Genedata Selector

for NGS-based Biosafety

Next generation sequencing enables key benefits for biosafety testing applications.  When used in place of (or in addition to) conventional in vitro and in vivo approaches, results can be reliable and fast, with a greater depth of information.

Applications include:

Adventitious agent detection: identification of foreign contaminants based on NGS analysis using predefined adventitious agent genomes, otherwise known as a targeted approach. An untargeted approach compares all NGS data against complete databases of known sequences.

Cell line identification: confirmation of host (i.e. CHO) cell line identity, as well as bacterial and viral seed stocks. Deep sequencing enables the detection of ultra-low genomic variants often missed by using traditional sequencing methods.

Cell bank characterization: comparing and assessing the integrity of inserted genomic elements throughout all stages of development; from early development to clone selection, and cell banking through to the production process.

Genedata Selector for NGS-based biosafety is an enterprise software platform that enables the implementation of an in-house biosafety solution including:

Genedata Selector supports an in-house solution that is:

  • Secure: all proprietary cell lines, samples and data remain in-house
  • Controlled: access to the software can be restricted and timestamped transactions support
    21 CFR part 11 compliance and integration in a cGMP environment
  • Comprehensive: an in-house solution provides you access to raw data as well as results
  • Timely: with an in-house solution, the time from sample to results is days instead of weeks

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 biopharma industry to give you confidence in your decision to release your production lots to consumers.