Genedata Biologics 5.0 – Antibody Engineering and Developability Assessment Advances

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New tools for protein engineering address developability and manufacturability requirements

Genedata Biologics

Integrated tools for biologics R&D operations

Genedata Biologics enables a tightly integrated process of candidate engineering, testing, and selection and simultaneously optimizes biological parameters as well as manufacturability and formulability.

Genedata, a leading provider of advanced software solutions for drug discovery and life science research, today 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.”

Editorial Note: On May 7 at 3:20 pm EDT, Genedata Biologics will be featured in the PEGS Engineering Bispecific Antibodies session -- “High-Throughput Design, Production, and Evaluation of Bispecific Antibodies” by Maria Wendt, Ph.D., Head of Science. To schedule a briefing, contact biologics(at)genedata(dot)com.

About Genedata
Genedata transforms data into intelligence with a portfolio of advanced software solutions, which make research data accessible and understandable and research processes more efficient. These solutions are used worldwide by leading pharmaceutical, industrial, and agricultural biotechnology companies as well as academic research organizations. Genedata innovations enable scientific discovery that fights disease and improves health and quality of life worldwide. Founded in 1997, Genedata is headquartered in Switzerland, and has offices in Germany, Japan, and the US.
http://www.genedata.com
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The statements in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to contract cancellations, developing risks, competitive factors, uncertainties pertaining to customer orders, demand for products and services, development of markets for the Company's products and services. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

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Allison Kurz
Genedata
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