Background: In 2006, Center for research and production of vaccines and biologicals \ufffd?Ha Noi produced 10 million doses of poliomyelitis vaccine met quality standard which given by World Health Organization (WHO). The monkeys for vaccine production were selected and monkey kidney cells were tested arcording to the WHO requirements (the strong moykeys with no adventitous agents). Objectives: To assess the rates of mokeys (at the Reu island in Quang Ninh province) with no adventitous agent infection and the cells using to produce type 1 poliomyelitis vaccine in 2006. Subjects and method: The study was performed by using microneutralization technique on 39 Macaca mulatta mokeys with weights were 1.5 to 2.5 kg. Results: 11 out of 39 monkeys (28,21%) are negative to SIV, SV40, poliomyelitis viruses, foamy virus as well as tuberculin test. 100% lots of primary monkey kidney cells culture produced in 2006 are free from adventitous agents arcording to the WHO requirements. Conclusion: Center for research and production of vaccines and biologicals - Ha Noi implemented strictly under the WHO guidelines on selection of monkeys and monkey kidney cells for OPV production from Sabin strains.
Poliovirus Vaccine ; Oral ; Macaca mulatta ; Haplorhini

Background: Trivalent poliomyelitis vaccine was produced from strains which had been supported by Japan. One of the standards of vaccine quality required by WHO is potency and thermostability. Follow that potency at 370C and within 48 hours is not less effective than potency at -200C exceedingly 0,5 lgCCID50. Objectives: To assess the potency of Trivalent poliomyelitis vaccine and the thermostability of mokey vaccine preserved at 370C within 48 hours. Subjects and method: 12 lots of trivalent poliomyelitis vaccine (included 3 types) produced in January 2007 were evaluated by microneutralization technique. Results: Potency of 12 type I lots were all 106,0 CCID50/0,1ml and the disparity of potency at two temperatures were all < 0,5 lgCCID50/0,1ml. Potency of 12 type II lots were all 105,0 CCID50/0,1ml and the disparity of potency at two temperatures were all < 0,5 lgCCID50/0,1ml. Potency of 12 type III lots were all 105,5 CCID50/0,1ml and the disparity of potency at two temperatures were all < 0,5 lgCCID50/0,1ml. Conclusion: 12 final poliovaccine lots produced in Center for research and production of vaccines and biologicals \ufffd?Ha Noi in 2007 met WHO requirements for potency and thermostability.
Poliomyelitis ; Nonpoliovirus ; Poliovirus Vaccines/ therapeutic use ; Oliomyelitis/ immunology ; epidemiology

Background: \r\n', u'Chicken embryo cell was the most effective fibroblast cell line for producing the attenuated measles vaccines. Many countries as Japan, in Kitasato, an attenuated virus derived from the Edmonston virulent strain adapted in chick embryo cells, it was call AIK- C strain, and used for measles vaccine production. In Vietnam, the POLYVAC have applied the Kitasato institute\u2019s technology into measles vaccines production. The Valo SPF egg (Lohmann-Germany) was used in the chick embryo culture \r\n', u'Objectives: \r\n', u'To study the inoculation, and clone of the human AIK-C strain in the chick embryo in order to achieve a high yield of virus for measles vaccine production \r\n', u'Subjects and method:\r\n', u'Suitablecells (AIK- C Strain, an attenuated virus derived from the Edmonston virulent strain, chicken embryo cell cultured from SPF egg Valo Germany) are selected. Then methods as inoculating and culturinglive viruses on the chicken embryo cell are applied.\r\n', u'Results:\r\n', u'After 9 days for infection, viruses which were observed via microscope, propagated and in infectious clone by the measles virus.\r\n', u'Conclusion: \r\n', u'Many tests for propagation of AIK measles virus in chicken embryo cell cuture derived from Valo SPF egg (Germany) showed that chicken embryo cell culture from Valo SPF egg (Germany) is appropriated fro AIK- C measles vaccine production in Vietnam.\r\n', u'
Measles virus ;

Background: Rota vaccine is used to prevent diarrhea in children under 5 years old. Two vaccines are being used in developed countries: Rotarix (GSK) and RotaTeq (Merk). Rotarix vaccine was produced from master seed G1P8 and RotaTeq vaccine was from the coordination of human rotavirus strains G1, G2, G3, G4 and cow rotavirus strain.Thanks to the helps of WHO, Ministry of Health and Ministry of Science and Technology, Center for research and production of vaccines and biologicals \ufffd?Ha Noi made study of creating rotavirus master seed G1P4 for Rota vaccine production in Vietnam. Objectives: To evaluate the safety and potency of rotavirus master seed G1P4 in the laboratory and experimental animals. Subjects and method: Rotavirus master seed G1P4 (2001019210) lot 1 (MS-P5) and lot 2 (MS-P5) produced in 2005, preserved at -800C were determined potency by Immunofluorescence (IF) method and tested for safety on rabits and rats. Results:2 lots of Rotavirus master seed G1P4 that had been produced in Center for research and production of vaccines and biologicals \ufffd?Ha Noi had high titre and safety in the laboratory and experimental animals. Conclusion: The result was the basis of Rota vaccine production in Vietnam.
Rotavirus/ diagnostic use ; Rotavirus Vaccines/ isolation & ; purification ; contraindications

