CAPA E LOMBADA - Arca - Fiocruz

ABSTRACT
The Age of Genetic Engineering and Modern Biotechnology, which began
in the 1970s, has had several applications in various business activities, among
of which are health and food. In health area the emphasis has been on the
biopharmaceutical industry that has had a rapid growth in recent years, because
these new drugs are aimed towards the therapy of diseases that afflict a
significant part of the world’s population. As an example, it can be mentioned the
recombinant human interferon-alpha 2b, which is part of the Drugs of Exceptional
Dispensation Program of the Ministry of Health, also is it in the Clinical Protocol
for Hepatitis C. In order to meet the demand of the Brazilian population for this
drug, in 2004, Bio-Manguinhos signed an Agreement on Technology Transfer
with the Center for Genetic and Biotechnology Engineering of Cuba (CIGB), so
that this medicine could be produced at national level. This study aimed at doing
a qualitative research to list the Fundamental Requirements for Transfer,
Registration, Establishment and Stability Parameters of Banks of E. coli Cells
expressing recombinant human interferon-alpha 2b. A questionnaire was
compiled for data collection. It was sent by e-mail to a number of regulatory
agencies and researchers of the scientific academy. This questionnaire aimed at
listing the main tests / requirements that banks must submit Cells. The overall
rate of return of questionnaires was 39.3%, and the rate of responses from
researchers was 62.5% and from regulatory agencies was 8.3%. The rate of
items marked was around 80%, then it was agreed that those items that had a
rate higher than 50% would be the essential requirements to be described. The
work was not validated due to the low rate of return of questionnaires from the
Regulatory Agencies. However, it is believed that what was described can serve
as the first step in developing a specific standard relating to control the Banks of
Prokaryotes Cells, since it represents the expertise opinion of researchers in the
scientific community. Yet, it contributes to the specific requirements that shall
eventually be established by ANVISA for the registration of a biogeneric /
biosimilar product.
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