Genedata Bioprocess

Biopharmaceutical Development & CMC

Genedata Bioprocess™ is a first-in-class, off-the-shelf enterprise software solution that makes large-molecule development and CMC activities more efficient and improves process quality. Genedata Bioprocess streamlines and automates complex workflows in cell line development, upstream and downstream process development (USP and DSP) workflows, 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. The system can be used to develop manufacturing processes for both antibodies (IgGs, novel formats, ADCs) and therapeutic proteins (e.g., engineered FVIII variants, and fusion proteins). Genedata Bioprocess has been co-developed with major biopharmaceutical companies over the past four years.

Increasing throughput by automating key steps in the bioprocess R&D workflow is at the heart of Genedata Bioprocess. The platform tracks and documents the full history of each cell line and collects all relevant characterization data, such as productivity and quality parameters, and streamlines the underlying laboratory workflows. The system can be directly integrated with laboratory equipment, including colony pickers, screening robots, bioreactors, and analytical devices. Data originating from different sources and systems are automatically processed, analyzed, and shared between different teams, including all cell line development, expression, purification, formulation, and analytical development groups.

Built on a modular and scalable architecture, the platform is suitable for installations ranging from single-site groups to global, multi-site biopharma development organizations.