Genedata Bioprocess® is a first-in-class, off-the-shelf enterprise software solution that enables highly integrated large-molecule development. It supports the establishment of more efficient manufacturing processes, which are needed to handle the pipeline of biologics molecules that is growing both in size and diversity. The system streamlines and automates complex workflows in cell line development (CLD) and upstream and downstream process development (USP and DSP) as well as in drug formulation and analytical development. By supporting the complete large-molecule development workflow, it enables biopharmaceutical, biotechnology, as well as contract manufacturing organizations, to more efficiently develop and manufacture novel and generic protein-based therapeutics. Used to develop manufacturing processes for both antibodies (IgGs, novel formats, ADCs) and therapeutic proteins (e.g., engineered blood factor variants, and fusion proteins), Genedata Bioprocess has been co-developed with major biopharmaceutical companies over the past five years.
Genedata Bioprocess is especially suited for early-stage development of biologics manufacturing processes in combination with late-stage biologics candidate profiling. It also supports manufacturing process optimization, characterization, and validation. The system truly integrates all development and CMC activities, such as those handled by upstream and downstream processing groups. By providing a central platform for all of these activities, the system accelerates and improves the drug candidate transition from research to development, as well as the manufacturing process transition from development to manufacturing. It enables scientists to gain knowledge from different manufacturing processes and molecule types and ensures the transfer of this knowledge within and between groups working in research, development, and manufacturing organizations.
Genedata Bioprocess is used by various development and CMC groups at biopharma, biotech and CRO/CMO organizations, bioprocess research groups, research-development interface teams, biologics profiling groups, and manufacturing science groups. Built on a modular and scalable architecture, the system is suitable for installations ranging from single-site groups to global, multi-site biopharma development organizations. The system can be used by small groups of 10 to 20 people focusing on one part of the process development, e. g., cell line development groups, or by complete biologics development/CMC organizations comprising hundreds of people.