In
vitro Adventitious Virus Assays
Manufacturers of biopharmaceutical products
derived from cell lines of human or animal origin are required to
test their products at appropriate stages of production for the
absence of contaminating infectious viruses. Such testing is required
on master cell banks, working cell banks, cells at the limit of
in vitro cell age, and unprocessed bulk harvest material. Similar
testing is also required for virus vector and vaccine seed stocks,
although there may be difficulties in detecting contaminating viruses
in the presence of a live virus vector, and a customised approach
to testing may be required for such products. (ICH Q5A; FDA PTC
1993; Ph.Eur. 2.6.16).
In
vitro assays involve inoculating a test sample onto various indicator
cell lines, capable of detecting a wide range of human and relevant
animal viruses. The choice of indicator cell lines depends on the
species of origin of the cell bank to be tested (or cell line used
to produce the virus/vector), as well as the history of the cell
line, and should reflect the virus contaminants that could possibly
be present. In general, a minimum of three cell lines is required,
including a human diploid cell line, a monkey kidney cell line,
and a cell line of the same species and tissue type as that used
in the production of the manufacturers’ product. The assays
are designed to detect both cytopathic and haemadsorbing viruses.
The
following validated in vitro assays for the characterisation of
products derived from rodent or human cell lines will be released
early in 2008.
- 14
day invitro assays using a customised combination of cell lines
MRC-5, Vero, CHO-K1, 293, NS0, HeLa
- 28
day invitro assays using a customised combination of cell lines
MRC-5, Vero, CHO-K1, 293, NS0, HeLa
Indicator
lines suitable for use in the testing of other products, or to extend
the host range of the indicator panel, will become available over
2008, and may be available on request. We are able to design complex
and customised assays to meet specific product requirements.
Click here for literature references.
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