Sydney, Jan 23, 2008 AEST (ABN Newswire) - SciGen Limited (ASX: SIE) announces that it has been awarded the GMP certification of its manufacturing facility in Rehovot, Israel where its third generation hepatitis B vaccine Sci B Vac is manufactured. This comes after having successfully implemented and complied with all the requirements as specified by the World Health Organisation (WHO) and the Ministry of Health of Israel.
GMP certification is a prerequisite for the renewal of health registration in those countries where Sci B Vac was previously registered prior to the change of manufacturing site and the start of health regulatory submissions in all parts of the world including the EMEA in Europe, the FDA in the USA an other major health regulatory agencies.
About Sci B Vac:
Sci B Vac a third generation Hepatitis B Vaccine derived from mammalian cell (CHO Cell) was found to be highly immunogenic and confers high and early seroprotection. Sci B Vac has all three epitopes of the Hepatitis B Virus resulting in a rapid onset of action and greater coverage. Sci B Vac has a high degree of anti-virus response, it stimulate a special T Cell response, overcome genetic non-responsiveness and elicit pre-S directed antibody response. It was found to be especially useful in the immunization of people that did not respond to conventional present day hepatitis B vaccine also known as nonresponders.
Contact
Further information:
Investor Relations
Ms. Maria Aroyan
SciGen Australia
+61 2 9485 1800
email: mariaaroyan@scigen.com.au
Saul Mashaal
Chairman, Founder & CEO
SciGen Ltd.
+ 61 2 9485 1800
+65 9630 5691 (Mobile)
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