Bioprocess

Genedata Bioprocess is a comprehensive platform designed for next-generation bio-manufacturing processes, covering cell line development (CLD), upstream processing (USP), downstream processing (DSP), formulation, and analytics development. It ensures data integrity and compliance, facilitating the development of originator drugs and biosimilars.

The platform uniquely integrates and centrally manages all data across biopharma development and Chemistry, Manufacturing, and Controls (CMC) workflows. It enhances efficiency and supports advanced technologies, such as highly parallel scale-down bioreactor panels and complex DSP unit operations.

Genedata Bioprocess offers out-of-the-box support for bioprocess development, being modular, scalable, and easy to integrate. It allows flexible configuration for customer-specific workflows, including proprietary expression and purification protocols or analytical technologies.

Key Functionalities

• Quality by Design (QbD) strategy implementation
• Clone selection and media optimization
• Critical Quality Attribute (CQA) monitoring
• Optimization of DSP unit operations
• Formulation screening

Acting as a central data backbone, the platform automatically documents the full workflow, ensuring data integrity and regulatory compliance. It features audit trail functionalities for easy data traceability.

Genedata Bioprocess enhances productivity by automating data capture through direct integration with laboratory instruments, such as bioreactors and analytics devices. This integration reduces manual errors and supports high-throughput processes, including HT formulation screens.

The platform supports data-driven decision-making by centrally capturing, structuring, and storing data, enabling a systematic QbD approach. This approach identifies and monitors product CQAs and correlates them with critical process parameters (CPP), guiding process and technology enhancements.

Genedata Bioprocess is supported by a team of biopharma development experts who provide technology transfer, customizations, training, and deployment support, ensuring seamless integration and harmonization of processes for leading biopharmas and contract manufacturing organizations (CMOs).