Genedata Selector for Biosafety Assessment

During the production process of biopharmaceuticals, inadvertent introduction of adventitious agents (viral or microbial contamination) to a production lot can occur. Adventitious agents can be introduced in cell culture components, contaminated host cell lines, or from improper laboratory handling. Loss of production cycles due to contamination has significant financial impact for manufacturers. Therefore, accurate and efficient biosafety assessment is a crucial part of good manufacturing practices (GMP) for biological products.

Many companies are adopting next-generation sequencing as their primary method for non-specific biosafety assessment due to its broad, unbiased detection capabilities and rapid results. The use of NGS technology for contaminant detection generates massive amounts of genomic data that can be cumbersome and time-consuming to analyze. Genedata Selector enables the unbiased detection of adventitious agents in biological production processes through reliable and reproducible analysis of NGS data in a GMP compliant workflow.

Key Features of Genedata Selector for Biosafety Assessment

  • Facilitates the unbiased detection of adventitious agents in culture media components like bovine serum, cell free supernatants, host cell lines, or biological products with NGS
  • Manages host cell, viral, and microbial genome databases along with the assayed sample information
  • Allows for efficient and reproducible analyses of NGS data for specific identification of adventitious agents through automated workflows
  • Automatically generates clear and concise reports to empower confident decision making
  • Significantly reduces the time required to perform NGS data analysis, thus ensuring quick release of production lots

Genedata Selector has extensive experience in supporting customers using NGS for biosafety assessment.  We provide a broad range of validated software tools combined with scientific consulting and professional services.

Rely on a partner with 20 years of experience servicing the pharma and industrial biotech industries to give you confidence in your investigation of microbial contamination and in your decision to release your production lots to consumers.