Genedata Biologics 4.0 Enables Large-scale Design, Synthesis, and Testing of Bispecific Antibodies

Integrated biologics data workflow system now supports fully automated, high-throughput next-generation antibody generation and characterization

Vienna, Austria, March 31, 2014

Genedata, a leading provider of advanced software solutions for drug discovery and life science research, today announced the release of Genedata Biologics™ 4.0, the latest version of its enterprise workflow support and data management solution for biologics R&D. This major new release provides novel tools for systematically designing, cloning, expressing, purifying, and testing bi- and multi-specific antibodies. Able to simultaneously co-engage with different antigen targets, these new antibody formats are currently being broadly adopted by the biopharmaceutical industry, primarily for developing the next-generation of oncology and immune system therapies. Genedata Biologics is meeting the challenges of developing these complex multi-specific antibodies by providing new tools to enable more efficient molecule design, production, and characterization. Genedata will present highlights of this latest release at the No linkhandler TypoScript configuration found for key tt_news.. (The Austrian Industrial Association, Vienna; March 31 - April 2).

High-Throughput Next-Generation Antibody Generation and Testing
Genedata Biologics 4.0 enables standardized processing and assessment of next-generation antibody formats (e.g. Fab-scFv, KinH, IgG-scFv, DVD-Ig, tandem-scFv-Fc), including the huge underlying combinatorial complexity of all parametric variants (e.g. linkers, V-domain order, Fc). In addition to supporting established formats, the system can be configured to work with completely novel multi-specific antibody-like molecules, new scaffolds, and proprietary engineering techniques (e.g. Fc-engineering, chimerization, humanization). Automating downstream expression, purification, and characterization processes, Genedata Biologics substantially increases throughput.

Genedata Biologics resolves major bottlenecks in high-throughput molecular biology and cloning processes. These processes are required to systematically generate and validate DNA constructs to express the desired next-generation molecules. The platform supports multi-specific engineering strategies by identifying the most successful combination of antigen binders and formats and scales up cloning and production by directly integrating with laboratory automation equipment. Genedata Biologics also automatically aggregates all assay and analytics results, facilitating decision-making on which candidate to move forward.  

“The next-generation of biotherapeutics are built on bispecifics and other innovative, highly engineered large-molecules such as antibody drug conjugates. Therefore, today’s biopharmas are faced with generating and testing vastly increased numbers of diverse alternative antibody molecule formats,” said Dr. Othmar Pfannes, CEO of Genedata. “This new version of Genedata Biologics can handle increasingly complex and proprietary molecule types and enables the necessary throughput and automation to get new high-quality candidates into clinical development faster. This makes Genedata Biologics the workflow management platform of choice for all biologics R&D organizations.”

Genedata Biologics V 4.0 is available now and shipping directly from Genedata.

Editorial Note: On April 2 at 8:50 am CET, Genedata Biologics will be featured in the HAH Bioassays/Technology II Session -- “High-throughput Design, Production, and Evaluation of Multi-specific Antibodies” -- by Dr. Maria Wendt. To schedule a briefing contact, jackie.thrasivoulos

Genedata Biologics V 4.0 – Highlights

Next-Gen Antibody Design, Cloning, Expression and Purification Support

Version 4.0 enables high-throughput workflows of multi-specific antibody molecules produced in large-scale engineering campaigns. Diverse new molecule formats (e.g. bi- and n-specifics: KinH BsIgG, Fab-scFv, IgG-scFv, Dual V domain IgG, etc.) and relevant cloning strategies, which pose workflow challenges, are addressed by tailored in silico cloning and automation tools for molecule design, DNA synthesis and verification workflows. The platform supports different cloning strategies such as restriction enzyme-based and Gateway. Moreover, it provides an integrated expression and purification sample management for next-gen antibodies, and also manages their assays and analytics data.

New Antibody Variable Region Registration

The new platform includes registration and annotation capabilities for antibody variable regions as basic antigen-binding units. Variable regions are now used as elementary building blocks to systematically design and engineer antibody-like molecules. The dedicated handling of variable regions enables a systematic combinatorial antibody design. In addition, the system tracks the full genealogy of each variable region (e.g. derived from phage or yeast display, hybridoma, B-cell cloning, and potentially undergoing humanization or germlining). Variable regions undergo full registration and annotation logic, which includes binder uniqueness check across all molecules, promotion from clones with full inheritance of ancestry relationship and annotations, DNA insert registration and others.

External Collaboration Platform
Version 4.0 includes a new user group infrastructure, which provides a fine-granular mechanism to control access to sensitive data in a collaborative environment, specifically relevant for external data exchange with CROs and CMOs, or academic and other research and development partners. The system now supports secure data transfers among research partners, which is of vital importance in IP-critical environments.

Optimization of HT Infrastructure  
To cope with ever increasing datasets, Genedata has extended and revamped the Genedata Biologics infrastructure. This is particularly useful for processing and storing unprecedented data volumes generated by antibody clone sequence data produced by next-generation sequencing (NGS) technologies. Substantial development effort has been made to enhance product backbone and infrastructure, which includes new caching mechanisms, sophisticated cache life cycle management, full in-memory-processing of sequence data, and multi-CPU support.

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.
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