- Andiyanto Sutandar, Consulting Director, NNIT.
-Sagitta Sadewa, Senior Consultant, NNIT.
Designed specifically to be highly customizable and user-friendly, Lonza’s MODA-ES® platform is particularly well-suited for Cell and Gene Therapy (CGT) / Advanced Therapy Medicinal Products (ATMP), biologics manufacturing processes, as well as Active Pharmaceutical Ingredient (API) fill and finish applications.
NNIT has collaborated closely with Lonza for years in the fields of implementation and validation, contributing significantly to the platform’s features, development and realization.
The MODA-ES® platform distinguishes itself as an agile and efficient workflow-driven alternative to conventional Manufacturing Execution System (MES) solutions. Its development began when Lonza identified the need for an MES solution that better suits the specific challenges of CGT manufacturing services.
As a leading Contract Development and Manufacturing Organization (CDMO), Lonza manages multiple customers with diverse products at various stages of drug discovery and development. The platform is designed with a flexible, user-centric approach to easily configure, scale and streamline manufacturing flows, addressing numerous manual processes, analytical equipment requirements, and the evolving pharmaceutical manufacturing needs.
The MODA-ES® platform integrates location, equipment and material management modules combined with a workflow engine and user-friendly interfacing solutions, facilitating rapid deployment and adaptation to new equipment, products, processes and technologies. This design makes it exceptionally suitable for the dynamic pharmaceutical manufacturing landscape, where traditional MES solutions often prove inflexible and are typically tailored for standard manufacturing environments.
As an integrated platform, MODA-ES® supports end-to-end digitalization from research and development to production and quality control, consolidating manufacturing and laboratory data into a unified source. Designed based on Lonza’s extensive experience as a CDMO, the platform leverages industry best practices to optimize various phases of pharmaceutical production, with the goal of achieving expedited paperless execution.
Overview of the MODA-ES® Platform
The MODA-ES® Platform is comprised of two modules, each focusing on a separate aspect of pharmaceutical production:
- MODA-ES® – Manufacturing: This module serves as a flexible and affordable MES, that is easy to configure and use.
- MODA® eLogs – Electronic Logs: Maintains electronic logs for seamless task execution, scheduling, reviewing, and record-keeping.
Additionally, there is a module known as MODA-EM®, widely regarded for its full spectrum capability on automating Environmental Monitoring (EM) and Quality Control activities.
NNIT’s experience with MODA
Over the years, Lonza and NNIT have maintained a longstanding mutually beneficial cooperation, collaborating on multiple MES implementation projects. NNIT has also handled validation, recipe configuration and conducted training for the use of MODA® platform.
"NNIT has worked closely with Lonza MODA since the early versions of the MODA® platform. Our early involvement allows us to actively participate in the development and contribute to the growth of the platform through continuous feedback loops and dialogue”, says Andiyanto Sutandar, Consulting Director at NNIT.
"The experience working with the Lonza MODA team on various MES projects has been excellent, as NNIT and the MODA team collaborate closely with positive momentum and substantial progress. It is great to have the opportunity to grow with an MES Solution through different versions and experiencing the evolving features firsthand.”, says Sagitta Sadewa, Senior Consultant at NNIT.
Selected references:
Implementation of MODA eLogs – Electronic Logs to a CGT manufacturing facility
NNIT supported the implementation of electronic logbook (eLog) module to a CGT manufacturing facility. The location, material and equipment modules were fully utilized to achieve a seamless status and process control. The eLog deployment included management of location and equipment such as biosafety cabinet, pH meter, osmometer, welder, magnetic stirrer and vial filling equipment.
The versatility of the workflow engine makes it possible to develop eLog processes suitable for various usage, cleaning and maintenance activities, with robust material and equipment controls in place. Being able to readily integrate the equipment, location and material status and master data simplifies the deployment. Configurable features included field layout, electronic signature types (e.g., verifier needs, multiple executors), mandatory fields, states, and rich text capabilities.
Implementation of MODA-ES – Manufacturing to a Fill and Finish manufacturing facility
NNIT facilitated the implementation of electronic logbook (eLog) and electronic batch records (eBR) modules at a Fill and Finish manufacturing facility. This involved managing equipment and location usage and cleaning procedures, including autoclaves, ovens, integrity testers, and line clearance activities. Key manufacturing processes such as product filling, processing, capping, sterilization, packaging, and storage were also developed.
The platform’s interface capability enables seamless integration with shop-floor equipment, such as electronic scales. Integration with Enterprise Resource Planning (ERP) systems like SAP enhanced the effective management of production planning, material flow, goods movement, and time confirmation. The implementation further encompassed weighing and dispensing of active and inactive ingredients, along with a comprehensive bill of materials management.
