in only minimal impact to the project timelines.”