Viral vaccine Laboratory has been established for QC evaluation of viral vaccines. The biologicals tested by the laboratory are:
Cell culture Rabies vaccine (CCRV): biological potency assay
The potency assay for cell culture Rabies vaccine carried out by
NIH test (the test was developed at the National Institute of Health, Bethesda, USA).The test measures the degree of protection conferred by inactivated rabies vaccine in immunized mice challenged with rabies virus.
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Quantity of sample required for testing each batch and for lot release has been calculated on the basis of tests required for complete batch testing and the quantity to be retained.This will also depend on the pack size of the vaccine available in the market.Twenty vials (1ml each; single use) which include the retained quantity are required for testing.
- For Scrutiny of protocol, the required information to be submitted by manufacturers for potency testing of Cell culture Rabies vaccine (CCRV) has been prepared and soon be available on web site.
- Any preparation of Reference Standard or sera panel activity in the laboratory :
The reference standard provided by the manufacturer M/S Chiron vaccine Pvt. Ltd. batch No. WF -3 is used in test.
- Participation in any Inter laboratory collaborative study:After full QC evaluation NIB will participate in inter laboratory collaborative study.
- Expansion of activities:NIB has expanding its activity by taking up the QC evaluation of other viral and bacterial vaccines.The biologicals taken up/ in process of taking the following vaccines/ immune globulins in the phase manner as per requirements of IP, EP/BP, USP :
- Human Rabies Immune Globulin (HRIG):The standardization of in vitro potency of anti rabies serum has been initiated.The potency testing has been carried out using the CVS.The Radial Flurescent Focus Inhibition Test (RFFIT) and invitro assay recommended by the Europeal pharmacopiea (EP)and United State Pharmacopieia ( US) shall be correlated with the invitro potency assay.The activity of further standardization of the remaining parameters is in process.
Measles Mumps Rubella vaccine (MMR)- Recombinant Hepatitis B vaccine
- Oral Polio vaccine:
- Live attenuated Measles vaccine
- Influenza vaccine
- Japanese encephalitis (inactivated mouse brain) vaccine:
Scientific links:
Name of organization/ Institute/ body-National or International
i Secretary –cum-Scientific Director,
Indian Pharmacopeia Commission,
Raj Nagar, sector 23,
Ghaziabad
Email:ipclabAvsnl.net
Drug Controller general ( I)
First Floor, CHEB Campus,
Room No. 111, FDA Bhawan,
New Kotla Road, New Delhi-110001
E-mail: dci@nb.nic.in
Manufacturers
Manufacturers of viral vaccines (Public sector):
Central Research Institute Kasauli (JEV)
Pasteur Institute of India, Coonoor (CCRV).
BIBCOL, Bulandsahar (OPV, blend)
HBPCL, Mumbai (OPV, blend)
Manufacturers of viral vaccines (Private sector):
