Genedata Bioprocess®は、細胞株構築（CLD）・上流プロセス（USP）・下流プロセス（DSP）・製剤・分析それぞれを跨いで、バイオプロセス開発とCMCワークフローを統合・標準化します。データインテグリティとコンプライアンスを促進し、ワークフロー全体の効率を大幅に向上させます。
Our Customers
Seamless access to all experimental data stored in Genedata Bioprocess, in combination with MODDE software capabilities for modelling, optimization, and risk evaluation, promote an efficient implementation of a Quality by Design (QbD) strategy.
Without having to embark on a lengthy and costly customization project, Ferring was able to take advantage of Genedata’s off-the-shelf platform and immediately start using the software across all our R&D sites.
Searching for a new R&D digital platform, we shortlisted several vendors but only Genedata’s platform included out-of-the-box business logic for protein screening, engineering, and production and this is what won it for us.
- Bioprocess Development
- Cell Line Development
- Upstream Process Development
- Downstream Process Development
- Formulation and Analytical Development
Driving Strategic Bioprocess Design
Early decisions such as clone selection and media choice shape purification strategies, formulation stability, and scalability. Genedata Bioprocess unifies these disciplines in a data-driven environment, enabling systematic identification of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) while supporting Quality by Design (QbD) principles. This integrated approach accelerates progression from early to late-stage development.
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Accelerating Cell Line Development with Intelligent Workflows
High-performing clones are critical for success. Clone screening, selection workflows, high-throughput data integration, and stability studies require automation and standardization to ensure reproducibility. Genedata Bioprocess automates these processes to accelerate clone identification, streamline cross-functional data sharing, and increase process consistency. These capabilities shorten development timelines and deliver more reliable outcomes.
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Optimizing Upstream Processes with Integrated Data Workflows
Critical upstream activities — such as media optimization, cell culture strategy development, scale-down model qualification, and process parameter optimization — depend on fast, reliable access to connected bioreactor and productivity data. Genedata Bioprocess delivers integrated data capture and analysis to establish robust, scalable upstream processes. By enabling rapid condition optimization, deeper process understanding, and reliable regulatory traceability, unified workflows create a strong foundation for commercial-scale production.
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Streamlining Downstream Development for Higher Purity and Yield
Purification success depends on consistent CQAs and reliable workflows. Genedata Bioprocess connects data across batches and unit operations to streamline downstream purification, improve yield, and enhance product purity while ensuring complete traceability throughout development.
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Smarter Formulation and Analytical Strategies for Faster Drug Development
Formulation screening and analytical characterization require structured workflows, reliable data, and full compliance. Genedata Bioprocess strengthens these strategies with tools that accelerate data review, ensure compliance, and improve decision making across development teams. These capabilities enable faster delivery of therapies to market.
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Out-of-the-Box Support for Bioprocess Development
Genedata Bioprocess delivers modular, scalable capabilities that integrate seamlessly into existing environments. The platform supports flexible configuration for customer-specific workflows, including proprietary expression systems, purification protocols, and analytical technologies, providing out-of-the-box functionality designed for bioprocess development.
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Generate Actionable Insights With AI
With Genedata’s enterprise-grade, decision-centric AI platform for digital CMC, teams can easily create and manage CMC digital assets as governed, reusable data products, apply specialized agentic AI, and use leading AI/ML models to guide confident and dynamic decisions in a GxP-compliant environment.
Meet Our Customers
Discover how leading biopharma companies and CMOs use Genedata Bioprocess to integrate, harmonize, and scale development processes. Genedata’s bioprocess and digitalization experts deliver technology transfer, configuration support, training, and deployment services to ensure successful adoption.
Why Choose Genedata Bioprocess for Bioprocess Development?
Genedata Bioprocess streamlines and automates bioprocess workflows to accelerate development, improve data quality, and reduce operational complexity. By connecting scientific performance with commercial outcomes, the platform enables biopharma organizations to minimize risk, shorten timelines, and scale operations with confidence.
- Ensures Data Integrity
- Integrates & Connects Data
- Automates & Industrializes Workflows
- Accelerates Decisions & Leverages Analytics
- Scales Processes for Technology Transfer
Maintain Compliance and Full Traceability Across Workflows
Genedata Bioprocess creates a unified scientific data ecosystem that consolidates information from instruments, LIMS, ELNs, and automation systems. Centralized dashboards and reporting deliver full visibility into project status and progress, while role-based access, audit trails, and secure data handling ensure compliance and complete traceability across workflows.
Centralize Bioprocess Data and Enable Collaboration
Genedata Bioprocess integrates data from instruments, LIMS, ELNs, and automation systems into a single, connected platform. By linking upstream, downstream, and analytical workflows across sites, the platform enables cross-functional collaboration and data sharing. Centralized, structured data supports analysis across projects, monitoring of CQAs, correlation of CPPs, and identification of workflow bottlenecks.
Boost Productivity Through High-Throughput Automation
Connectivity with lab instruments and robotics data enables Genedata Bioprocess to automate data capture, processing, and reporting. High-throughput workflows, such as formulation screens, reduce manual effort and errors while accelerating development timelines. The platform orchestrates diverse data streams across biopharmaceutical development workflows to industrialize processes.
Turn Data into Actionable Insights for Smarter Bioprocessing
Real-time dashboards, built-in analytics, and AI/ML integration enable data-driven process optimization and predictive modeling. The platform identifies bottlenecks, improves outcomes, and aligns development decisions with long-term commercial goals, maximizing ROI and scientific impact.
Support Technology Transfer and Scale-Up with Confidence
Scalable data models and adaptable workflows enable seamless technology transfer from lab to production while maintaining consistency and regulatory compliance. Genedata Bioprocess supports efficient scale-up by connecting development data with manufacturing operations, ensuring continuity and reducing risk during commercialization.