Establishment of an in vivo potency assay for the recombinant hepatit is B surface antigen in monovalent and combined vaccines
In this paper the development of potency assay in animals (mice) was made, with the objective of demonstrating the immunogenic power of the recombinant Hepatitis B surface antigen in monovalent and combined vaccines, produced at the Center of Genetic Engineering and Biotechnology. The potency test...
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| Format: | Article |
| Language: | English |
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Finlay Ediciones
2014-12-01
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| Series: | VacciMonitor |
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| Online Access: | http://scielo.sld.cu/scielo.php?script=sci_pdf&pid=S1025-028X2014000300002&lng=es&nrm=iso&tlng=es |
| _version_ | 1811274744841895936 |
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| author | Mabel Izquierdo-López Karelia Cosme-Diaz Gerardo García-Illera Zoe Núñez-Lamotte Yamila Martínez- Cuéllar Maribel Vega-Simón Lourdes Costa-Anguiano Marisel Quintana-Esquivel Ileana Rosales-Torres Omar Mosqueda-Lobaina |
| author_facet | Mabel Izquierdo-López Karelia Cosme-Diaz Gerardo García-Illera Zoe Núñez-Lamotte Yamila Martínez- Cuéllar Maribel Vega-Simón Lourdes Costa-Anguiano Marisel Quintana-Esquivel Ileana Rosales-Torres Omar Mosqueda-Lobaina |
| author_sort | Mabel Izquierdo-López |
| collection | DOAJ |
| description | In this paper the development of potency assay in animals (mice) was made, with the objective of
demonstrating the immunogenic power of the recombinant Hepatitis B surface antigen in monovalent and
combined vaccines, produced at the Center of Genetic Engineering and Biotechnology. The potency test
is a parameter in quality control and it is also a tool to demonstrate the consistency of the production
process. Parameters such as duration of the test, number of animals in the test, as well as different areas
for the maintenance of the animals were evaluated. The results on the applicability of the potency test, to
two presentations of the vaccines; monovalent Heberbiovac HB and pentavalent liquid in one vial
Heberpenta-L are shown, for which specificity studies, evaluating different vaccine lots, the behavior of
linearity, and parallelism, as well as establishing quality specification of the test were performed. This assay
led to the obtainment of reliable results for the vaccines evaluated, the consistent evaluation of the
immunogenic power and the monitoring of different production processes. |
| first_indexed | 2024-04-12T23:25:38Z |
| format | Article |
| id | doaj.art-0a3b62f1032e4bc98a90d6ab69948146 |
| institution | Directory Open Access Journal |
| issn | 1025-028X 1025-0298 |
| language | English |
| last_indexed | 2024-04-12T23:25:38Z |
| publishDate | 2014-12-01 |
| publisher | Finlay Ediciones |
| record_format | Article |
| series | VacciMonitor |
| spelling | doaj.art-0a3b62f1032e4bc98a90d6ab699481462022-12-22T03:12:25ZengFinlay EdicionesVacciMonitor1025-028X1025-02982014-12-012338390Establishment of an in vivo potency assay for the recombinant hepatit is B surface antigen in monovalent and combined vaccinesMabel Izquierdo-López0Karelia Cosme-Diaz1Gerardo García-Illera2Zoe Núñez-Lamotte3Yamila Martínez- Cuéllar4Maribel Vega-Simón5Lourdes Costa-Anguiano6Marisel Quintana-Esquivel7Ileana Rosales-Torres8Omar Mosqueda-Lobaina9Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.Centro de Ingeniería Genética y Biotecnología. Ave 31 e/ 158 y 190. Apartado Postal 10600. La Habana, Cuba.In this paper the development of potency assay in animals (mice) was made, with the objective of demonstrating the immunogenic power of the recombinant Hepatitis B surface antigen in monovalent and combined vaccines, produced at the Center of Genetic Engineering and Biotechnology. The potency test is a parameter in quality control and it is also a tool to demonstrate the consistency of the production process. Parameters such as duration of the test, number of animals in the test, as well as different areas for the maintenance of the animals were evaluated. The results on the applicability of the potency test, to two presentations of the vaccines; monovalent Heberbiovac HB and pentavalent liquid in one vial Heberpenta-L are shown, for which specificity studies, evaluating different vaccine lots, the behavior of linearity, and parallelism, as well as establishing quality specification of the test were performed. This assay led to the obtainment of reliable results for the vaccines evaluated, the consistent evaluation of the immunogenic power and the monitoring of different production processes.http://scielo.sld.cu/scielo.php?script=sci_pdf&pid=S1025-028X2014000300002&lng=es&nrm=iso&tlng=eshepatitis Bpotency testcombined vaccinesrecombinant hepatitis B vaccine |
| spellingShingle | Mabel Izquierdo-López Karelia Cosme-Diaz Gerardo García-Illera Zoe Núñez-Lamotte Yamila Martínez- Cuéllar Maribel Vega-Simón Lourdes Costa-Anguiano Marisel Quintana-Esquivel Ileana Rosales-Torres Omar Mosqueda-Lobaina Establishment of an in vivo potency assay for the recombinant hepatit is B surface antigen in monovalent and combined vaccines VacciMonitor hepatitis B potency test combined vaccines recombinant hepatitis B vaccine |
| title | Establishment of an in vivo potency assay for the recombinant hepatit is B surface antigen in monovalent and combined vaccines |
| title_full | Establishment of an in vivo potency assay for the recombinant hepatit is B surface antigen in monovalent and combined vaccines |
| title_fullStr | Establishment of an in vivo potency assay for the recombinant hepatit is B surface antigen in monovalent and combined vaccines |
| title_full_unstemmed | Establishment of an in vivo potency assay for the recombinant hepatit is B surface antigen in monovalent and combined vaccines |
| title_short | Establishment of an in vivo potency assay for the recombinant hepatit is B surface antigen in monovalent and combined vaccines |
| title_sort | establishment of an in vivo potency assay for the recombinant hepatit is b surface antigen in monovalent and combined vaccines |
| topic | hepatitis B potency test combined vaccines recombinant hepatitis B vaccine |
| url | http://scielo.sld.cu/scielo.php?script=sci_pdf&pid=S1025-028X2014000300002&lng=es&nrm=iso&tlng=es |
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