Defining a Sample Preparation Workflow for Advanced Virus Detection and Understanding Sensitivity by Next-Generation Sequencing

@article{Wang2014DefiningAS,
  title={Defining a Sample Preparation Workflow for Advanced Virus Detection and Understanding Sensitivity by Next-Generation Sequencing},
  author={Christopher J Wang and Szi Fei Feng and Paul A. Duncan},
  journal={PDA Journal of Pharmaceutical Science and Technology},
  year={2014},
  volume={68},
  pages={579 - 588}
}
The application of next-generation sequencing (also known as deep sequencing or massively parallel sequencing) for adventitious agent detection is an evolving field that is steadily gaining acceptance in the biopharmaceutical industry. [] Key Method We describe a theoretical model to estimate the detection of a target virus in a cell lysate or viral vaccine harvest sample. We show that nuclease treatment can be used for samples that contain a high background of non-relevant nucleic acids (e.g., host cell DNA…
View on PDA
ncbi.nlm.nih.gov
5 Citations

Figures and Tables from this paper

5 Citations

Modeling an Approach To Define Sensitivity of Viral Detection in Sample Matrices—Examples with Microarray Readout

An approach to establishing the suitability of advanced nucleic-acid-based detection systems for characterization of cell substrates and production cultures is evaluated and a means by which technology users, developers, and regulators may consider the critical performance attributes of novel detection technologies is suggested.

Development of a candidate reference material for adventitious virus detection in vaccine and biologicals manufacturing by deep sequencing

Nucleic acid detection techniques for adventitious agent testing

DNA microarray and next-generation sequencing were found to be a more reliable method of screening for adventitious agents than microarray, and NGS was found to been a more reliability method for screening for Adventitious agent testing.

Reshaping cell line development and CMC strategy for fast responses to pandemic outbreak

An accelerated CMC workflow for biologics is elucidated, including using GMP‐compliant pool materials for phase I clinical trials, and selecting the final clone with product quality similar to that of phase I materials for late‐stage development and commercial production.

A molecular survey of canine respiratory viruses in New Zealand

The authors' data represent the first detection of CnPnV in New Zealand, but the role of this virus in CIRDS remains unclear, and on-going monitoring of canine respiratory pathogens by NGS would be beneficial, as it allows rapid detection of novel viruses that may be introduced to the New Zealand canine population in the future.

References

SHOWING 1-3 OF 3 REFERENCES

Modeling an Approach To Define Sensitivity of Viral Detection in Sample Matrices—Examples with Microarray Readout

An approach to establishing the suitability of advanced nucleic-acid-based detection systems for characterization of cell substrates and production cultures is evaluated and a means by which technology users, developers, and regulators may consider the critical performance attributes of novel detection technologies is suggested.

Comparison of three next-generation sequencing platforms for metagenomic sequencing and identification of pathogens in blood

Overall, the benchtop platforms perform well for identification of pathogens from a representative clinical sample, however, unlike identification, characterization of pathogens is likely to require higher titers, multiple libraries and/or multiple sequencing runs.

Evaluation of High-Throughput Sequencing for Identifying Known and Unknown Viruses in Biological Samples

For the viruses represented, or resembling those represented, in public nucleotide sequence databases, it is shown that the higher output of Illumina is associated with a much greater sensitivity, approaching that of optimized quantitative (RT-)PCRs.