Process equipment will then be installed

and connected to

Process equipment will then be installed

and connected to utility and service distribution points. Following operational and performance qualification, GMP and building monitoring systems and the training of staff in all standard operating and maintenance procedures, it is estimated that the plant will be fully operational during 2012. Bio Farma has entered an arrangement with the supplier of Biken in Japan – HokoEn – for the supply of embryonated eggs. However, in order to move towards self-sufficiency in the event of a pandemic, and given Bio Farma’s extensive experience in handling specific pathogen-free eggs for measles vaccine, the company initiated the establishment of its own chicken farm within its existing 28 ha animal breeding farm in Cisarua, Lembang, ABT-199 clinical trial some 25 km from Bandung. The farm will contain a rearing house with a capacity for 16 500 hens and three production houses for 16 500 hens each, sufficient to produce >4 million eggs/year, i.e. to meet current production projections. Bio Farma will also enter into negotiations with other egg producers in Indonesia to ensure an adequate supply of clean eggs in the event of a pandemic. Construction check details of the farm is due

for completion in April 2011 and, following quality control and the importation of chickens, embryonated eggs are expected to become available during the second half of 2011. To ensure the efficiency of the technology transfer project, staffs at Bio Farma have been fully trained in the management, production and quality control techniques related to influenza vaccine, both on and off site. At the start of the influenza project at Bio Farma in August–September 2007, four staff were invited to Biken Institute in Japan for 2 weeks’ training in the formulation and quality control of seasonal influenza vaccine, including regulatory aspects. This was followed in April 2008 by a 1-week course at the National Institute for Biological Standards and Control in the United Kingdom to learn the techniques for carrying out specific assays for influenza

vaccine testing, such as single radial immunodiffusion (SRID) assays and testing for endotoxin. Also isothipendyl under the auspices of the WHO technology transfer project, Bio Farma quality control staff joined a 1-week workshop on quality assurance and GMP related to influenza vaccine at the Netherlands Vaccine Institute (NVI) in Bilthoven, the Netherlands in June 2009. The production team also visited NVI to attend a 3-week training course on influenza production and quality control. Participants learnt first-hand all aspects of the influenza vaccine production process as well as the quality control and release assays specific to individual processes such as 50% of the egg infectious dose (EID50), SRID, and tests for ovalbumin, neuraminidase, endotoxin and sucrose gradients.

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