Genedata Biologics

Genedata Biologics® is an enterprise software platform purpose-built for the end-to-end discovery and development of biotherapeutics. It supports a broad range of modalities — including bispecific antibodies, ADCs, TCRs, CAR-T cells, AAVs, vaccines, RNA therapeutics, and novel scaffolds — making it the industry's most widely adopted solution for biologics R&D. The platform is designed for biopharma companies, biotechs, CROs, and CRDMOs of all sizes, from single-group installations to enterprise-wide deployments.

By acting as a central data backbone, Genedata Biologics integrates all R&D processes from library design and immunizations through screening, protein engineering, expression, purification, analytics, and candidate developability assessments. Its scalable, modular architecture automates routine tasks, eliminates data silos, and empowers scientists to focus on innovation. Customers report over 50% gains in efficiency and improved data quality as a result of adopting the platform.

Supported Therapeutic Modalities

• Bispecific antibodies: Identifies optimal antigen binder combinations and formats, enabling systematic design, cloning, and testing of large panels of bi- and multi-specific antibodies including knobs-into-holes (KinH), Fab-scFv, IgG-scFv, DuoBody, DVD-Ig, tandem-scFv-Fc, and parametric variants such as linkers, V-domain order, and Fc.
• Cell therapies (CARs/TCRs): Provides purpose-built tools for designing and evaluating large panels of cell-based therapeutic modalities, supporting CAR-T cells, TCR technologies, and antibody TCR-mimetics such as dsTCR, TCR-scFv, and bispecific TCRs, with direct integration to laboratory equipment for full automation.
• Gene therapy (AAVs): Supports the entire workflow from serotype optimization and viral vector design to virus packaging, purification, and testing, tracking all samples and associated data including custom vectors, packaging plasmids, cell lysates, purified virus batches, titers, and assay results such as empty-to-full capsid ratios across AAV, adenovirus, and retrovirus vectors.
• ADCs: Registers and tracks large panels of ADC candidates while managing linker and payload data in a single integrated platform, covering antibody screening and engineering through expression, purification, drug conjugation, and reporting of ADC metrics such as DAR, drug distribution, and homogeneity.
• Vaccines: Streamlines novel vaccine discovery including emerging technologies such as synthetic self-amplifying mRNA, enabling faster development through cell-free processes and rapid antigen production alongside traditional vaccine R&D.
• RNA therapeutics: Supports end-to-end design and development of RNA therapeutics and vaccines, registering, testing, and evaluating nucleic acid-based candidates at every stage, covering RNA/DNA optimization for effectiveness and stability alongside advanced screening workflows for formulation development and functional characterization.
• B-cell-derived antibodies: Tracks animal and immunization data and registers molecules, samples, QC, and functional assay results in a centralized platform, managing ELISA, FACS, and SPR experiments and enabling integrated analysis of molecular sequences and functional performance when combined with V-region sequencing data.
• Developability assessment: Systematically assesses each candidate's risk profile and critical quality attributes (CQA), flags potential issues during expression and purification, and evaluates biophysical and biochemical properties to identify the most promising candidates for development.

Core Platform Capabilities

• High-throughput screening: Captures, integrates, processes, and interprets selection and screening data from diverse discovery technologies including phage and yeast display, B-cell cloning, and hybridoma, with built-in sample tracking and integrated plate management for antibodies, bi- and multi-specifics, fusion proteins, TCRs, CAR-Ts, and other modalities.
• Protein engineering and optimization: Supports generation of combinatorial libraries from known molecular building blocks and simultaneous optimization of binding affinity, cross-reactivity, stability, and expressibility, with advanced tools for affinity maturation, site-directed mutagenesis, germlining, humanization, reformatting, and isotype switching.
• Protein production and quality control: Tracks and validates each step from initial protein definition to final characterized samples, aggregating analytical characterization and QC data — including LC-MS, SEC, HIC, endotoxin levels, glycosylation profiles, and in vivo assay results — and automatically generating Certificates of Analysis (CoAs) and other reports.
• Request management: Supports the full lifecycle of task scheduling, managing request submission and tracking from initiation through completion, facilitating intra- and intergroup communication, and centrally documenting request progress in real time.
• Sample management: Provides centralized inventory control, sample tracking, and workflow automation for cell banks, plasmids, proteins, and complex mixtures, with end-to-end traceability linking samples to analytics, assay results, and QC data, supported by automated storage management, real-time occupancy dashboards, and barcode-based identification.

Key Platform Benefits

• Increased research efficiency: Automates repetitive tasks including cloning, screening, expression, purification, data upload, processing, and reporting, with direct integration to lab instruments and robotics enabling true high-throughput workflows.
• Streamlined cross-team collaboration: Centralizes experimental data, protocols, and results in a shared digital workspace accessible to scientists, analysts, and project managers across departments, sites, and external partners such as CROs.
• Accelerated time to market: Eliminates bottlenecks in data processing and workflow execution, aggregates and links experimental data across workflows to reduce decision time, and enables rapid iteration and scale-up of promising candidates.
• Risk mitigation and compliance support: Provides built-in audit trails, data validation, and regulatory documentation tools to support compliance with industry standards, ensure reproducible results, and minimize delays caused by quality or regulatory issues.
• AI/ML and data science readiness: Delivers structured and organized data that enables data science, predictive modelling, and AI/ML projects to optimize the clinical effectiveness of medicines.

Genedata Biologics features a flexible, modular architecture that supports customization to align workflows with diverse therapeutic pipelines and organizational requirements. It integrates seamlessly with existing laboratory systems and instruments, supports collaboration across multiple sites and external partners, and scales from individual research groups to enterprise-wide deployments across global biopharma organizations.