Genedata, a leading provider of advanced software solutions for drug discovery and life science research, today announced that within its first year on the market, Genedata Biologics has been adopted by several leading pharmaceutical and biotech companies as their biotherapeutics R&D data management platform. Genedata Biologics' rapid adoption is attributed to its unique built-in domain knowledge that addresses key requirements of the biopharmaceutical discovery and development process, which is fundamentally different from the classic small-molecule-based drug discovery process. Genedata cites that more than 25% of the leading pharmaceutical companies have already licensed Genedata Biologics, a first-in-class, end-to-end solution for biologics R&D. Covering the full antibody screening, protein engineering, and biologics production process.
"The pharmaceutical industry is going through a seismic shift from small-molecule, chemical drug discovery to large-molecule, biological drug discovery," said Dr. Othmar Pfannes, CEO of Genedata. "This industry shift is analogous to the differences in building a single-family home to building a 1,000-foot office building," continued Dr. Pfannes. "The processes and technologies used for building a small home don't translate to large-scale construction projects. Similarly, software that supported chemical-based drug discovery cannot be repurposed to support novel and complex biologics processes. Genedata Biologics is a first-in-class platform dedicated to support the full biologics R&D process."
Tailored for Large-molecule R&D Requirements
While biologics R&D has matured in recent years, the underlying discovery and development process differs substantially from small-molecule R&D, posing unique challenges for pharma and biotech companies. Unlike classic small-molecule drugs, biologics are very large molecules with high molecular complexity. For example, a therapeutic antibody contains more than 25,000 atoms while a small molecule such as aspirin consists of only 21 atoms. Large biological molecules tend to be sensitive to production-process changes and can only be produced by living systems (e.g. mammalian cell cultures), which requires extremely complex and costly biotechnological processes. Specialized groups, focused on specific tasks and technologies, collaborate along the R&D workflow, which results in multiple sample and data handovers (e.g. screening, engineering, cloning, cell line development, expression, purification, and analytics). Scientists must be able to access all relevant sequence or assay information as well as analytics produced by groups working upstream. Genedata Biologics enables easy sharing of such information and helps eliminate data handling errors, tasks which can no longer be handled manually or by sharing spreadsheets.
"We see our customers - specifically large pharmas and biotechs - building up new capabilities or extending their current biopharmaceutical R&D processes. Consequently, they need a way to manage their newly established processes with the ability to annotate, track, and handle all resulting biologics molecules and samples," noted Dr. Pfannes. "Managing all this valuable data in one dedicated and integrated system is important from an IP perspective. Additionally, it streamlines the daily logistics processes in today's expansive biologics R&D groups, often comprised of hundreds of scientists and engineers, plus external partners and CROs."
Genedata Biologics provides comprehensive functionality for antibody screening, protein engineering, and biologics production. The platform integrates data management capabilities for managing biologics samples, molecules, assay and analytic data, by supporting:
- High-throughput processes for fully automated workflows via direct integration with lab automation and robotics, and tools for processing vast amounts of screening and process data.
- Standardized lab processes for more efficient, faster and less manual data handling and processing (e.g. in-silico cloning enabling large-scale cloning campaigns, eliminating cut-and-paste errors in manual cloning).
- Division-of-labor processes with centralized biologics registration and integrated workflow-support tools, which advance collaborative work among specialized biologics R&D groups. Every synthesized biologics drug candidate is accessible, editable, and transferrable among scientists and sites.