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

ABSTRACT:

Background

Unbiased deep sequencing offers the potential for improved adventitious virus screening in vaccines and biotherapeutics. Successful implementation of such assays will require appropriate control materials to confirm assay performance and sensitivity.

Methods

A common reference material containing 25 target viruses was produced and 16 laboratories were invited to process it using their preferred adventitious virus detection assay.

Results

Fifteen laboratories returned results, obtained using a wide range of wet-lab and informatics methods. Six of 25 target viruses were detected by all laboratories, with the remaining viruses detected by 4-14 laboratories. Six non-target viruses were detected by three or more laboratories.

Conclusion

The study demonstr

SUBMITTER: Mee ET 

PROVIDER: S-EPMC4823300 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature