MODA-ES CGT Platform Review
The Next-Generation Electronic Batch Record Solution for Cell and Gene Therapy
The Challenge of Managing Complex Manufacturing Data With Paper
Cell and gene therapy (CGT) manufacturing is among the most complex and high
stakes in the pharmaceutical industry, which makes it even more surprising that many organizations still rely on paper batch records and disconnected processes throughout the product lifecycle. This exposes them to unnecessary risk, delays, and heavy administrative burden.
Paper batch records must be completed, copied, transported, and shared physically, creating delays and disruption at every stage. Technicians spend valuable time ensuring documentation is correct, while reviewers and approvers check every entry to verify nothing is missing or incorrect. The result is a process that is time-consuming, error-prone, and costly, where mistakes and omissions lead to deviations, ill-informed decisions, and in some cases, lost batches.
MODA-ES: Transforming Batch Records into Operational Advantage
The MODA-ES (Execution System) Platform is a paperless batch record solution that combines manufacturing and quality control data into a single, connected record, purpose built for the unique demands of cell and gene therapy manufacturing. Designed by end users for end users, the platform transforms batch records from a source of administrative burden into a streamlined, accurate, and efficient process, reducing the time, cost, and labor associated with paper-based approaches at every level of your organization.
With MODA-ES, biopharmaceutical CDMO Lonza is able to process multiple batches simultaneously, increasing utilization and manufacturing capacity without additional overhead.
With usability and cost-effectiveness at its core, the MODA-ES Platform is intuitive to deploy and easy to maintain. Its configurable modular design scales up or down without compromising quality or compliance, and drag-and-drop process building means teams can get up and running without specialized IT skills or lengthy training. That way, your teams can spend less time managing the system and more time focused on production.
Enable Parallel Processing with Track and Trace
Without a connected system, manufacturers are left sifting through physical paperwork just to identify the location or status of a single material. MODA-ES’ Track and Trace solves this problem by providing a real-time electronic overview of everything in the facility at any given time, delivering parallel processing, preventing cross-contamination, and laying the foundation for industrializing cell therapy manufacturing at scale.
The MODA-ES Platform enables a fully paperless process from the moment material enters a facility to when it leaves, covering batch records, electronic logs, and all stages of review and approval. Data is logged and accessible through every stage of storage, processing, and shipment, eliminating the need to physically move or re-enter data across different systems or facilities.
Built on a foundation of cGMP compliance and tracking, the MODA-ES Platform ensures that data and trends are visible, organized, and available in real time, giving manufacturers the transparency and connectivity needed to keep processes compliant, efficient, and focused on what matters most: getting therapies to patients.
From Paper to Real-Time Precision
In CGT manufacturing, every record matters. But manually reviewing every entry on every record is not a sustainable way to ensure quality. The MODA-ES Platform changes that by automatically validating data and calculations against expected parameters, flagging only the records and entries that require attention. Reviewers focus on exceptions, not routine verification, accelerating the approval process without sacrificing consistency.
Using MODA-ES can
reduce data entry
and review times by
50-70%
Beyond review, the platform gives manufacturers real-time control over their processes. Users can configure alerts for when parameters fall outside acceptable ranges, catching issues before they become deviations. The result is a more accurate, more efficient operation with a clear, demonstrable chain of custody supporting data integrity at every step.
Configuration Without Compromise
Unlike customizable systems that create re verification
burdens with every upgrade, the MODA-ES Platform is configurable. That distinction matters: cell and gene therapy customers can upgrade to the newest, most compliant version of the software without customization conflicts or the need to re-verify from scratch. The user-friendly interface supports instructional text, drop-downs, electronic signatures, and checkboxes, making it easy to build and manage processes without specialized IT involvement.
When a new process is needed, existing validated modules can be adapted as templates rather than built from scratch, preserving prior validation work and reducing the time and labor required to bring new workflows online. Combined with equipment integration, automation layers, and enterprise systems, MODA-ES eliminates redundant data entry and operator error, giving manufacturers a leaner, more connected operation built around functionality they actually need.
A Cost-Effective Approach to Batch Record Management
Electronic batch record systems have historically felt out of reach for many pharma companies, perceived as too expensive, too complex, and too rigid to justify the investment. The MODA-ES Platform was built to change that. With an affordable price point, a lower total cost of ownership than traditional systems, and an implementation team with first-hand experience in cell therapy manufacturing, the platform makes paperless execution accessible to organizations of any size.
Minimal initial setup, straightforward validation, and low ongoing IT support requirements mean the investment pays off faster and continues to deliver value over time. For CGT manufacturers ready to leave paper behind, MODA-ES delivers efficiency, visibility, flexibility, and lasting value as your operation grows.