Genedata Biologics

Architecture

Genedata Biologics™ is a web application based on an Oracle® relational database infrastructure. It has been designed and optimized for processing, storing, and querying large and complex data volumes, and specifically for the handling of large numbers of samples and biomolecular sequence data. As an open system, it enables seamless interfacing and integration with existing corporate IT infrastructures. Genedata Biologics comes with significant built-in business logic and works out-of-the box in its default configuration. The system can be configured to support corporate-specific variants of the biologics R&D workflows such as handling of proprietary libraries, next-generation antibody formats, special cloning strategies, or custom molecule or sample nomenclature.

Built on a Relational Database
Foundation for structured data storage & querying

The Genedata Biologics database stores all biologics molecules and samples, together with relevant assay and analytics data. This includes raw and aggregated data imported from instruments (e.g., screening readers, sequencing instruments), experimental protocols (e.g., panning or immunization strategies) and batch information (e.g., plasmid or protein material batches), and all relevant master data (e.g., backbone vector templates, protocol templates). The database distinguishes accurately between molecule and material space and identifies molecules based on various criteria, including their DNA and protein sequences, complexation, and modifications such as PEGylation patterns or drug conjugations (ADC). The molecule database is the foundation of the Genedata Biologics registration engine that employs uniqueness checks on all registered molecules, such as therapeutic antibody and protein molecules, as well as related molecules, such as tool proteins (e.g., antigens) or vectors. All material registration is linked to the relevant molecular entity and can be traced back to experimental protocols (e.g., expression or purification protocols, used cell lines, or vector maps). This concept is the bridge to the built-in inventory management for biomaterial logistics and storage.

User Interface
Interactive registration, query, analysis, and reporting interfaces

As a web application, Genedata Biologics can be easily accessed by any client computer connected to the company’s intranet in a standard web browser. It provides an easy-to-use interface for data registration, querying, analyzing, and reporting. In addition, the Genedata Biologics user interface includes a wealth of interactive tools for in-depth exploration of complex data sets (e.g., large DNA or protein sequence sets, complex screening campaigns). The User Interface enables the direct identification and investigation of critical features such as antibody CDR structures and mutations across a large set of engineered molecule variants. Bulk upload facilities enable the import and processing of large data quantities, e.g., for bulk vector generation, antibody reformatting, or analytics result reporting. Specialized wizards support users in registering, interpreting, and reporting data. The system provides diverse data export facilities that enable direct reporting in Excel, PDF, or raw data file formats.

Instrument Integration Interfaces
Direct integration with laboratory equipment

Genedata Biologics comes with dedicated interfaces for integrating with laboratory instruments, such as assay readers, liquid handling systems, pipetting robots, colony pickers, and other robotics and laboratory automation equipment. This direct integration enables the automated import of raw, instrument-generated data and eliminates laborious and error-prone data handling. Genedata Biologics also supports two-way integration setups, producing specific instrument-readable control files for operating lab instruments. This is particularly useful for steering pipetting robots and other related plating operations, such as plate re-arraying, re-formatting, or cherry picking. The instrument integration framework, referred to as the Genedata Biologics Adapter Interfaces, enables flexible and transparent integration of diverse instrument types. Not only can Genedata Biologics be connected to different screening instruments such as ELISA, FACS, FMAT, or Biacore, but the system can even be configured to work with new or proprietary data exchange formats.

Integration with Corporate IT Systems
Comprehensive Application Programming Interfaces (APIs)

Genedata Biologics provides a rich set of APIs for straightforward integration with existing IT infrastructure, such as corporate data warehouses, request management systems, LIMSs, ELNs, or project management systems. Genedata Biologics can also integrate with and complement existing small-molecule registration systems by adhering to corporate ID nomenclature standards and enabling a shared corporate ID space for large and small molecules. In addition, dedicated APIs allow the use of corporate project IDs and other contextual information provided by central IT systems. Customers may use the platform’s plug-in interfaces to integrate their own tools with Genedata Biologics. API implementations are centrally maintained for easy distribution and maintenance. The system also integrates on a desktop scale using off-the-shelf adapters for integration with standard lab tools like Vector NTI. Complimentary Genedata tools can be added for statistical analysis, assay quality control and hit picking, and mass spectrometry data processing and analysis.