Fresenius Kabi Majority Owned mAbxience Adopts Genedata Bioprocess SaaS Platform to Automate Global CDMO Operations

mAbxience selects Genedata Bioprocess SaaS to harmonize data, ensure traceability, and prepare for AI-driven optimization in global biosimilar manufacturing.

By: AXL Media

Published: Mar 11, 2026, 6:31 AM EDT

Source: The information in this article was sourced from Genedata AG

Digital Transformation in Biosimilar Manufacturing

The global contract development and manufacturing organization mAbxience, a majority-owned subsidiary of the Fresenius Kabi group, has initiated a comprehensive digital overhaul by adopting the Genedata Bioprocess enterprise platform. This transition is designed to create a structured and harmonized data environment across the company’s expansive bioprocess development operations. By moving away from fragmented data silos, the organization seeks to automate workflows that were previously manual and disparate, ensuring that all information generated during the development phase is captured within a single digital ecosystem. According to company leadership, this foundational system is essential for maintaining the rigorous standards required for high-quality biologics production.

Achieving Full Data Integrity and Traceability

As biopharmaceutical R&D becomes increasingly complex, the necessity for a single, integrated platform that connects every facet of development has become a critical operational requirement. The Genedata platform provides mAbxience with the ability to analyze and track data across multiple disciplines, including cell line development, upstream and downstream processing, and formulation. Dr. Ivan Sánchez de Melo, R&D Director at mAbxience, emphasized that the system ensures full data integrity and traceability across all internal groups. This level of oversight is particularly vital for a CDMO navigating the strict regulatory landscapes of global biosimilar markets, where documentation and reproducibility are non-negotiable.

Strategic Shift Toward Cloud Based SaaS Solutions

The deployment of the Genedata Bioprocess platform as a Software-as-a-Service solution represents a significant strategic pivot toward modern, scalable IT infrastructure. By utilizing the Genedata Cloud, mAbxience gains a unified digital backbone that allows for real-time collaboration between teams regardless of geographic location. This cloud-based approach minimizes the burden on internal IT resources while providing a secure environment for tracking end-to-end bioprocess workflows. The move to SaaS not only facilitates faster decision-making through immediate data access but also streamlines the transition of products from the development lab to large-scale manufacturing.