Accurate and Efficient NGS-Based Biosafety Testing
Genedata Selector® is an end-to-end solution for NGS-based biosafety applications. By automating data processing, analysis, and reporting, organizations can accelerate data-informed decision-making for faster and safer biotherapeutics development.
Detect Adventitious Agents
NGS provides an unbiased approach of assessing the presence of adventitious agents. It allows the detection of all organisms and is suitable for testing starting materials, unprocessed bulk harvest, and the final product.
Added benefits of performing biosafety testing with Genedata Selector® include the assessment of cell bank stability and confirmation of product sequence integrity with mutation profiling.
Confirm Sequence Integrity
Genedata Selector empowers scientists to assess the safety and integrity of biopharmaceutical products with mutation profiling. Perform automated variant detection against any reference genome or construct. Bring your analysis inhouse and protect any IP, rather than outsourcing to service providers.
Assess Cell Bank Stability and Integrity
Identify detrimental mutations early and replace lengthy assays with innovative techniques for immediate results. For example, single-cell RNA-Seq allows early detection of heterogeneous cell banks and undesired products to avoid future high costs.
GMP Regulated Environment Ready
Genedata Selector can be readily integrated into cGMP environments to provide 21 CFR part 11-compliant reports to regulatory affairs. In addition, the software provides full documentation, controlled user access, and timestamped transaction records for compliant operation.
10 Steps to Implement an NGS-Based Biosafety Assay In-House