JAIVAC-1 ([PfMSP1-19 + PfF2 /EBA175] in the E. coli system)

Inventor: Dr Chetan Chitnis (ICGEB, New-Delhi, India)
Product Leader: Shams el Arifeen (ICGEB, New-Delhi, India), Manufacturer: Bahrat Biotech, (Hydebarad, India, http://www.bharatbiotech.com/)

A contract has been signed with the International Centre for Genetic Engineering and Biotechnology, New Delhi, India for the product development and GMP production of the captioned vaccine, which is being undertaken by Bharat Biotech International Limited in Hyderabad, being a GMP certified production facility. For this purpose a sub-contract has been signed between International Centre for Genetic Engineering and Biotechnology and Bharat Biotech International Limited, with the acceptance of EMVI, after a satisfactory audit was carried out on Bharat Biotech International Limited. Production of three consistency batches was completed in December 2007, and pre-clinical toxicology studies are expected to start in May 2008. A Phase Ia clinical trial is planned for the fourth quarter 2008 in Mumbai, and an audit of potential clinical trial sites will be carried out in May 2008.