DataHow and Genedata Partner on Digitalization of Biopharma Process Development and Manufacturing

Genedata and DataHow, both leading innovators for the digital transformation of biopharma R&D, entered a strategic partnership to integrate their platforms to further streamline bioprocess development and manufacturing workflows. The combined solution will directly integrate DataHow’s Digital Twin products, including DataHowLab and SpectraHow, with the Genedata Biopharma Platform so that process development and manufacturing data can be seamlessly exchanged and interpreted. Having experimental data and modelling data available together will streamline digitalization across biopharma process development and manufacturing. This will enable digital tracking of data for every molecule, sample, and process for more efficient process development and integrate state-of-the-art modelling capabilities to better understand and optimize critical attributes of the biopharmaceutical manufacturing process.

DataHow’s platform provides high-performance bioprocess data analysis and predictive modelling tools based on a user-friendly workflow with customized data visualization techniques, hybrid modelling for process understanding and design, and machine-learning to enable self-learning capabilities and knowledge transfer across molecules and scales. Genedata Bioprocess is a fully integrated biopharma R&D workflow platform, which integrates processes and connects people, data, and laboratory instruments to automate corporate-wide development and manufacturing operations. It supports the entire end-to-end (E2E) process, covering cell line development (CLD), upstream process development (USP), downstream process development (DSP), formulation development (FD), process analytical support, and analytical development (AD). The integration of the platforms results in synergies that further drive harmonization and automation along the full process. Additionally, as part of the collaboration, DataHow and Genedata will expand the integrated platform to other innovation areas in process development and manufacturing, including hybrid model-supported process monitoring and control with Raman Spectroscopy and E2E applications of Digital Twins.

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“The development of innovative biotherapeutics, including cell and gene therapies and next-generation vaccines, is based on extremely complex and data-rich R&D processes,” noted Othmar Pfannes, Ph.D., CEO of Genedata. “The Genedata Biopharma Platform enables full automation of experimental workflows due to its flexible data model and open programming interfaces. It also allows emerging technology leaders such as DataHow to integrate their technology platform, minimizing setup and integration work for joint customers and directly creating value out of the generated data. This integration provides the best of both worlds — fully automated high-throughput processes complemented by a comprehensive modelling platform supporting faster and better decision making for process development and manufacturing.”

“Full digitalization of production processes is at the heart of DataHow’s vision. Digitalization will allow users to perform a large majority of tasks related to manufacturing processes in silico and automated. This includes process predictive monitoring, optimization, scenario and deviation analysis, and quality management,” said Alessandro Butté, CEO of DataHow AG. “Both companies share a common vision — providing the biopharma industry with one holistic platform that seamlessly communicates between all involved stakeholders, allowing to manage bioprocess data and knowledge in a comprehensible digital format. Our collaboration with Genedata will streamline the whole biopharma lifecycle from process development to late-stage manufacturing.”

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