Genedata Bioprocess

Upstream Processing

Upstream process development (USP) is a critical step in bioprocess development. The systematic testing and assessment of different process parameters and their combinations can have a profound effect on 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), that need to be captured, processed, and analyzed in the context of applied process parameters.

Genedata Bioprocess® makes the development of new or optimized fed-batch and perfusion upstream processes more efficient by supporting all workflows, 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 when generating robust and high-yield upstream processes to be upscaled for large-scale production of protein therapeutics.

Integrate

Integrates the full upstream development process with biological cell line information, as well as with downstream and product analytics information, making upstream process development more comprehensive and systematic

Capture

Captures all online, offline and at-line data (e.g., product titer, viable cell density (VCD), lactate and other metabolite data, pH, oxygen, metabolic data), together with all process parameters, raw materials (e.g., media, buffers) and biological cell line information 

Process

Processes cell culture growth characteristics and automatically calculates relevant parameters, e.g., Integrated Viable Cell Density, specific productivity (Qp/SPR), consumption rates

Interpret

Interprets and analyzes all factors required to guide upstream process development, including optimization of media and feeding strategies and other process parameters, process upscaling, as well as process characterization and validation, using built-in tools, providing a comprehensive view on clone behavior under simulated manufacturing conditions

Report

Reports and documents the full process and all results, including cell maintenance and expansion workflows, bioreactor production runs, and harvested batches - together with process and analytical data 

Enable

Enables truly high-throughput, parallel assessment of large panels of clones and upstream processes (e.g., using scale-down bioreactors such as ambr15® and ambr250®) to identify the optimal combination of process parameters