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Related Concept Videos

Next-generation Sequencing03:00

Next-generation Sequencing

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The first human genome sequencing project cost $2.7 billion and was declared complete in 2003, after 15 years of international cooperation and collaboration between several research teams and funding agencies. Today, with the advent of next-generation sequencing technologies, the cost and time of sequencing a human genome have dropped over 100 fold.
Next-Generation Sequencing Methods
Although all next-generation methods use different technologies, they all share a set of standard features....
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Multi-species Conserved Sequences02:51

Multi-species Conserved Sequences

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Next-generation sequencing technologies have created large genomic databases of a variety of animals and plants. Ever since the human genome project was completed, scientists studied the genome of primates, mammals, and other phylogenetically distant living beings. Such large-scale  studies have provided new insights into the evolutionary relationship between organisms.
Although the genome of each species varies greatly from each other, a few sequences are highly conserved. Such conserved...
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Sanger Sequencing01:57

Sanger Sequencing

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DNA sequencing is a fundamental technique that is routinely used in the biological sciences. This method can be applied to a range of questions at different scales - from the sequencing of a cloned DNA fragment or the study of a mutation in a gene up to whole-genome sequencing. However, despite the widespread use of sequencing today, it was not until 1977 that Fredrick Sanger and his collaborators developed the chain-termination method to decode DNA sequences. It relies on the separation of a...
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RNA-seq03:21

RNA-seq

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RNA sequencing, or RNA-Seq, is a high-throughput sequencing technology used to study the transcriptome of a cell. Transcriptomics helps to interpret the functional elements of a genome and identify the molecular constituents of an organism. Additionally, it also helps in understanding the development of an organism and the occurrence of diseases. 
Before the discovery of RNA-seq, microarray-based methods and Sanger sequencing were used for transcriptome analysis. However, while...
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Genomics02:02

Genomics

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Genomics is the science of genomes: it is the study of all the genetic material of an organism. In humans, the genome consists of information carried in 23 pairs of chromosomes in the nucleus, as well as mitochondrial DNA. In genomics, both coding and non-coding DNA is sequenced and analyzed. Genomics allows a better understanding of all living things, their evolution, and their diversity. It has a myriad of uses: for example, to build phylogenetic trees, to improve productivity and...
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Maxam-Gilbert Sequencing01:05

Maxam-Gilbert Sequencing

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In the same year as the discovery of the Sanger sequencing method, another group of scientists, Allan Maxam and Walter Gilbert, demonstrated their chemical-cleavage method for DNA sequencing. The Maxam-Gilbert method relies on using different chemicals that can cleave the DNA sequence at specific sites, the separation of resulting DNA fragments of variable size using electrophoresis, and deciphering the DNA sequence from the resulting gel bands.
Challenges of the Maxam-Gilbert Method
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Related Experiment Video

Updated: Aug 16, 2025

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
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IABS/DCVMN webinar on next generation sequencing.

Arifa S Khan1, Sebastiaan Theuns2, Laurent Mallet3

  • 1Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Biologicals : Journal of the International Association of Biological Standardization
|December 21, 2022
PubMed
Summary

Next Generation Sequencing (NGS) offers a promising alternative to traditional viral testing in biologics. Further validation is needed to establish NGS for adventitious virus detection in vaccine production.

Keywords:
Adventitious agentAdventitious virusContaminationNGSNext generation sequencingVaccine

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Area of Science:

  • Virology
  • Molecular Biology
  • Bioinformatics

Background:

  • Current viral testing methods for adventitious agents in biologics have limitations.
  • Next Generation Sequencing (NGS) presents a novel technological approach to overcome these limitations.
  • The International Alliance for Biological Standardization (IABS) and Developing Countries Vaccine Manufacturers Network (DCVMN) organized a webinar on NGS in July 2022.

Purpose of the Study:

  • To introduce the technical and bioinformatics concepts of NGS.
  • To discuss the strengths and limitations of NGS for vaccine production and development.
  • To assess the readiness of NGS to replace or supplement current viral detection assays.

Main Methods:

  • Webinar presentation covering NGS technical and bioinformatics concepts.
  • Conference discussion on the state of scientific knowledge and readiness of NGS.
  • Review of ongoing efforts for validation and establishment of NGS methods.

Main Results:

  • NGS is a promising technology for adventitious virus detection in biologics.
  • Demonstrating assay performance (sensitivity, specificity, reproducibility) is crucial for NGS adoption.
  • Laboratory and bioinformatics work are necessary for validating NGS performance.

Conclusions:

  • NGS has the potential to supplement or replace current in vivo and in vitro assays for adventitious virus testing in vaccine production.
  • Continued efforts from regulatory authorities, industry, and researchers are essential for validating and establishing NGS.
  • Further work is required to fully demonstrate and validate NGS for routine use in biologics manufacturing.