MODA Platform

The MODA® Platform, developed by Lonza, is a digital GMP manufacturing and quality software solution designed specifically for the pharmaceutical industry. It combines manufacturing and laboratory data into a single, comprehensive source to expedite pharmaceutical product release, eliminate paper-based records, and remove manual, error-prone workflows. The platform is user-centric, modular, and scalable, making it suitable for a wide range of organisations — from clinical-phase contract manufacturing organisations (CMOs) to mid-sized and commercial pharma plants.

Built on Lonza's deep expertise in pharmaceutical manufacturing and informatics, the MODA® Platform was developed in response to marketplace gaps — existing solutions were found to be too expensive and insufficiently flexible for customers requiring frequent changes. The combination of Lonza's manufacturing subject matter expertise and its informatics knowledge of paperless solutions in regulated environments resulted in a more flexible and cost-effective alternative to traditional paper records.

Platform Modules

• MODA-ES® Manufacturing — Provides intuitive, flexible, and proof-efficient electronic batch records (EBR) for GMP manufacturing execution.
• MODA-EM® Quality Control — Automates the full spectrum of QC activities, including paperless QC microbiology, removing the need for a separate LIMS in many use cases.
• MODA® eLogs (Electronic Logs Module) — A user-friendly, compliance-enforcing electronic logs solution to replace paper-based logbooks.

Key Applications and Capabilities

• MODA-ES® Electronic Batch Records — Digitises batch record execution to reduce cycle times for review and approval activities.
• MODA-ES® Weigh and Dispense — Supports accurate, paperless weigh and dispense operations within GMP manufacturing.
• MODA-EM® Paperless QC Microbiology — Enables fully digital environmental monitoring and QC microbiology workflows.
• MODA® for CGT Manufacturing — Tailored capabilities to support cell and gene therapy (CGT) manufacturing operations.

Problems the MODA® Platform Solves

• Eliminates issues associated with paper-based batch records, QC forms, and logbooks.
• Reduces long cycle times for review and approval activities.
• Prevents deviations caused by missing entries, incorrect entries, and manual calculation errors.
• Removes duplication of tasks and effort that can arise from running multiple disconnected systems.
• Streamlines traditionally siloed processes into reusable, digital workflows that enable efficient scalability.

Why Choose the MODA® Platform

• Modular and scalable — Organisations can start with the module that best fits their current needs and add additional modules as requirements grow.
• Industry-specific design — Built specifically for pharmaceutical manufacturing and quality operations, addressing the unique compliance and operational demands of the sector.
• Proven track record — Lonza has extensive experience working with customers globally across all therapeutic modalities, supporting timely implementation and long-term digitalization success.
• Cost-effective flexibility — Designed to be more adaptable and affordable than many competing solutions, particularly for CMOs and mid-sized pharma plants with frequently changing requirements.

Learning Resources and Community

• An annual MODA User Group Meeting provides actionable insights vetted by industry leaders who have deployed the software globally, helping organisations navigate successful global deployments.
• How-to guides cover key steps for planning the integration of a fit-for-purpose Manufacturing Execution System (MES) and digital environmental monitoring tools.
• Webinars are available on topics including building modular and scalable processes in GMP environments and accelerating next-generation MES implementation in partnership with organisations such as NNIT and KBI Biopharma.

The MODA® Platform is deployed globally and is suited to organisations seeking a compliant, paperless approach to pharmaceutical manufacturing and quality operations. Its modular architecture allows it to integrate into existing workflows without requiring wholesale system replacement, as demonstrated by customers who have adopted individual modules — such as MODA-EM® — to avoid redundant investments in additional systems like LIMS.