Genedata Vico AI-native CMC Platform

Genedata is an enterprise software provider for biopharma R&D, founded in 1997 and headquartered in Basel, Switzerland, with offices in Boston, San Francisco, London, Munich, Tokyo and Singapore; it is now a Danaher company. Its platforms Biologics, Screener, Bioprocess, Chromatics, Expressionist, Profiler and Selector digitise discovery, development and quality workflows for large pharma and biotech firms.

Genedata Vico, launched in May 2026, is an AI-native solution for chemistry, manufacturing and controls (CMC). It turns experimental data and metadata from biologics and small-molecule development into audit-ready data products with preserved lineage, lets teams apply open, proprietary or commercial AI models with versioning and lifecycle management, and offers CMC-specific AI agents. It supports AI-augmented process analytical technology, AI-assisted design of experiments and quality by design, and provides a GxP-grade remote MCP server for agentic frameworks.

• CMC data products: harmonised experimental data and metadata with preserved lineage.
• Model lifecycle management: apply open, proprietary or commercial AI models with tracking and versioning.
• CMC AI agents: agents for analysing and visualising development and manufacturing data.
• AI-augmented PAT: real-time drug quality monitoring during production.
• AI-assisted DoE and QbD: support for design of experiments and quality by design.
• GxP-grade MCP server: remote Model Context Protocol server for agentic frameworks.

Vietnamese vaccine and biologics manufacturers can use AI-augmented PAT and DoE to improve process robustness and reduce failed batches. CDMOs in the region can deliver audit-ready CMC data packages to international clients. Generic drug producers upgrading to EU-GMP can centralise development and QC data for regulatory filings.

Benchmarks by top 10 biopharma companies suggest Vico can help recoup up to 80% of losses from failed batches. The same benchmarks indicate it can avoid up to 15 months of cumulative clinical trial-supply delays per year. Audit-ready data with preserved lineage supports GxP quality reviews. Model tracking and versioning let quality teams govern AI use in regulated manufacturing.

Biopharma manufacturers are applying AI to process development and quality control to cut batch failures and speed up supply for trials. Southeast Asia is growing as a biologics and CDMO hub, and Vietnam's vaccine and biosimilar producers are building GMP capacity that will need structured, audit-ready process data.

Founded in 1997; headquartered in Basel, Switzerland, with Genedata Pte Ltd in Singapore and Genedata KK in Tokyo. A Danaher company. Vico received the 2026 Bio-IT World Innovative Practices Award for Real-World AI. Customer logos include Pfizer, Sanofi, Amgen, Roche, Novartis, Takeda and Daiichi-Sankyo.