Genedata Biologics Introduces New Protein Production Data Management Platform

Genedata, a leading provider of advanced software solutions for drug discovery and life science research, has announced Genedata Biologics™ 2.0. A first-in-class, enterprise data management solution, Genedata Biologics advances end-to-end biologics R&D activities spanning antibody screening, protein engineering, and biologics production. Version 2.0 provides new protein production modules supporting the full biologics production process, including molecule definition and cloning, expression, purification, analytics, and quality control. This new functionality serves the needs of biologics discovery and protein sciences as well as cell culture and bioprocess development, biopharmaceutical development, protein technologies, and protein supply departments. Protein production modules may be used alone or with existing screening and engineering modules.

"Protein production in an industrialized environment is a complex exercise in which many departments need to interact," noted Dr. Othmar Pfannes, CEO of Genedata. "In this environment, production efficiency and quality is often limited by a lack of direct access to critical information such as plasmid or cell line information. Inconsistent nomenclature among different groups impacts handovers and these challenges are compounded by additional bottlenecks that arise from labor-intensive and error-prone steps such as manual vector design. The latest release of Genedata Biologics addresses these bottlenecks in protein production making it the platform of choice for all biotechnology organizations, including biologics research groups, and development and manufacturing organizations with no or only limited discovery operations."

Genedata Biologics for Biologics Production

Genedata Biologics is a fully integrated data management platform for all biologics molecules, samples, analytics and assay data. The system can be used for the production of therapeutic antibodies and proteins, as well as tool proteins, such as antigens. Based on client-server architecture, Genedata Biologics features an interactive and intuitive web-based interface, which allows users to easily access, manage, analyze, and share information at all stages of the protein production process. While Genedata Biologics provides extensive built-in business logic, it can be configured to address corporate-specific workflows and standards.  

The system handles complex workflows in a division-of-labor environment and provides tailored functionalities for facilitating sample and data handovers between sites and groups. Different groups along the protein production process use the system to access data for daily work and for registering experimental results to support downstream activities. New functionality in Genedata Biologics 2.0 Protein Production modules includes:

Molecule Registration: Central registration of recombinant proteins and complex biologics, both therapeutics and reagents, including various antibody formats (Fabs, IgGs, bi-specifics, next-generation) and antibody drug conjugates (ADCs). The registration automates molecule uniqueness checks, generates unique identifiers, annotates relevant domains and chemical liabilities (e.g. undesired PTMs), and calculates physicochemical properties.

Sample Management: Comprehensive sample management of material batches including final products, intermediates, or reagents, such as plasmid preps or protein batches. Registration tools contain business logic for common laboratory steps of batch pooling and splitting, and single-point generation of sample handover reports (e.g. Certificate of Analysis, CoA).

Cloning and Molecular Biology: Tools for in-silico cloning automate the batch generation of new expression constructs and automated registration of new molecules based on proprietary backbone vectors and cloning strategies. This is used for antibody reformatting (e.g. from Fab to IgG), isotype switching, and to support subsequent expression system and process optimizations (e.g. exchange of signal peptides, tags).

Protein Expression and Purification: Handles all expression system information (i.e. commercial hosts, internally developed transient and stable pools; mammalian, prokaryotic, others; vector choices), process parameters in USP and DSP such as additive or tag usage, protocols and protein yields. The integrated data management platform enables investigation of specific production parameters and eliminates protein productivity bottlenecks.

Analytics and Quality Control: Flexible data model for storing, structuring, and managing all relevant analytics, assay, and QC data as well as protein production sample read-outs. The system includes importers for handling disparate data derived from analytics instruments, such as HPLC-MS, SDS-PAGE, and SEC. Typical reportable values include purity, aggregation, and endotoxin levels.

IT Infrastructure Integration: Integration with existing IT systems, such as ELNs, project management systems or small-molecule registration systems.