Solution Summary
Challenge

ImClone Systems Incorporated, (ImClone Systems) recently expanded its bulk
manufacturing facility in Branchburg, NJ. Scaling up current environmental andutility monitoring operations would require the addition of many new technicalpersonnel.

Solution

ImClone Systems implemented MODA-EM™, a mobile computing platform
to automate the collection, management, and reporting of environmental
and quality control monitoring information, which increased the productivity of
its current staff.
The new workflow reduced, and in most cases, eliminated paper and prevented
documentation errors.

Business Value By improving the productivity of its QC Analysts, ImClone Systems reduced thehiring requirements to support the expanded facility – a significant cost savings.
In addition, the improved accuracy of the new workflow gives ImClone Systems
a more robust QC operation.

Product Demand Drives Growth
ImClone Systems Incorporated (Nasdaq: IMCL), was founded in 1984, with its first laboratory opening in1986 in New York City. The company originally focused on immunology-based diagnostics andinfectious disease vaccines. In the early nineties, the company shifted its focus to the developmentof innovative, biologic compounds in the area of oncology.

Case Study

ImClone Systems, Incorporated
Improves Environmental and Utility Monitoring
Efficiency and Accuracy with MODA-EM™

Case Study

Leveraging the advances made in the fields of molecular biology, oncology, genomics andantibody engineering, ImClone Systems has since built a novel pipeline of product candidates
to address specific genetic mechanisms involved in cancer growth and development.
ERBITUX®, ImClone Systems’ flagship product, was approved in 2004 for treatment ofcolorectal cancer and in 2006 for treatment of head and neck cancer. ERBITUX is a monoclonal
antibody designed to inhibit the function of a molecular structure expressed on the surfaceof normal and tumor cells called the epidermal growth factor receptor. This receptor is partof a signaling pathway that is linked to the growth and development of many human cancers,
including those of the head and neck, colon, and rectum.
ImClone Systems’ Branchburg, NJ site is the primary bulk manufacturing facility for
ERBITUX. Commissioned in 2001, the Branchburg site has since grown from two to sevenbuildings to meet the increased demand for the product.

Business Impact
ERBITUX is classified as a parenteral drug – one that is administered by injecting it into thepatient. Like many parenterals, ERBITUX can not be terminally sterilized – a process thatkills potentially contaminating microorganisms using heat or radiation. Instead, ERBITUX is
manufactured aseptically – a highly controlled process that minimizes exposure of theproduct to potential contaminants. Aseptic manufacturing requires constant monitoring of
the environment to ensure that potential contaminants are kept below prescribed levels.
Routine sampling and testing of the environment (air, surfaces, equipment, personnel,water, and compressed gases) for potential contaminants is required by the Federal
regulations that govern the manufacture of products like ERBITUX.
When the Branchburg facility expanded, the existing QC staff was required to work overtime
and additional hiring was planned to handle the increased workload. In addition, thepaperwork involved with the environmental and utility monitoring regimen was consuming
too much of the analysts’ time. “The process required a lot of coordination,” stated Kimberly
McFarland, ImClone Systems’ Associate Director of Quality Control Microbiology. “Criticalinformation was recorded on paper by the QC Analysts for all sampling, incubation andtesting activities. Supervisors reviewed the paper records for accuracy and if necessary,corrected the information. Once that was completed, the information was entered into a
database system which also required a review and approval step. We were basically managing
the same information on paper and in the computer.”
The time, effort and cost required to compile and manage this critical information had
become very labor intensive for the QC Microbiology organization.

Improving the Process
ImClone Systems recognized that eliminating paper-based record keeping was the key toimproving the efficiency of its environmental monitoring and quality control program. By
streamlining the process and eliminating redundant and error-prone activities, ImClone
Systems felt it could manage the increased sampling and testing volume with their existing
personnel without overtime. “We had outgrown the old system,” continued McFarland.
“Each analyst spent significant time each day managing paperwork which took time awayfrom more important activities. We needed to get rid of the paper, simplify the process
and generally increase the overall efficiency of the program.”
To go paperless, ImClone Systems needed an automation platform that would collect,manage and report environmental and utility monitoring information. The product had tobe mobile to visit the many sampling sites in its facilities while meeting the strict requirementsof an aseptic environment. ImClone Systems chose MODA-EM to meet these needs.

A Phased Implementation
ImClone Systems’ implementation of MODA-EM was divided into two phases: first, automate
data collection and then manage the environmental and utility monitoring operation. The
initial phase focused on automating the workflow for collecting environmental monitoring andutility samples using MODA’s Field Data Capture (MODA-FDC™) platform. MODA-FDC
leverages wireless computing technology to provide a mobile platform for collecting, labeling(via barcode) and tracking environmental and utility monitoring samples. The automatedworkflow engine that drives the location-based sampling regimens improved productivity andensured compliance with ImClone Systems’ standard operating procedures.
Prior to the implementation of MODA-FDC, paper worklists and sample labels were printed
from ImClone Systems’ legacy system and were used by the QC Analysts to direct theirsampling activities. After each shift, the collected samples had to be reconciled with eachworklist and any errors or missed samples had to be addressed. As a result of implementing
MODA-FDC, ImClone Systems not only significantly reduced sampling paperwork but also
increased the efficiency of the sample collection process while reducing errors and theincidence of missed samples.
The second phase of the project involved replacing the entire legacy system with MODA’sAdministration (MODA-Admin™) and MODA-EM Server products. Using MODA-Admin,
ImClone Systems could easily define and maintain the parameters that govern theirenvironmental and utility monitoring program and express the sampling, incubation andtesting regimens that are used by the MODA workflow engine.
MODA-EM Server, a 21 CFR Part 11 compliant data repository, became ImClone Systems’complete data management platform and system of record for their environmental andutility monitoring information. Moda-EM Server also provided ImClone Systems withimproved decision support and process intelligence functionality through its comprehensive
event notification, data reporting and trending capabilities.

Tangible Business Benefits
ImClone Systems’ justification for implementing MODA-EM was straightforward; eliminate theneed to hire additional QC Analysts and reduce or eliminate mandatory overtime for the existing
staff while meeting the increased environmental monitoring workload that resulted from theBranchburg expansion. Following the implementation, ImClone Systems recognized immediateimprovements. The MODA-EM system generated excitement among the QC Microbiology groupand the staff adapted quickly to it. With the elimination of paperwork, QC Analysts not only wereable to manage the increased sampling and testing volumes but also were able to spend moretime on higher value activities within the microbiology lab.
In addition to improving the acquisition and management ofenvironmental and utility monitoring data, the reporting and trendingof ImClone Systems’ EM and QC data improved dramatically aswell. “The elimination of paperwork had a tremendous impact on
the operation,” concluded McFarland. “We gained back the timethat we had previously spent compiling, routing, reviewing, andfiling paper forms. Because all of the information originates fromwithin the system the need for batch data entry at the end of theshift is also eliminated. With fewer mistakes and less time spent
on reconciliation, the overall efficiency and effectiveness of ouroperation has increased. Our environmental monitoring information
is now available real-time which significantly improves our ability
to monitor and manage our growing facility.”

MODA Technology Partners, Inc.

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