One key to reducing R&D costs in the biopharmaceutical market is streamlining and speeding up process data flow for Design of Experiments (DOE). Now, a direct integration of Genedata Bioprocess® platform and Umetrics Suite MODDE® software enables seamless data flow and facilitates the design, execution and evaluation of experiments in large-molecule process development.
The bi-directional integration of experimental data between MODDE® software and Genedata Bioprocess® platform streamlines study optimization and risk evaluation.
Genedata, a leading provider of advanced software solutions for biopharmaceutical R&D, is offering an out-of-the-box integration of the Genedata Bioprocess® platform with MODDE®, the Design of Experiment (DOE) software from Sartorius Stedim Data Analytics. The integration allows the MODDE® (DOE) software to be easily accessed from the Genedata Bioprocess® platform, which acts as a data backbone connecting all planning and actual experimental information from upstream, downstream, formulation, and analytical development units.
This integration capability allows for consistent information exchange between the two systems, ensuring data integrity and streamlining the data transfer and enabling the analysis.
“The bioprocess development market has clear needs for advanced data analytics delivered as an integrated and turn-key solution,” said Prof. Dr. Johan Trygg, Head of Advanced Data Analytics Corporate Research at Sartorius. “With the integration of our MODDE® software with the Genedata Bioprocess® platform, we enable a higher degree of automation capability in the bioprocess development workflow.”
(image provided by Genedata)
Supporting Quality by Design
The integration also promotes more efficient implementation of a Quality by Design (QbD) strategy by providing seamless access to experimental data for modeling, optimization and risk evaluation using MODDE® software.
With this new bi-directional integration, MODDE® experimental design data can be seamlessly imported into the Genedata Bioprocess® platform, where process parameters and experiment results are stored. This data, in turn, can be passed back into MODDE® for optimization studies and risk evaluation.
“Our collaboration with Sartorius Stedim Data Analytics enables fully integrated DOE-experimentation workflows and significantly simplifies our customer’s day-to-day operations, saves time, and lowers their R&D costs,” said Dr. Othmar Pfannes, CEO of Genedata.
Integrating bioprocess development
Genedata Bioprocess® is a first-in-class enterprise software solution that provides fully integrated workflow support for large-molecule development and CMC. As an integrated data backbone, it enables the cost-efficient development of next-generation manufacturing processes, supporting the full workflow – from cell line development (CLD), upstream process development (USP), downstream process development (DSP), formulation development (FD) and analytical development (AD).
Genedata Bioprocess® end-to-end workflow platform:
- Integrates and harmonizes bioprocess development workflows
- Streamlines communication and hand-overs
- Provides real-time access to all project information
- Facilitates high-throughput processes
- Enforces data integrity & compliance
- Enables full automation & scale-up of operations
The platform scales with highest data volumes and integrates all relevant experimental data, including data from bioreactors, purification instruments, or analytics devices. Genedata Bioprocess® has been co-developed with major biopharmaceutical companies over the past five years. Founded in 1997, Genedata is headquartered in Switzerland and has offices in Germany, the UK, Japan, Singapore, and the US.
“Via our Global OEM Partner program at Sartorius Stedim Data Analytics we can offer tailored applications for embedding Advance Data Analytics into most platforms and solutions. Companies that want to add or connect to the leading Design of Experiments or Multivariate Data Analytics software can apply and download our software development kit (SDK)”, says Johan Hultman, Business Development Manager for OEM and Channel Management.
See it live
Genedata Bioprocess® will be showcased in the European Society for Animal Cell Technology (ESACT) presentation, “Industrializing Immuno-Oncology Therapeutic Discovery Platforms,” on Tuesday, May 7, 2019 at 12:20 pm.
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