Lonza: industry should shift to QC automation
The industry could benefit from using electronic enterprise resource planning (ERP) systems, document management systems, and laboratory information management systems (LIMS), she says.
Last year the Swiss company installed an automated Laboratory Execution System (LES) – a computer-based way to help technicians perform lab test steps – at its QC labs in Portsmouth, New Hampshire, and Visp, Switzerland.
The use of handwritten testing documentation is a glaring gap in a production chain that is otherwise largely automated, she said, and one that creates opportunities for error and delay: “if we can replace it we can have a more continuous automated flow.”
Speaking at BioProcess International conference in Boston last week, Jean talked through the challenges and results of implementing the automated system at Lonza’s Portsmouth site, which manufactures a range of clinical and commercial biologics.
Jean said Lonza chose to automate its LES to improve data control and quality compliance and to save time. Having all the information in “one visible controlled location” makes the process more secure and efficient, while eliminating manual transcription reduces human error, makes information easier to enter and retrieve (via instrument interfaces), and highlights problems in real-time.
“It’s a great advantage for data analysis – we can find whenever a pipette has been used [throughout the facility],” she said.
While putting the system into practice was largely successful, Jean said there were some difficulties. “Acceptance of change from paper was difficult” for some people working in assay execution and review, she said, and in general, “resistance to change is alive and well.”
She advised organisations planning to implement the same system that “strong stakeholder engagement is critical from the early stages.” Getting busy lab users to focus part of their time on a new project is difficult, and can mean slow adoption of the automated system during the hybrid paper-electronic period.
She also warned of the challenge of “scope creep” – “the better you learn the system, the more you want to do, from the inside and the outside.”
Automating an LES works best in a specific kind of quality control environment, driven by SOPs (standard operating procedures) and producing consistent and controlled results, Lonza’s expert advised.
The site phased in automation so it could gather evidence on its impact before significant investment.
The facility had to create and revise about 6,000 assay forms and come up with a process for executing and reviewing the new versions. Rolling out the LES meant:
- Building chemical and reagent inventories;
- Starting with high-volume forms;
- Installing interfaces (LIMS, simple instruments, and an equipment calibration database;
- Develop subject matter experts in each QC area; and
- Using a sandbox to isolate and test the changes.
At first, Lonza nominated twelve experts within the company to dedicate a quarter to half their time to the project, but later reorganised with four fully dedicated staff. The company also learned “the learning curve for form development was steeper than anticipated. You need full-time staff.”
The changes went live in Portsmouth in April 2014, and 60% of forms currently follow the automated system. Last year Lonza brought in LES in Visp.