Genedata Bioprocess、Sartorius Stedimの実験計画（DOE）解析ソフト"MODDE"と連携
Direct integration of Genedata Bioprocess and Umetrics Suite MODDE software enables seamless data flow and facilitates both design and execution of experiments in large-molecule process development
May 2, 2019
Genedata, a leading provider of advanced software solutions for biopharmaceutical R&D, today announced a new out-of-the-box integration of the Genedata Bioprocess® platform with MODDE®, the Design of Experiment (DOE) software from Sartorius Stedim Data Analytics, a leading international data analytics solutions provider. The integration allows the MODDE (DOE) software to be easily plugged into 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 analysis process.
“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. In addition, 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.”
The joint approach for enabling efficient QbD strategies in bioprocess development is empowered by combining experimental workflow management with the power of Design of Experiments (DOE) technology. 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.
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). 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.
“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. “In addition, the plug-and-play functionality enables a straightforward setup of a fully integrated platform, which minimizes installation costs. We look forward to expanding our established Ready-to-Run program to other technologies to further streamline our customers’ bioprocess development operations.”
ESACT - European Society for Animal Cell Technology Editorial Note:
Genedata Bioprocess will be showcased in the ESACT presentation, “Industrializing Immuno-Oncology Therapeutic Discovery Platforms,” on Tuesday, May 7, 2019 at 12:20 pm.
About Sartorius Stedim Data Analytics
As part of Sartorius group, founded in 1870, the company earned sales revenue of more than 1.6 billion euros in 2018. More than 8,100 people work at the group's approximately 50 manufacturing and sales sites, serving customers around the globe. Sartorius Stedim Data Analytics are leading data analytics experts that help organizations in many different industries to get more value from their data using the Umetrics® Suite of Data Analytics Solutions. These solutions help harness the wealth of data, identifying vital elements to improve the results from research, product development and manufacturing processes.