When ImClone Systems Inc expanded its drug manufacturing in New Jersey, the company was faced with the possibility of hiring additional personnel for environmental and utility monitoring operations. Instead, it chose Lonza’s MODA Paperless QC Micro solution to automate its processes.
In 2007, Lonza was an early adopter of the MODA technology platform in its own manufacturing operations. It evaluated and selected MODA-EM for its Walkersville, Maryland (US) facility as a result of its company-wide Lean Six Sigma initiative to eliminate waste and cut lead and labour time.
ImClone Systems, founded in 1984, opened its first laboratory in 1986 in New York City. Originally, the company focused on immunology-based diagnostics and infectious disease vaccines. Then, in the early 1990s, it shifted its focus to the development of innovative, biologic compounds in the area of oncology.
The company recently expanded its bulk manufacturing facility in Branchburg, NJ, and, as a result, scaling up the environmental and utility monitoring operations would require the addition of many new technical personnel.
ImClone Systems decided to implement Lonza’s MODA solution with its mobile computing platform to automate the collection, management and reporting of environmental and QC monitoring information, which increased the productivity of its current staff. The new workflow reduced, and in most cases eliminated paper and prevented documentation errors.
By improving the productivity of its QC Analysts, ImClone Systems reduced the hiring requirements to support the expanded facility – a significant cost saving. In addition, the improved accuracy of the new workflow gave ImClone Systems a more robust QC operation.
Leveraging the advances made in the fields of molecular biology, oncology, genomics and antibody engineering, ImClone Systems has built a novel pipeline of product candidates to address specific genetic mechanisms involved in cancer growth and development.
Erbitux*, the company’s flagship product, a monoclonal antibody, was approved in 2004 for treatment of colorectal cancer, and in 2006 for treatment of head and neck cancer. The Branchburg site is the primary bulk manufacturing facility for Erbitux. Commissioned in 2001, the Branchburg site has since grown from two to seven buildings to meet increased demand for the product.
Erbitux is a parenteral drug (i.e. administered by injection) and, like many parenterals, cannot be terminally sterilised. Instead, the drug is manufactured aseptically to minimise exposure of the product 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 contaminants is therefore required according to Good Manufacturing Practice (GMP) guidelines.
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, the paperwork involved with the environmental and utility monitoring regimen was consuming much of the analysts’ time. ‘The process required a lot of co-ordination,’ said Matthew Miner, ImClone Systems’ director of QC Microbiology.
‘Critical information was recorded on paper by the QC analysts for all sampling, incubation and testing 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 on the computer.’
The time, effort and cost required to compile and manage this critical information had become very labour intensive for the QC Microbiology organisation.
To go paperless, ImClone Systems needed an automation platform that would collect, manage and report environmental and utility monitoring information
ImClone Systems recognised that eliminating paper-based record keeping would be a means of improving the efficiency of its environmental monitoring and quality control programme. By streamlining the process and eliminating redundant and error-prone activities, the company felt it could manage the increased sampling and testing volume with its existing personnel without overtime.
‘We had outgrown the old system,’ said Miner. ‘Each analyst spent significant time each day managing paperwork, which took time away from more important activities. We needed to get rid of the paper, simplify the process and generally increase the overall efficiency of the programme.’
To go paperless, ImClone Systems needed an automation platform that would collect, manage and report environmental and utility monitoring information. The product had to be mobile to visit the many sampling sites in its facilities, while meeting the strict requirements of an aseptic environment. ImClone Systems chose the MODA solution from Lonza to meet these needs.
a phased implementation
The implementation of the MODA solution 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 and utility samples using the MODA Field Data Capture (MODA-FDC) platform.
MODA-FDC leverages wireless computing technology to provide a mobile platform for collecting, labelling (via barcode) and tracking environmental and utility monitoring samples. The automated workflow engine that drives the location-based sampling regimens improved productivity and helped confirm 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 used by the QC analysts to direct their sampling activities. After each shift, the collected samples had to be reconciled with each worklist and any errors or missed samples had to be addressed. As a result of the MODA-FDC implementation, ImClone Systems not only significantly reduced sampling paperwork, but also increased the efficiency of the sample collection process, while reducing errors as well as the incidence of missed samples.
The second phase of the project involved replacing the entire legacy system with the MODA solution server software (MODA-EM). Using the MODA-EM administration tools, ImClone Systems could easily define and maintain the parameters that govern its environmental and utility monitoring programme, and express the sampling, incubation and testing regimens that are used by the MODA solution workflow engine.
The MODA-EM server software, with its 21 CFR Part 11 compliant data repository for technical requirements, became the company’s complete data management platform and system of record for its environmental and utility monitoring information. The system also provided ImClone Systems with improved decision support and process intelligence functionality through its comprehensive event notification, data reporting, and trending.
And the MODA-VIP visual intelligence portal offered an even more sophisticated view of the data. Its advanced visualisation capabilities enable a correlation of test results with facility floor plans, offering a complete insight in manufacturing operations.
ImClone Systems’ justification for implementing the MODA solution was straightforward; eliminate the need 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 the Branchburg expansion. Following the implementation, the company recognised immediate improvements. With the elimination of paperwork, QC analysts were not only able to manage the increased sampling and testing volumes, but could also spend more time on higher-value activities within the microbiology lab.
In addition to improving the acquisition and management of environmental and utility monitoring data, the reporting and trending of ImClone Systems’ environmental monitoring and QC data improved dramatically as well.
‘The elimination of paperwork had a tremendous impact on the operation,’ said Miner. ‘We gained back the time that we had previously spent compiling, routing, reviewing, and filing paper forms. Because all of the information originates from within the system, the need for batch data entry at the end of the shift is also eliminated.
‘With fewer mistakes and less time spent on reconciliation, the overall efficiency and effectiveness of our operation has increased. Our environmental monitoring information is now available real-time, which significantly improves our ability to monitor and manage our growing facility.’
*ERBITUX is a registered trademark of ImClone LLC. Unless otherwise noted, all trademarks herein are marks of the Lonza Group or its affiliates