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SciGen Limited (ASX:SCI) Awarded Good Manufacturing Practices (GMP) Certification for Sci B Vac
Sydney, Jan 23, 2008 (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.
About SCIGEN LIMITED
SciGen Ltd is a biopharmaceutical company involved in commercializing later stage research. It co-develops and markets biopharmaceutical products for human healthcare. SciGen focuses in the areas of gastroenterology, endocrinology and immunology. Its product portfolio includes vaccines and therapeutics.
SciGen acquires rights to manufacture, distribute and market biopharmaceutical products under exclusive licensing arrangements. SciGen's portfolio currently includes proprietary biotechnology-derived products, and Biosimilar products, which allow for faster entry into the market, as Biosimilar products have undergone much of the clinical development and trials required to bring drugs to market. This minimizes the risks associated with early stage product development. SciGen currently undertakes R&D activities in collaboration with strategic partners and institutions.
SciGen's competitive advantage is in identifying research with commercial potential at an early stage to which it adds its expertise in clinical development, gaining regulatory approval and bringing products to market. SciGen is a Singaporean biotechnology company, established in 1988 and listed on the Australian Stock Exchange (ASX code SIE). SciGen is headquartered in Singapore, with subsidiary companies in the USA, Australia, S. Korea, Hong Kong, Philippines, Vietnam, Israel and India, a Joint Venture in China, commercial partners in Europe and collaborative partners in the USA and the Netherlands.
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