About: Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine

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About: Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine
Creator	Gregersen, Jens-Peter Egan, William Jarrett, Ruth Novicki, Deborah Onions, David
Source	Elsevier; Medline; PMC
abstract	Abstract Cell culture-based production methods may assist in meeting increasing demand for seasonal influenza vaccines and developing production flexibility required for addressing influenza pandemics. MDCK-33016PF cells are used in propagation of a cell-based seasonal influenza vaccine (Optaflu®); but, like most continuous cell lines, can grow in immunocompromised mice to produce tumors. It is, therefore, essential that no residual cells remain within the vaccine, that cell lysates or DNA are not oncogenic, and that the cell substrate does not contain oncogenic viruses or oncogenic DNA. Multiple, redundant processes ensure the safety of influenza vaccines produced in MDCK-33016PF cells. The probability of a residual cell being present in a dose of vaccine is approximately 1 in 1034. Residual MDCK-DNA is ≤10ng per dose and the ß-propiolactone used to inactivate influenza virus results in reduction of detectable DNA to less than 200base pairs (bp). Degenerate PCR and specific PCR confirm exclusion of oncogenic viruses. The manufacturing process has been validated for its capacity to remove and inactivate viruses. We conclude that the theoretical risks arising from manufacturing seasonal influenza vaccine using MDCK-33016PF cells are reduced to levels that are effectively zero by the multiple, orthogonal processes used during production.
has issue date	2010-09-30(xsd:dateTime)
bibo:doi	10.1016/j.biologicals.2010.04.003
bibo:pmid	20537553
has license	els-covid
sha1sum (hex)	85cf0d4fd0de528e8178161a44d55112650d1058
schema:url	https://doi.org/10.1016/j.biologicals.2010.04.003
resource representing a document's title	Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine
has PubMed Central identifier	PMC7129197
has PubMed identifier	20537553
schema:publication	Biologicals
resource representing a document's body	covid:85cf0d4fd0de528e8178161a44d55112650d1058#body_text
is schema:about of	named entity 'multiple' named entity 'influenza' named entity 'DERIVED' named entity 'CELL CULTURE' named entity 'ITS' named entity 'INFLUENZA VACCINES' named entity 'METHODS' named entity 'DETECTABLE' named entity 'CAPACITY' named entity 'APPROXIMATELY' named entity 'A CELL' named entity 'GROW' named entity 'INFLUENZA' named entity 'ONCOGENIC VIRUSES' named entity 'EXCLUSION OF' named entity 'SEASONAL INFLUENZA' named entity 'BEING' named entity 'PANDEMICS' named entity 'DEVELOPING' named entity 'DEGENERATE' named entity 'CELL LINES' named entity 'INFLUENZA VACCINE' named entity 'VACCINE' named entity 'CONFIRM' named entity 'ORTHOGONAL' named entity 'VIRUSES' named entity 'PRESENT' named entity 'IMMUNOCOMPROMISED' named entity 'DNA' named entity 'REQUIRED' named entity 'REDUCED' named entity 'USING' named entity 'ZERO' named entity 'TUMORS' named entity 'PROPAGATION' named entity 'PROPIOLACTONE' named entity 'MDCK' named entity 'CONTINUOUS' named entity 'CELL' named entity 'RISKS' named entity 'MEETING' named entity 'REDUNDANT' named entity 'MANUFACTURING PROCESS' named entity 'CONTAIN' named entity 'RESIDUAL' named entity 'ADDRESSING' named entity 'INFLUENZA VACCINE' named entity 'BUT' named entity 'ENSURE' named entity 'SPECIFIC' named entity 'VALIDATED' named entity 'INCREASING' named entity 'TO REMOVE' covid:arg/85cf0d4fd0de528e8178161a44d55112650d1058 named entity 'MICE' named entity 'LESS THAN' named entity 'USED' named entity 'BASED' named entity 'INFLUENZA VIRUS' named entity 'ARISING' named entity 'SAFETY' named entity 'VALIDATION' named entity 'SUBSTRATE' named entity 'ESSENTIAL' named entity 'DOSE' named entity 'TO PRODUCE' named entity 'PCR' named entity 'CELLS' named entity '200' named entity 'DOES NOT' named entity 'CONCLUDE' named entity 'MULTIPLE' named entity 'ASSIST' named entity 'FLEXIBILITY' named entity 'PRODUCTION' named entity 'SUBSTRATE' named entity 'SAFETY'

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