Data-Driven Discovery: Accelerating Cell Line Development with Advanced Analytics
Modern Cell Line Development (CLD) labs generate a large amount of data and require secure data systems and practices to ensure compliance, accuracy, collaboration and knowledge sharing while minimizing potential errors. Errors or inconsistencies in data capture and handling can lead to unreliable conclusions, risking the validity of scientific findings and regulatory compliance.
To address these challenges, labs must establish strict protocols and technologies to guarantee the accuracy and traceability of data throughout the CLD process.
- Connected data systems to support efficient access, sharing and long-term archiving
- Secure and traceable infrastructure to ensure data integrity and regulatory compliance
- Automated data capture to reduce human error and streamline workflows
- Advanced analytics tools to uncover insights, identify trends and support data-driven decision-making
These technologies enhance accuracy, promote productivity and empower teams to collaborate more effectively.
We see a way to save over 14,000 hours of manual data handling time per year.
Accelerate Data Capture, Analysis and Reporting
The solution involves an innovative cloud-based software platform that creates a continuous and robust data foundation throughout the entire CLD process and seamlessly connects early-stage development with later phases.
IDBS Polar empowers biopharma teams by collecting, managing, analyzing and sharing contextualized products and real-time process data. This ensures data integrity, supports regulatory compliance and enables a structured hierarchy of experiments and cell cultures. With faster insights, teams can design better studies, reduce redundant experiments and accelerate time to market.
Cell line development
Many CLD labs still perform manual transcription due to data silos driven by legacy equipment and systems or paper-based data capture, which leads to inefficiencies and risks. IDBS Polar eliminates these issues by enabling
- Standardized, automated data capture and analytics process
- Enhance transparency, traceability and data integrity across teams and workflows
For CLD, tracking passage numbers and maintaining traceability from transfection to clone selection is often tedious. IDBS Polar simplifies this by
- Integrating process and analytical data
- Maintaining cell line genealogy
- Providing quick access to clone history and performance
From day one, users benefit from improved quality and reproducibility. The platform supports integrated inventory management, method documentation, and recipe tracking for consistent execution. It enables automation across workflows—from generating cloning plate layouts and ranking clone measurements to tracking culture freezing, thawing and subculturing—all while capturing accurate audit trails.
With built-in instrument integrations and data visualization tools, Polar provides
- Robust analysis for host cell line and lead clone selection by combining data from various sources and formats
- Support for real-time and retrospective insights
- Custom and pre-built applications for statistical analyses, identifying process variability and predicting outcomes
Adopting IDBS Polar early in development ensures data continuity, supports smoother tech transfer and accelerates the path to market.
Accelerating regulatory filings and approvals
The most effective biopharma compliance strategies begin early in development. Regulatory delays often stem from paperwork, errors and rework. A well-organized, digitally connected data stream can streamline submissions and speed up approvals.
IDBS Polar supports end-to-end digitalization with compliance-ready features, including digital signatures, secure audit trails and a digital chain of custody- meeting GxP, FDA 21 CFR Part 11 and EudraLex V4 Annex 11 requirements.
By integrating advanced technologies and automated data management, labs can ensure regulatory compliance, enhance efficiency and accelerate the delivery of life-changing therapies.
We see a way to accelerate CLD data workflows by 3x.
Streamline Data Analysis and Management
Developing an optimal cell line is essential yet time-consuming and costly. Throughout the CLD process, large volumes of clone performance data are exchanged. Structuring and centralizing this data allows for faster development and enables AI-driven prediction of clone behavior.
Advanced techniques like the multi-attribute method (MAM), next-generation sequencing (NGS) and mass spectrometry replace traditional assays. To fully leverage these, software solutions like Genedata’s suite offer end-to-end digital support, enhancing data traceability, collaboration, and workflow automation with minimal customization.
- Genedata Bioprocess tracks all CLD operations- from cell inventory and passages to analytical results. It integrates with lab automation, monitors key productivity metrics, supports modeling and provides complete clone history reports with one click.
- Genedata Selector brings NGS workflows in-house with guided playbooks for integration site analysis, mutation profiling and CRISPR design. It’s instrument-agnostic, GMP-ready, 21 CFR part 11 compliant and centralizes NGS data for seamless collaboration.
- Genedata Expressionist streamlines MS data processing for protein characterization, reducing analysis time by up to 95%. It supports workflows like HCP profiling and intact mass analysis, ensuring protein quality in less time
Together, these solutions accelerate CLD, support regulatory compliance and drive efficiency by automating complex data-driven processes. To learn more, contact an expert from the Life Sciences companies of Danaher today.