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Process Design

Reduce timelines across cell line development, upstream and downstream process development, formulation, and analytical development.

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Cell Line Development

Upstream Processing

Downstream Processing

Formulation Development

Analytical Development

QbD. Clone selection. Media optimization. CQA monitoring. Optimizing DSP unit operations. Formulation screening. Genedata Bioprocess® acts as an integrated, end-to-end workflow backbone that provides purpose-built functionalities for all applications across bioprocess development.

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.

Formulation Development

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 &
In-Process Control

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.

Vaccine Development

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. In addition to classical vaccine R&D approaches, it supports novel vaccine technologies such as synthetic self-amplifying mRNA, which accelerates vaccine development by utilizing synthetic and cell-free processes. This paves the way for the development of novel vaccines, even for antigens that are extremely difficult to produce and formulate. A dedicated, purpose-built enterprise software platform, it automates complex processes, supports teamwork in a division of labor environment, and integrates new R&D technologies and workflows. In particular, it optimizes vaccine bioprocess development, monitors vaccine product quality, and ensures data integrity and compliance

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