Bioprocess Development. Next-Generation.
Genedata Bioprocess® designs next-generation bio-manufacturing processes across CLD, USP, DSP, formulation, and analytics development. It enforces data integrity and compliance, streamlining development of originator drugs and biosimilars.
Explore Selected Applications
QbD. Clone selection. Media optimization. CQA monitoring. Optimizing DSP unit operations. Formulation screening.
Genedata Bioprocess offers purpose-built functionalities to reduce timelines across cell line development, upstream and downstream process development, formulation, and analytical development.
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Genedata Bioprocess provides out-of-the-box support that is uniquely designed for bioprocess development ‒ it is modular, scalable, and easy to integrate. It allows flexible configuration for customer-specific workflows such as proprietary expression and purification protocols or analytical technologies.
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Learn how Genedata Bioprocess helps leading biopharmas and CMOs integrate and harmonize processes. A team of biopharma development experts provide technology transfer, customizations, training, and deployment support.
Ensure Data Integrity.
Eliminate Compliance Risks.
Acting as a central data backbone, Genedata Bioprocess automatically documents the full workflow. The platform’s audit trail functionalities allow you to easily trace back all data along the full process, which ensures data integrity and regulatory compliance for every step along the workflow. Genedata Bioprocess can be used either in a fully compliant or non-compliant mode.
More than Data Capture.
Data-Driven Decision Making.
With Genedata Bioprocess, data is centrally captured, structured, and stored, which makes it possible, for the first time, to fully exploit its value by analyzing all data both within and across projects. This enables a systematic Quality-by-Design (QbD) approach that identifies and monitors product critical quality attributes (CQAs) and correlates these with critical process parameters (CPP). Cross-project data investigations guide process and technology enhancements to eliminate workflow bottlenecks.
Automate & Industrialize.
Improve Productivity.
By directly integrating with all laboratory instruments such as bioreactors, downstream processing equipment, and analytics devices, Genedata Bioprocess automates data capture, which dramatically improves overall productivity and reduces manual errors. The platform can also be integrated with robotics equipment, enabling full automation and high-throughput processes such as HT formulation screens.