Results of these studies showed that the vaccine to be immunogeni

Results of these studies showed that the vaccine to be immunogenic and safe. The NADFC therefore issued marketing authorization and Bio Farma’s seasonal influenza vaccine Flubio® Libraries became the first licensed product of the WHO technology transfer initiative in June 2009. Some 165,000 doses were produced for commercial

distribution signaling pathway focusing principally on mass immunization of Hajj pilgrims. Until such time as Bio Farma is able to produce its own seasonal (and ultimately pandemic) antigen, bulk seasonal vaccine supplies will continue to be imported from Biken Institute in Japan, for which a commercial agreement has been signed. The majority of the critical equipment for the preparation of seed lots, upstream process and quality control in pilot scale has been received. In 2008, Bio Farma started the preliminary development of the upstream process for seasonal influenza vaccine, and by April 2009 had produced three batches of seasonal bulk antigen derived from A/Solomon Islands/3/2006 IVR-145 seed strain at 1 000 egg scale. A Technical

Collaboration and License Agreement was signed between Bio Farma and Biken Institute Dasatinib in vitro of Japan in December 2009 for the transfer of influenza vaccine upstream production process. This was implemented through the training of Bio Farma staff at the Biken campus and follow-up training in Indonesia (see Section 4 below). Technology transfer of concentrated bulk preparation comprises the upstream process technology and quality control of seasonal influenza vaccine, i.e. seed preparation and virus cultivation up to the inactivation processes. In July 2009, following the onset of the A(H1N1) influenza pandemic, Bio Farma switched its attention to the development of a vaccine against this novel strain and by November 2010 a total of 20 lots had been

produced (Table 1). Of the latest nine batches of A(H1N1) derived from A/California/7/2009 (H1N1)v-like NYMC 179A, the first three were used to familiarize Bio Farma operators with the process. Thanks to this experience and hands-on guidance from Biken experts, the next batches showed increasing consistency (Table 2), and it is expected that by early 2011, three consecutive and consistent batches will have been produced to be formulated as monovalent already pandemic ready-filled bulk. Within its overall influenza pandemic preparedness plan, the Indonesian Ministry of Health decided to set up a manufacturing facility for egg-based influenza vaccines against wild-type influenza virus strains. The project comprises the whole manufacturing process including bulk antigen production, formulation, filling, laboratory quality control facilities, as well as an independent chicken farm to produce embryonated eggs. Significant progress had made in the physical execution of the BSL3+ building within the Bio Farma complex in Bandung.

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