Genedata Biologics 5.0 from Genedata
Product News May 08, 2015
Genedata has announced the release of Genedata Biologics 5.0, the latest version of its enterprise solution for biologics R&D. This first-in-class workflow platform for biopharma R&D enables more efficient discovery and development of novel biotherapeutics.
Version 5.0 enables a holistic approach to integrate and address protein optimization and developability requirements. Genedata will present highlights of the latest release at PEGS Protein Engineering Summit (Seaport World Trade Center, Boston; May 4 - 8).
Engineering the Next-Generation of Antibody Therapeutics: Developability & Manufacturability
Protein engineering is key to transform leads into candidates that can be developed into drugs that meet multiple requirements, which include bioactivity, immunogenicity, serum compatibility, stability, and manufacturability. Focusing on these factors early during antibody engineering allows the design and identification of the most robust and fit candidates, which have increased probability of successful technical development.
Genedata Biologics 5.0 provides new tools for antibody optimization workflows for both standard and novel antibody formats, such as bispecifics and ADCs. This includes tools for directed and undirected mutagenesis methods to simultaneously improve multiple parameters such as affinity or expressibility; graft handling to support humanization of animal-derived antibodies in order to eliminate immunogenicity risks; library design; sequence verification and SAR (Structure-Activity Relationship) analysis; and advanced prediction of physico-chemical properties to further support high-throughput expressibility studies. The platform interacts seamlessly with all relevant laboratory automation and testing equipment and enables true high-throughput engineering, analytics, and QC processes.
Built-in candidate developability assessment allows transparent decision making on the engineered candidates to be selected and moved forward. An intuitive traffic light system enables the simultaneous analysis and interpretation of a multitude of decision criteria, including hydrophobicity, aggregation, micro-heterogeneity, PTMs, charge variants, isoelectric point, serum compatibility, stability (pH, UV, thermal), manufacturability, and pre-formulation criteria such as viscosity and solubility.
In addition, Genedata Biologics features a new Patent Module tailored specifically for the filing of protein therapeutics patents, which greatly facilitates the patent submission process. The Patent Module is fully integrated in Genedata Biologics and is used by both scientific inventors as well as patent councils to protect the IP of newly engineered molecules.
"The new Genedata Biologics 5.0 enables a fully integrated approach to antibody engineering by incorporating technical development requirements right from the onset," said Dr. Othmar Pfannes, CEO of Genedata. "Development candidates often fail late in the R&D process, triggering huge costs. Genedata Biologics enables a tightly integrated process of candidate engineering, testing, and selection and simultaneously optimizes biological parameters as well as manufacturability and formulability. This reduces the risk of encountering unexpected obstacles during development. Our business model of partnering with industry leaders continues to drive the development of Genedata Biologics, which is becoming the workflow management platform of choice for innovative biologics R&D organizations."