title: Need for new technologies for detection of adventitious agents in vaccines and other biological products.
abstract: From an industrial perspective, the conventional in vitro and in vivo assays used for detection of viral contaminants have shown their limitations, as illustrated by the unfortunate detection of porcine circovirus contamination in a licensed rotavirus vaccine. This contamination event illustrates the gaps within the existing adventitious agent strategy and the potential use of new broader molecular detection methods. This paper serves to summarize current testing approaches and challenges, along with opportunities for the use of these new technologies.
  Testing of biological products is required to ensure the safety of patients. Recently, a licensed vaccine was found to be contaminated with a virus. This contamination did not cause a safety concern to the patients; however, it highlights the need for using new testing methods to control our biological products. This paper introduces the benefits of these new tests and outlines the challenges with the current tests.
authors.affiliation: Sanofi Pasteur, Product Conception and Development, Marcy L'Etoile, France; and Laurent.Mallet@sanofipasteur.com.
authors.forename: Laurent
authors.initials: L
authors.lastname: Mallet
authors.affiliation: Sanofi Pasteur, Analytical Research and Development North America, Toronto, Ontario, Canada, Lucy.Gisonni-Lex@sanofipasteur.com.
authors.forename: Lucy
authors.initials: L
authors.lastname: Gisonni-Lex
mesh_terms: D001702:Biopharmaceutics / Q000379:methods* / Q000592:standards; D003257:Consumer Product Safety; D004279:DNA, Viral / Q000235:genetics; D004340:Drug Contamination / Q000517:prevention & control*; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D061214:Patient Safety; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D014612:Vaccines / Q000032:analysis* / Q000592:standards; D014773:Virology / Q000379:methods* / Q000592:standards; D014780:Viruses / Q000235:genetics / Q000302:isolation & purification*
chemical_list: D004279:DNA, Viral; D014612:Vaccines
keywords: Adventitious agents; Biological products; Cell substrates; Next-Generation Sequencing; Product safety; Regulatory harmonization; Viral vaccines; Virus detection assays