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BIOLOGICALS PRODUCTION

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In the effort to re-establish the vaccine production in the country, the Vaccine Self Sufficiency Project was conceptualized (see feature report). Operationally, this project will be implemented in phases. Phase 1 will establish the following units: BCG and Antivenin vaccine production plant, Quality Control Laboratory, Air handling Utilities, Power Plant, Storage and Packaging.

The BCG vaccine was included in the first phase of Biological Production Division facility because good quality BCG vaccine had been successfully produced in the past. BCG production will form the nucleus from which all other vaccines will be produced. Antivenin, specific against Philippine cobra venom, is another vaccine, which is being produced in the BPS laboratory. Antivenin will be upgraded into GMP quality in the new vaccine production facilities.

Phase 2 is the establishment of filling lines for the combination vaccine (DPT, HVB and Hib), Tetanus toxoid and anti rabies will be included in this phase. Only filling lines and separate air handling facilities will be added. Water utilities and warehouse facilities have already been established in Phase 1. The plant was subcontracted to Pharmadule of Sweden and are certified by the Swedish Food and Drug Authority in December 2000. At the final stage of re-assembly at RITM, the National Control Laboratory for Vaccines at Bureau of Food and Drugs, Department of Health, which was established to serve as the external quality control and assurance for all vaccines produced at RITM, have been involved at the outset.

© 2001 Research Institute for Tropical Medicine