Genedata, a Danaher company, and the leading provider of enterprise software solutions for biopharma R&D, announced the launch of Genedata Vico™, an AI–native solution to accelerate CMC processes by enabling data-driven experimentation, process monitoring, and predictive risk assessment — helping organizations strengthen regulatory readiness and reduce development delays. The solution and its real-world impact at a top 10 biopharma were recognized by Bio-IT World with the 2026 Innovative Practices Award for Real-World AI.

From Documents to Data-Driven CMC and Agentic AI

Genedata Vico was developed with pharmaceutical company partners to bring together experimental data and metadata from diverse sources in both biologics and small molecule development and manufacturing, transforming them into audit- and analysis–ready data products that preserve data context and lineage. Within a high-performance development environment, Genedata Vico enables CMC data scientists to apply openly available, proprietary, or commercial AI models with full tracking, versioning, and lifecycle management.

The solution enables teams across the full CMC organization to analyze, interrogate, and visualize data, with the support of CMC-domain-specific AI agents. AI–driven insights continuously feed back into the system, allowing models to learn from new evidence and outcomes. This enables AI-augmented process analytical technology (PAT) for real-time monitoring of drug quality during production, as well as AI-assisted design-of-experiments (DoE) and data-driven support for quality by design (QbD) across CMC.

An AI-Native Solution Made for CMC, Delivering Business Impact

Unlike general-purpose, AI-based solutions on the market, Genedata Vico is the only enterprise-level system that was built for the CMC domain, with its focus on process automation, data traceability, security, and governance. Using this purpose-built solution, biopharma CMC organizations can move efficiently from a document–centric to a data- and decision-centric paradigm. Genedata Vico's advanced scientific reasoning capability was built on Anthropic's Claude frontier model family and can be expanded to other foundation models. The solution also provides a GxP-grade, remote Model Context Protocol (MCP) server, allowing seamless integration into organization-wide agentic frameworks.

Benchmarking by top 10 biopharmas shows that by leveraging the AI-driven innovations offered by Genedata Vico, biopharma CMC organizations can expect to recoup up to 80% of losses typically incurred from failed batches, based on industry averages. They can also avoid up to 15 months in cumulative clinical trial-supply delays per year – ultimately, helping organizations move therapies from development to patients faster.

"CMC is at an inflection point, driven by the rise of novel modalities, advances in automation, and evolving regulatory frameworks", said Othmar Pfannes, Ph.D., President of Genedata. "This creates a timely opportunity for a new, data- and AI-driven approach to CMC. Genedata Vico enables pharmaceutical industry to capitalize on AI and put their data in motion, accelerating real–world decisions while maintaining transparency, trust, and regulatory compliance."