Next Generation DNA Sequencing Services

Through our partnership with PathoQuest, we have expanded our comprehensive portfolio of services to include Next Generation Sequencing (NGS) services to pharmaceutical and biotech companies. These services include biologics viral contamination testing and cell line characterization used in production processes of other materials used in the development of biologics.

Applications for NGS DNA Sequencing

  • Viral Safety

    Adventitious viruses can contaminate biopharmaceutical production systems and go undetected with consequent risks to the final product. Next Generation Sequencing (NGS) testing is a technique that does not require targeted primers to look for viral contamination; instead it is able to scan millions of RNA/DNA sequences concurrently. After sequences of interest are identified, bioinformatics are used to scan through them to determine matches to known viruses and potentially to identify new, unknown viruses. Confirmation testing for NGS “hits” can then be done via targeted PCR approaches.

    Our NGS-based adventitious virus testing approach uses a process called metagenomics to provide a more sensitive and comprehensive method to the identification of pathogens.

    Our advanced approach permits the identification necessary to address the specificities of each sample type such as​:

    • Cell banks (any type)​
    • Cell culture intermediates​
    • Unprocessed bulk harvest (recombinant proteins, e.g., Ab)
    • Master or working viral seeds/vectors
    • Bulk harvest
    • Drug substance or drug product
  • Genetic Stability Testing/Cell Line Characterization

    Next Generation Sequencing permits parallel sequencing of millions of DNA fragments and is now recognized as one of the most powerful and reliable tools for full genome sequencing. The combination of PathoQuest’s expertise in microbiology and virology, combined with Illumina’s state-of-the-art NGS sequencing platforms, makes us a unique solution provider to assess the safety of your cell lines and virus stocks.

    We offer sequencing on Nanopore MinIon, MiSeq, or NextSeq of STR (single tandem repeat) for DNA fingerprinting, insert, or targeted sequences comparison. For full genome sequencing we offer services on MiSeq or NextSeq systems and de novo assembly or comparison to a reference sequence in a rapid turnaround time.

    The use of NGS for these purposes allows you to run one study instead of having to perform multiple assays to achieve the same comprehensive results and is currently available on demand.

  • De-Risking the Drug Development Pipeline

    Next Generation Sequencing (NGS) metagenomic approaches also enable the testing of all biological media and other components that are used in the development of biologics from the R&D stage to the batch release of marketed products, including investigations in the case of a contamination. By including raw material testing in your viral safety package, you lower your risk of finding a contaminant later in your production processes.

Key Features of the NGS Testing Approach

  • Regulatory excellence from the R&D stage to the batch release of marketed products with  full GLP and GMP-integrated services, from sample preparation to actionable report, including review by an expert virologist or geneticist
  • Non-hypothesis driven testing
  • Robust and powerful bioinformatics tools including an automated BioIT pipeline and a secured private data center
  • Ability to identify a broad range of viruses, including still unknown viruses
  • Capacity to use one comprehensive test instead of multiple assays, saving time and money
  • A powerful substitute to animal testing and compliance assistance with the 3R’s initiative

Benefits of NGS vs. Traditional Methods

  • Accelerate your drug development by ensuring fast, comprehensive safety testing package
  • Decrease your risk of a false positive by applying the PathoQuest Next Generation Sequencing transcriptome approach
  • De-risk your drug development pipeline using a broad-range, powerful safety test
  • Metagenomics Next Generation Sequencing (NGS) Services offered by PathoQuest are fast, cost-effective, and fully integrated
  • 3R compliant

How Can We Support You?

 

Frequently Asked Questions (FAQs) About Next Generation Sequencing

  • What is High-Throughput Sequencing?

    While sequencing has traditionally been performed via a low throughput technique called Sanger sequencing, high-throughput sequencing (HTS) technologies are capable of sequencing multiple DNA molecules in parallel, enabling hundreds of millions of DNA molecules to be sequenced at the same time. High-throughput sequencing (HTS) is also known as Next Generation Sequencing (NGS).

  • What is Next Generation DNA Sequencing?

    There are many terms used to describe the technique in which millions of nucleotide sequences are deciphered simultaneously. Next generation DNA sequencing is the same as Next Generation Sequencing (NGS), massively parallel sequencing, and deep sequencing. These related terms describe a technology which has revolutionized genomic research. With Next Generation DNA Sequencing, an entire human genome can be sequenced within a single day.

  • Why Should Genome Sequencing Companies Use NGS?

    The primary reason to use Next Generation Sequencing vs. traditional methodologies is due to the decreased turnaround time that NGS offers. Furthermore, regulatory authorities are advancing support for NGS. It has the potential to replace existing in vitro/in vivo assays and molecular tests:

    • It can be used in direct testing of cells, virus stocks, etc. and Bioassay readout
    • Non-hypothesis driven
    • A broad range of detection
    • Differentiates live from inert viruses