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...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Finlay Ediciones
2014-12-01
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| Series: | VacciMonitor |
| Subjects: | |
| Online Access: | http://scielo.sld.cu/scielo.php?script=sci_pdf&pid=S1025-028X2014000300002&lng=es&nrm=iso&tlng=es |
| Summary: | 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. |
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| ISSN: | 1025-028X 1025-0298 |