Biotherapeutics Development & CMC.
From cell line development and upstream and downstream process development to formulation and analytics development, removing data-processing bottlenecks remains a challenge. How can you shorten project timelines, structure and automate complex bioprocess development analyses — such as mass spec and next-generation sequencing-based techniques — and eliminate expensive data-handling errors?
This is where Genedata comes in.
Our Customers
- Structured Data. Compliant.
- Cell Line Development. Optimize Selection.
- Upstream Processes. Enhance Productivity.
- Downstream Processes. Purity & Yield.
- Formulation Development. Stable & Bioavailable.
- Analytical Development. Ensure Quality. Mitigate Risks.
Structured Data. Compliant.
- Capture the entire end-to-end process development and CMC workflow using an integrated, structured data backbone.
- Leverage out-of-the box GxP compliance capabilities, including validation-ready audit trails.
- Automate timed-stamped and digitally signed reporting, such as certificates of analysis, signed analytics reports, and clone-history reports.
- Capture and integrate data automatically across instruments and assays to accelerate decision-making.
- Communicate with liquid handling and robotics systems and generate unique barcodes or track existing ones for high-throughput processes.
Cell Line Development. Optimize Selection.
- Streamline the selection of high-yielding cell lines with advanced technologies such as mass spectrometry and NGS.
- Track all plate operations, passages and expansions, and manage cell inventory, register pools, clones, and analytical results all in one place.
- Integrate directly with bioreactors and analyze on-line, off-line, and at-line data while efficiently monitoring key characteristics.
- Analyze and visualize data in dynamic and interactive plots and panels to rapidly select the best clones and perform mechanistic modelling of clone behavior.
- Easily deploy omics and NGS workflows and seamlessly connect them to cell line batches for comprehensive evaluation.
Upstream Processes. Enhance Productivity.
- Improve overall productivity and reduce manual errors dramatically by evaluating complex time course data from multiple instruments and bioreactors in a single platform.
- Develop both fed-batch and perfusion upstream processes more efficiently – from cell bank thawing for seed train expansion to shake flask and bioreactor production runs – at any scale.
- Track all workflow steps, batches, and results, including seed train hierarchy and material splitting and pooling.
- Aggregate results automatically from all runs and seamlessly leverage Design of Experiment (DoE) methodology.
- Register and track all raw materials for every batch to support resource planning for quality assurance and risk management.
Downstream Processes. Purity & Yield.
- Comprehensively capture all unit operations and their parameters during DSP development, including fractions, splitting, and pooling.
- Analyze, visualize, integrate, and automate all chromatography and CE data handling on one platform.
- Automate high-throughput mass spectrometry-based characterization and QC to efficiently maintain quality standards and quickly adjust process conditions.
- Track and analyze results throughout the entire DSP workflow to identify optimal conditions for the best purification processes.
- Reduce DSP development timelines and costs and efficiently scale up for large-scale production.
Formulation Development. Stable & Bioavailable.
- Automate systematic development and high-throughput screens for quicker identification of optimal formulations – even for new modalities.
- Capture all information on excipients and test their compatibility and effect on formulation design. Automatically flag issues and maintain data quality and integrity.
- Integrate with robotic equipment and DoE software to optimize formulation by adjusting variables such as excipient ratios and processing conditions.
- Automate comprehensive and accurate reporting throughout formulation development to facilitate smooth regulatory review.
Analytical Development. Ensure Quality. Mitigate Risks.
- Identify and monitor critical quality attributes (CQAs) and critical process parameters (CPPs) for all assays and ensure consistent and accurate method transfer between different laboratories and scales.
- Optimize performance requirements of analytical methods by continuously integrating product and process learnings in a central data platform.
- Ensure data quality, collaborate with teams, and manage and validate analyses across diverse analytical methods on a dedicated analysis platform.
- Interpret complex datasets and develop assays to assess variability and mechanisms of action with built-in data integrity and consistency checks
- Harness real-time access to all analytical data throughout process development with integrated tools for requesting additional tests and tracking samples.
Customer Stories
Streamlining CLD with Data-Driven Insights
Find out how Sartorius and Genedata accelerate cell line development with data management and modeling, enhancing efficiency and quality in biological manufacturing.
Ajinomoto Accelerates Media Development
“Genedata accelerates cell culture media development, enabling our biopharma partners to create innovative treatments and vaccines faster and at a lower cost.” Hiroyuki Mise, Ajinomoto.
Sartorius Triples CLD Productivity
“Genedata has tripled our productivity, allowing us to develop three times as many cell lines with the same team.” Hugo de Wit, Sartorius.
Ferring Boosts Bioprocess Development
Find out how Ferring uses Genedata to enhance development operations and data quality for antibody, gene therapy, and microbiome therapies, integrating diverse data sources to streamline workflows.