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Next Generation Sequencing

Next generation sequencing (NGS) is a rapidly evolving method for biosafety testing, and is generally expected to become an industry standard and a regulatory compliant platform for safety evaluation. The method involves the deep sequencing of all the nucleic acids present in a biologic sample, and applying search tools and bioinformatics algorithms to identify whole or parts of adventitious agent genomes from open access databases. This broad-ranged, “open target” approach to identify all contaminants, including both known and variant microorganisms, is highly scalable, flexible and provides good analytical sensitivity and a broad range of detection. Increasingly used in conjunction with other methods, NGS is a significant improvement in biosafety testing.

NGS technologies have the capacity to sequence DNA at an unprecedented speed, requiring advanced bioinformatics tools to successfully apply the technology. Initially restricted to fundamental research, early NGS testing of a single genome took 13 years and billions of dollars. Today, NGS typically requires only a few hours or days to move from an idea to full data sets, and sequences millions of DNA fragments in parallel, thanks to the rapid advancement in technology supporting millions, even billions of reads. The NGS approach for adventitious agent testing is now comparable from both a time and cost basis compared to in vitro and in vivo tests, and has a wide variety of applications.

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Figure 1. Overview of the main steps in next generation sequencing workflow. (Petric, R.C. et al. 2015)

NGS Services at Creative Animodel
NGS is an effective biosafety testing tool for use in adventitious agent detection, identity testing, and genetic stability testing. Our expertise in NGS-based biosafety testing services and state-of-the-art computational and bioinformatics platforms allow us to provide complete genomic analysis solutions for our clients.Adventitious agent detection
Regulatory agencies recommend that biopharmaceutical raw materials and final products undergo rigorous safety testing for adventitious agents. The use of NGS enables the detection of any nucleic acid contaminant that may be present. In addition, NGS can support traditional testing methods such as in vitro and PCR-based assays.
Identity testing
The identity testing is required by regulators for biologics intended for human use. NGS can be used to rapidly identify viral banks, cell lines, and expression vectors used in biological therapy products. Based on the deep sequence coverage, NGS platforms can even identify ultra-low frequency genomic variants.
Genetic stability testing
Genetic stability of recombinant genes, such as characteristics and integrity, has to be verified through the production process in a cell system. NGS can provide all of the information needed for genetic stability testing in a single run.
Custom NGS services
Our company has deep expertise and rich experience in providing custom NGS services. Compliant with regulatory guidelines, our experienced scientists can provide optimal experimental design, execute rigorous operation, and offer high-quality data to meet your specific needs.

Creative Animodel provides a wide range of NGS based biosafety testing services for our clients. We look forward to cooperating with you in the near future.

Reference:
1. Petric, R.C.; et al. Next generation sequencing applications for breast cancer research. Clujul Medical, 2015, 88(3):278-287.

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