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The Division of Virology and the laboratory was instrumental in writing the EP and OMCL guidelines for Polio Vaccines (live attenuated / inactivated).
NIBSC is involved in PTS of D antigen for EDQM.
The laboratory provides extensive training to OMCL and manufacturers for both OPV testing and IPV testing.
NIBSC is involved in all aspects of Polio Vaccine Testing. This is divided into 3 areas: Live attenuated Monovalent bulk vaccine, Live attenuated Oral Polio Vaccine and Inactivated Polio Vaccine.
The live attenuated vaccine comes as a monovalent oral polio vaccine (mOVP), a bivalent oral polio vaccine (BiOPV) and a Trivalent oral polio vaccine (TOPV).
There are 3 serotypes of poliovirus which make up a trivalent OPV and these are quantified and identified by an infectivity assay. The potency and thermal stability testing is also carried out at NIBSC.
Oral Poliovirus Vaccine (OPV) is assayed for batch release by in vitro tests. Although OPV is not currently used within the UK, NIBSC tests OPV for other Official Medicine Control Laboratories (OMCL), manufacturers and WHO.
OPV Testing is carried out as per Ph Eur monograph 04/2008:0215.
This is a combination vaccine. The IPV component is currently batch released by NIBSC and is tested for D antigen units by ELISA method, and for potency.
IPV Testing is carried out as per Ph Eur monograph 01/2009:0214,
The MAPREC assay is an in vitro molecular method used to determine the proportion of a single base mutation at a given point within the vaccine viral RNA. If the calculated value of the mutation at this site is greater than acceptable values, the vaccine will fail the MAPREC test.
(European Pharmacopoeia 5th edition (2006) Vaccines for human use, Poliomyelitis vaccine - oral 01-2006:0215).