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Digitalizing Cell & Gene Therapy (CGT) R&D

What makes developing recombinant Adeno-Associated Viruses (rAAVs), Chimeric Antigen Receptor T Cells (CAR-Ts), enhanced Natural Killer Cells (iNKs), or modified T-cell receptors (TCRs) so challenging? The need to streamline design, generation, and testing of these complicated modalities. The vast amount of complex data that needs to stored, analyzed, and shared across the entire R&D process. The need for data traceability and data protection.

This is where Genedata comes in.

 

Faster Discovery of Novel CGTs

  • Facilitates structured data entry along the entire CGT discovery workflow (using the FAIR principles)
  • Systematically screens, engineers, produces, tests, and validates large panels of CGT modalities (e.g., recombinant virus plasmids, receptor clones, or modified cell lines)
  • Integrates all obtained information including the specificity, efficacy, safety, stability, manufacturability and developability parameters for each candidate to facilitate efficient selection of lead molecules, recombinant viruses, or cell lines
  • Automates sample handling and testing procedures by directly integrating with laboratory equipment
More About CGT Discovery

CGT Bioprocess Development

  • Supports bioprocess development for all biotherapeutic modalities including proteins, adoptive cells, recombinant viruses, and RNAs
  • Establishes next-generation biomanufacturing processes across cell line development, upstream processing, downstream processing, formulation, and analytics development
  • Includes thorough tracking and rigorous characterization of the relationship between critical quality attributes and critical process parameters
  • Simplifies analytical development through a centralized approach to capturing and analyzing data from all instruments and assays to assess process parameters and product quality
  • Integrates laboratory devices (e.g., bioreactors, chromatography skids, and liquid handling systems) for efficient data transfer and automation
More About CGT Development

CGT Product Characterization

  • Facilitates streamlined quality monitoring of diverse products from small oligonucleotides to recombinant viruses
  • Tracks and manages all samples and associated data such as customized vectors, packaging plasmids, cell lysates, purified virus batches and their sequences
  • Characterizes diverse viral delivery systems including adeno-associated virus (AAV), adenovirus, and retrovirus vectors
  • Facilitates virus analysis and molecular diagnostics using mass spectrometry (MS)
More About Characterization

CGT Biosafety & Quality Control

  • Accelerates biosafety profiling of cells and viral products through NGS-based detection of adventitious agents with DNA- and RNA-seq
  • Automates sequence integrity analysis of lentiviral or AAV vectors and their payloads
  • Enables cell type potency, heterogeneity, and stability testing for efficient CAR-T cell therapy (e.g., via single-cell RNA sequencing)
  • Applies automated NGS-based workflows to validate the correct insertion of genes into the host genome (e.g., Target Locus Analysis)
  • Performs efficient and automated critical quality control testing for clinical trial and market authorization
More About Biosafety

Clinical & Translational Research

  • Facilitates novel insights by enabling seamless integration, advanced performant analytics, and sophisticated visualization of clinical and translational data
  • Characterizes patient and donor profiles at molecular, immune, and clinical levels to develop more efficacious and safer CGTs and design smarter, innovative, and more focused clinical trials
  • Supports the discovery and validation of effective biomarkers of toxicity, efficacy, or risk of relapse
  • Enables tracking of patient-specific data before and after the administration of CGTs to anticipate and prevent adverse effects, ensure safety, and maximum therapeutic benefits
  • Leverages RWE to monitor patients’ health and long-term treatment benefits
More About Translational R&D

Supporting Our Customers to Advance CGT R&D

Immatics streamlines CGT processes with Genedata

Immatics streamlines CGT processes with Genedata

"The Genedata platform has provided efficiency gains on many fronts, eliminated redundancies in our daily work, and decreased our overall ongoing operating costs." Sebastian Bunk, Ph.D., Senior Director TCR Bispecifics Pipeline, Immatics. 

How Mink Therapeutics Streamlines iNKT Cell Therapy Research and Development

Efficiency Gains in Cell Therapy Discovery

"Given their track-record of success, Genedata’s platform was the clear choice to support and integrate our full cell therapy discovery and development efforts.” Marc Van Dijk, Ph.D., Chief Technology Officer

Encoded Therapeutics Partners with Genedata to Accelerate AAV-Based Gene Therapy Development

Accelerating AAV-Based Gene Therapy Development

“Leveraging Genedata’s capabilities will enable us to continue scaling Encoded’s process development capabilities to drive growth and value in gene therapy." Martin Moorhead, Ph.D., Chief Technology Officer

Accelerating Development of TCRs and Bispecifics

Accelerating Development of TCRs and Bispecifics

“Genedata Biologics is a perfect fit for our approach, because… we anticipate that the platform will be able to handle our bispecific engineering and TCR discovery and optimization workflows without any customization.” Jonah Rainey, Ph.D., Head of Antibody Therapeutics

Genedata streamlines and digitalizes the entire CGT R&D workflow, directly integrates with lab equipment to automate sample handling and testing and provides a central database across the organization.

Customer Stories