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Next Generation Sequencing

Applications Tailored for Biosafety TestingNGS_flowchart

Next Generation Sequencing (NGS, also referred to as “Massively Parallel Sequencing”) is an effective biosafety testing tool for use in adventitious agent detection, virus seed stock, bacterial cell line, and expression vector identification, and cell substrate genetic stability testing.

Our expertise in NGS-based biosafety testing services allows us to provide complete genomic analysis solutions to our clients, from sample preparation and library generation through sequencing and data mining using state of the art computational and bioinformatics platforms, tools and methodologies. We routinely develop and utilize custom, proprietary algorithms to meet our client’s unique needs. Throughout this process, our biosafety experts provide sound study design, and thorough data analysis and interpretation to ensure the highest quality results.

Click here: NGS Applied to Biologic Production and Safety

Contact an expert about your NGS needs.

Adventitious Agent Detection

Regulatory authorities recommend that biopharmaceutical products and the raw materials used to produce them undergo rigorous safety testing for adventitious agents. The use of NGS for this testing enables the detection of any nucleic acid contaminant that may be present. NGS provides an additional level of biosafety assurance that can support traditional testing methods such as in vitro and PCR-based assays.

  • Can detect and identify viral, bacterial and fungal contaminants present in a sample
  • Testing can be performed on raw materials, cell banks, virus banks, culture media and bulk harvests
  • Speeds the investigation and remediation of biomanufacturing biological contamination events

Identity Testing

NGS can be used to confirm the identity of viral and bacterial seed stocks as well as expression vectors used in vaccine or gene therapy products. Such identity testing is a requirement of regulatory agencies for biologics intended for human use. NGS is a particularly cost-effective method for the rapid and comprehensive sequencing of large genomes. NGS platforms generate deep sequence coverage, enabling the confirmation of identity and the detection of even ultra-low frequency genomic variants often missed through conventional sequencing methods.

  • Provides both a targeted and non-targeted approach to identity testing
  • Variant determination and reference sequence generation
  • Discrimination of highly related strains or sub-populations

Genetic Stability Testing

Genetic stability is defined in the ICH Q5B guidance document as the characterization of an expression construct used for the production of recombinant DNA protein products in a cell system. Traditionally, a combination of approaches has been required to fully define the genetic stability of a cell line. NGS provides all of the information needed for genetic stability testing in a single run.

  • Enhances early product development, for example clonal selection and de novo cell line characterization
  • Integrated construct copy number analysis
  • Assessment of the integrity and configuration of the genomic and expressed copies of the integrated construct(s)
  • Identification of the location of the integrated construct(s) within the genome
  • Identification of sequence variants within the integrated construct(s)

Custom NGS Services

Our experts have significant experience with the design and execution of custom NGS-based experiments, each tailored to meet our client’s unique needs and requirements. Our scientists are available for consultation to design and execute the optimal study for the highest data quality, meeting regulatory guidelines.

Bioinformatics Services

Our highly experienced team of bioinformatics specialists delivers a range of bioinformatics solutions, from standard to highly customized service offerings. Examples include:

  • Complete sequence analysis/confirmatory analysis
  • Mapping and de novo assembly
  • Variant detection, including low frequency mutation identification
  • Transcriptome analysis (RNA-Seq)
  • Differential gene expression
  • Custom database creation and BLAST analysis
  • Custom algorithm development and validation
  • Cloud computing services
  • 21CFR Part11 compliant data tracking and data storage

Contact an expert about your NGS needs.

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