#Drug Development #Switzerland #Basel #Genedata #AI-Native CMC

Genedata's Groundbreaking AI-Native CMC Platform

In the dynamic landscape of biopharmaceuticals, Genedata, a prominent player in enterprise software solutions for research and development, has unveiled its newest offering: the Genedata Vico™ platform. This AI-native solution is designed with a singular focus on improving the drug development and manufacturing process within the Chemistry, Manufacturing, and Controls (CMC) domain. With the platform’s capabilities, organizations can significantly enhance their data-driven experimentation, process monitoring, and predictive risk assessment, ultimately bolstering their regulatory readiness while reducing delays in development.

A Collaborative Development Effort

Developed in partnership with leading pharmaceutical companies, Genedata Vico aims to usher a new standard in CMC processes. By aggregating experimental data and metadata from various sources related to both biologics and small molecules, Vico transforms this information into analytical-ready datasets. In doing so, it enhances the transparency and context of data, ensuring organizations can swiftly move towards a more efficient and data-centric way of working.

Genedata recognizes the need for robust data management solutions in a field where the stakes are high, and time is of the essence. To this end, the Vico platform promotes improved collaboration across CMC teams, enabling them to analyze, visualize, and interrogate data with assistance from specialized AI agents tailored for the CMC domain.

AI-Driven Insights and Real-Time Monitoring

One of the platform’s standout features is its incorporation of AI-driven insights, which continuously improve the system's knowledge base by learning from new evidence and outcomes. This is particularly impactful in process analytical technology (PAT), where real-time monitoring of drug quality is paramount during production. Additionally, the platform facilitates AI-assisted design-of-experiments (DoE) and contributes to quality-by-design (QbD) strategies, which are essential for navigating the complexities of pharmaceutical manufacturing.

Genedata Vico is not just another AI solution; it’s intricately designed for the CMC sector, focusing on elements like process automation, data traceability, security, and governance. This specifically tailored approach positions Vico as a premier choice for biopharma organizations, enabling them to transition from document-centered methods to data-centric decision-making paradigms efficiently.

Delivering Tangible Business Impact

The business implications of utilizing Genedata Vico are profound. By leveraging its AI innovations, biopharma CMC teams can potentially recover up to 80% of losses typically associated with failed production batches, an alarming statistic highlighted by industry standards. In addition, the platform could help mitigate up to 15 months of cumulative delays in clinical trial supplies, emphasizing its role in speeding up the journey from drug development to patient delivery.

Othmar Pfannes, Ph.D., President of Genedata, reiterated the shift occurring in the CMC space: “CMC is at an inflection point, driven by the rise of novel modalities, advances in automation, and evolving regulatory frameworks. This creates a timely opportunity for a new, data- and AI-driven approach to CMC.” His insights underscore the potential for Genedata Vico to facilitate real-world decisions while maintaining compliance and transparency within the industry.

Upcoming Presentation and Further Information

To showcase Genedata Vico and its tangible benefits in CMC, Genedata and its pharmaceutical partners will be presenting the platform at the Bio-IT World Conference & Expo from May 19-21, 2026. Those interested in learning about how this innovative solution can elevate biopharma organizations can visit Genedata’s official website at Genedata Vico.

In a world where data plays a central role in biopharmaceutical development, Genedata is committed to empowering organizations with the tools they need to not only succeed but thrive in a competitive landscape. With over 25 years of experience, Genedata remains dedicated to digitalizing complex data workflows and elevating the standard for data-driven decision-making in biopharma.

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About Genedata: Genedata is a Danaher company providing pioneering enterprise software for biopharma R&D, transforming complex data into actionable intelligence. Organizations worldwide trust Genedata to drive innovation and maximize ROI from discovery through clinical implementation.

About Danaher: Renowned for its leadership in life sciences and diagnostics, Danaher accelerates scientific discovery through innovative solutions tailored to solve complex challenges in clinical settings. Together, the Danaher family aids in delivering efficient, life-altering therapies.