Designed to increase the efficiency and quality of vaccine discovery, the end-to-end enterprise platform supports the full development process for novel vaccines and enables faster testing, simplified production, and reduced costs.
QbD. Clone selection. Media optimization. CQA monitoring. Optimizing DSP unit operations. Formulation screening. Genedata Bioprocess® offers purpose-built functionalities to reduce timelines across cell line development, upstream and downstream process development, formulation, and analytical development.
As a fully integrated end-to-end platform, Genedata Bioprocess integrates data capture, analysis, and reporting across all of our bioprocess development operations and serves as our central data backbone to ensure data integrity and compliance.
Tobias Stuwe, Ph.D.
Head of Recombinant R&D
Our decision to adopt the Genedata Bioprocess Platform is based on its ability to directly integrate with our laboratory equipment and automate all data transfer, capture, processing, and data analysis and interpretation.
Sridhar Viswanathan, Ph.D.
Sr. VP, Process Sciences and Manufacturing Operations
We aimed to extend automation and further enhance the efficiency of our cell line, upstream and bioanalytical development operations, and quickly realized that Genedata Bioprocess addresses many of our requirements off-the-shelf, eliminating the need for expensive customization.
Hugo de Wit
We are excited to implement the Genedata Biopharma Platform as a central integrated data backbone to streamline the capture, integration, democratization, and analysis of increasingly complex and diverse data types.
Hisham Hamadeh, Ph.D.
VP, Global Head of Data Sciences
After conducting a pilot project to determine if Genedata Bioprocess had the potential to meet our requirements, we decided to move forward with its implementation.
Sergio Rotstein, Ph.D.
Director, Medicinal Sciences Business Technology
We appreciate the collaborative approach with Genedata, and their unique expertise in biopharma discovery and process optimization.
Markus Enzelberger, Ph.D.
Sr. VP and Head of Discovery, Alliances and Technologies
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.
Prof. Dr. Johan Trygg
Head of Advanced Data Analytics Corporate Research
The Biologics Data Platform makes the highly interconnected biologics R&D processes more efficient.
Heiner Apeler, Ph.D.
Director of Molecular and Antibody Biology
Thanks to Genedata’s flexible business model, we are able to take advantage of Genedata’s unique technology under terms that work well for a company of our size.
Glenn A. Friedrich, Ph.D.
Chief Operating Officer
Cell Line Development
Development of stably expressing, clonal mammalian producer cell lines is a complex, lengthy, and costly process. Large numbers of cell pools and clones must be generated, screened, and tested to identify producer cell lines suitable for industrial, large-scale manufacturing processes, resulting in huge amounts of data that need to be captured, analyzed, and reported. Genedata Bioprocess greatly increases the efficiency of the entire clone selection process—from initial transfection through final clone assessment and the master cell bank (MCB). The platform reduces timelines and costs to generate robust, clonal, and highly productive cell lines for manufacturing processes.
Upstream Process Development
Genedata Bioprocess provides purpose-built functionalities for streamlining upstream process (USP) development. The platform enables systematic testing of raw materials, as well as different process parameters and their combinations to identify the best conditions for optimizing product titers and quality. New bioreactors, in particular scale-down systems such as ambr® and process analytical technologies (PAT), have led to more readout data (online, offline, and at-line), which need to be captured, processed, and analyzed in the context of applied process parameters. Genedata Bioprocess makes the development of both fed-batch and perfusion upstream processes more efficient by supporting the full workflow, starting with cell banking via serial sub-cultivation for both seed train expansion and clone stability assessment to shake flask and bioreactor production runs of any scale. The platform helps to significantly reduce timelines and costs for new upstream processes that can be scaled up for large-scale production of biotherapeutics.
Downstream Process Development
Genedata Bioprocess provides application-ready functionalities for streamlining downstream process (DSP) development. The application of innovative scale-down models for different unit operations and the introduction of new process analytical technologies have produced huge amounts of data that need to be captured, processed, and analyzed in the context of applied DSP parameters. Genedata Bioprocess makes the development of new or optimized downstream processes more efficient by providing a fully integrated infrastructure that tracks all unit operations (e.g., protein A capture, centrifugation, low pH virus inactivation, ion-exchange chromatography, small virus retention, ultrafiltration, and diafiltration). This includes their specific process parameters and raw materials, all combinations of unit operations, in-process samples, and process and product analytical data. The platform helps to significantly reduce timelines and costs for new downstream processes that can be scaled up for large-scale production of biotherapeutics.
Biopharmaceuticals and specifically novel molecule formats are often fragile molecules that tend to come with formulation challenges, such as drug substance stabilization, high-concentration, or high-volume self-administration. These challenges, together with injection pain mitigation, necessitate systematic formulation development. Formulation data derived from testing various stress conditions, needs to be captured, adequately processed, curated, and analyzed for the establishment of stable, easy-to-handle formulations. Genedata Bioprocess increases the efficiency of formulation development by providing a fully integrated tracking and analysis infrastructure for all formulation samples, related formulation parameters, and testing readouts (e.g., CQAs). The platform enables full automation of lab workflows such as high-throughput formulation screens that further reduces costs and shortens timelines.
Analytical Development &
Ensuring process and product quality is of the utmost importance, and thorough characterization of molecules and samples is critical for an integrated, QbD-driven approach to process development. Process analytical techniques (PAT), as well as offline analytics methods produce huge amounts of complex readouts, including data from different laboratories and external CROs and in diverse formats (e.g., spectroscopy, titer, endotoxin, SEC, UPLC, MS, SPR, DLS, ELISA data). This data needs to be captured, integrated, processed, and analyzed for the establishment of robust, reproducible analytical tests and to provide analytical support to assess process and product quality in the context of process development. Genedata Bioprocess enables a fully integrated approach to the analytical characterization of large molecules and bioprocesses. All data is centrally captured, managed, analyzed, and made accessible to all involved parties along the process. The platform helps to significantly shorten timelines and reduce costs, enabling the characterization of large amounts of samples in the highest quality.