Trypsinization method in our modification was harvested high yields of dissociated cells. The total of cells is obtained 19.47 X 108 per pair of monkey kidney weighted 10 gram. Whereas rate of available cell reach 83.9% and rate of single cell and small group (<5 cells) collected was about 90%.
Trypsin ; Haplorhini ; Kidney ; Cells

Chromosomes of 45 samples of fetal monkey kidney cells from primitive to 9th passages was examined. Results showed the quantity of 2n = 42 chromosome reached 89,86-96%. The polyploidy phenomenon including internal polyploidy trended to increase from the 4th passage and the most number of chromosomes was obtained from 6th to 9th passage. In every passage, both numeral mutation and aberration were at normal range
Chromosomes ; cells ; Haplorhini ; Kidney

Background: Good Manufacturing Practice (GMP) is a important part of quality assurance (QA). Implementation of GMP request to establish the documentation system and should be reviewed as well as evaluated strictly. Documentation is important because it helps the competent person make decisions whether to finish the product or not and it is used as a base for inspection. In the year of 2006, 100% OPV production line in Center for research and production of vaccines and biologicals (POLYVAC) had established the document system. Objectives: To evaluate of the documentation for OPV production in the year of 2006 in POLYVAC. Subjects and method: Documentation for OPV production in 2006 were evaluated by standard operating procedure (SOP) (recommended by WHO). The standards included blank space; erase; code and unit of measurement; revision; no signage and others. Results and Conclusion: Documentation is different between departments. Onlymonkey ranch in Reu island applied 100% SOP. 776 errors were found. Among them blank space (32.2%), erase (27%), code and unit of measurement (21%), revision (5%), no signage (12%) and others (3.6%). The results were the basis of promoting implementation of GMP in vaccine manufacturing in POLYVAC.
Poliovirus Vaccine ; Oral/ administration & ; dosage

Background: Measles vaccine was the only vaccine in the expanded vaccination program still must be imported. Center for research and production of vaccines and biologicals \ufffd?Ha Noi was conducting the first stages of measles vaccine manufacturing technology transfer from the Kitasato Institute in Japan. The Center received semi-finished vaccine to set up finished vaccine production process as well as the testing process. Potency test and its consistency is very essential in quality control. Objectives: In order to identify standard potency assessment methods and potency of 13 lots of finished measles vaccine produced in Viet Nam from imported semi-finished products. Subjects and method: 13 lots of the finished vaccine were determined potency by plaque method based on 13 samples of semi-finished vaccine and the standard sample M16-6 had potency from 4.2 to 4.6 lg PFU/0.5 ml provided by the Kitasato Institute. Results: The result of 13 lots show that the reduction of potency during freeze-drying is within the range (0-0.76 lg); and 4 last consecutive lots are met WHO criteria on heat stability. Conclusion: This shows that the measles vaccine freeze-drying process in Vietnam was officially set up to use for the measles vaccine production in 2007.
Measles Vaccine/ diagnostic use

Background: Rota vaccine is used to prevent diarrhea in children under 5 years old. Two vaccines are being used in developed countries: Rotarix (GSK) and RotaTeq (Merk). Rotarix vaccine was produced from master seed G1P8 and RotaTeq vaccine was from the coordination of human rotavirus strains G1, G2, G3, G4 and cow rotavirus strain. Thanks to the help of WHO, Ministry of Health and Ministry of Science and Technology, Center for research and production of vaccines and biologicals \ufffd?Ha Noi made study of creating rotavirus master seed G4P6 for Rota vaccine production in Vietnam. Objectives: To evaluate the safety and potency of rotavirus master seed G4P6 in the laboratory and experimental animals. Subjects and method: Rotavirus master seed G4P6 (2001019203) lot 1 (MS-PL5) and lot 2 (MS-PL5) produced in 2005, preserved at -800C were determined potency by Immunofluorescence (IF) method and tested for safety on rabits and rats. Results:2 lots of Rotavirus master seed G4P6 that had been produced in Center for research and production of vaccines and biologicals \ufffd?Ha Noi had high titre and safety in the laboratory and experimental animals. Conclusion: The results were the basis of Rota vaccine production in Vietnam.
Rotavirus/ isolation & ; purification ; Rotavirus Vaccines/ isolation & ; purification ; contraindications

Background: Group A Rotavirus is the main cause of diarrhea in human especially in children under 5 years old. Rotavirus master seeds were established from group A Rotavirus (mainly 3 strains: G1P8, G1P4 and G4P6) causing acute diarrhea for children in Vietnam. The master seeds must meet the potency and safety in the laboratory as well as animal experiments under the guidance of WHO. Objectives: To determine the safety and immune response of rotavirus master seeds in monkeys to confirm their safety and effect in preclinical stage. Subjects and method: Baby Macacca mulatta monkeys had average weight of 1.5 kg (provided by monkey ranch in Reu island in Quang Ninh province) were tested and determined neutral antibody by immunofluorescence technique. Results: The rotavirus master seeds: G1P8 (KH0118); G1P4 (2001019210) and G4P6 (2001019203) had good safety and immune response with high neutral antibody after 3 dose vaccination in baby Macacca mulatta monkeys. Conclusion: The rotavirus master seeds would be a base for diarrhea vaccine production in Viet Nam under the guidance of the World Health Organization.
Rotavirus/ immunology ; Haplorhini