October 19,2018
Walkersville, MD (USA) / Basel (CH), 19 October 2018– Lonza will unveil its next-generation electronic batch record execution platform, the MODA-ES™ Software Platform, at the Cell & Gene Therapy Manufacturing Forum from 13-15 November 2018, in London (UK). Building on Lonza’s extensive informatics know-how and vast experience as a contract manufacturing organization (CMO), the new platform offers a flexible and cost-effective solution for consolidating and managing batch and quality data produced across cell and gene therapy manufacturing processes.
Conventional methods of data collection and management, whether electronic or manual, can limit efficiency and productivity significantly and result in workflow deviations. Cell and gene therapy manufacturers typically rely on hybrid solutions of paper combined with multiple electronic systems to collect, store and manage the large amount of batch data they produce. However, the lack of integration between these systems means that users need to manually transfer data from one system to the other, which can be an error-prone and time-consuming procedure. Additionally, paper records are still extensively used to capture batch data, often resulting in missing or incorrect entries, calculation errors, and long review and approval times.
The new MODA-ES™ Software Platform has been designed to consolidate all cell and gene therapy manufacturing batch data, as well as batch-related quality control data, into a single record with an easy-to-use review and approval interface for expedited product release. With data integrity compliance and traceability at its core, the solution captures trends key quality and performance metrics, while eliminating errors associated with manual and paper-based approaches. The MODA-ESTM Platform is flexible, easy to configure, and scalable from clinical through to commercial production.
“The MODA-ES™ Electronic Batch Record Execution Platform brings to cell and gene therapy manufacturers the flexibility and informatics tools they desire to scale their processes without compromising safety or compliance,” said Mike Goetter, General Manager, Informatics, Lonza Pharma & Biotech – Bioscience Solutions. “Built on Lonza’s unique manufacturing and quality control expertise and with a low total cost of ownership, the platform will enable the entire cell and gene therapy development and production industry to go paperless.”
Attendees of the Cell & Gene Therapy Manufacturing Forum can witness Lonza’s new MODA-ES™ Platform and find out about the solution’s key features including:
- Workflow-driven data entry applicable to batch records, sterility tests and cleaning forms
- A modular design allowing individual modules to be created, validated and used across different processes
- Standard methods for processing products of the same family, with the flexibility to vary the raw materials, fill volumes and equipment types used
- An electronic checklist enabling real-time review and approval
- Data-integrity alert capability to trigger timely intervention and resolution of issues
- Seamless integration with other cGMP compliant electronic systems, as well as with analytical equipment, for effortless, reliable data transfer
Further information can be found at Lonza at the Cell & Gene Therapy Manufacturing Forum, 13-15 November 2018 or via www.lonza.com/moda-es.