title: Establishment of pandemic influenza vaccine production capacity at Bio Farma, Indonesia.
abstract: In Indonesia, avian influenza A(H5N1) virus started to spread in humans in June 2005, with an alarming case-fatality rate of more than 80%. Considering that global influenza vaccine production capacity would barely have covered 10% of the world's pandemic vaccine needs, and that countries with no production facilities or prearranged contracts would be without access to a vaccine, the Government of Indonesia embarked on a programme to increase its readiness for a future influenza pandemic. This included the domestic production of influenza vaccine, which was entrusted to Bio Farma. This health security strategy consists of developing trivalent influenza vaccine production capacity in order to be able to convert immediately to monovalent production of up to 20 million pandemic doses for the Indonesian market upon receipt of the seed strain from the World Health Organization (WHO). For this purpose, a dedicated production facility is being constructed within the Bio Farma premises in Bandung. As an initial stage of influenza vaccine development, imported seasonal influenza bulk has been formulated and filled in the Bio Farma facility. Following three consecutive batches and successful clinical trials, the product was licensed by the Indonesian National Regulatory Authority and distributed commercially for the Hajj programme in 2009. With continued support from its technology transfer partners, Bio Farma is now advancing with the development of upstream processes to produce its own bulk for seasonal and pandemic use.
authors.affiliation: PT Bio Farma (Persero), Jalan Pasteur No. 28, Bandung 40161, Indonesia. mail@biofarma.co.id
authors.forename: Mahendra
authors.initials: M
authors.lastname: Suhardono
authors.forename: Dori
authors.initials: D
authors.lastname: Ugiyadi
authors.forename: Ida
authors.initials: I
authors.lastname: Nurnaeni
authors.forename: Imelda
authors.initials: I
authors.lastname: Emelia
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D007214:Indonesia / Q000453:epidemiology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000600:supply & distribution*; D007251:Influenza, Human / Q000453:epidemiology* / Q000517:prevention & control*; D058873:Pandemics / Q000517:prevention & control; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000458:organization & administration*
chemical_list: D007252:Influenza Vaccines