The presence of certain viruses needs to be controlled in pharmaceutical products derived from human and animal origin.
CONTROL OF VIRUSES IN PHARMACEUTICAL PRODUCTS
The presence of certain
viruses needs to be controlled in pharmaceutical products derived from human
and animal origin. This includes blood products such as human plasma for
fractionation intended for the manufacture of human antithrombin III, human
coagulation factor VII, VIII, IX, XI, dried prothrombin complex, dried
fibrinogen, normal immunoglobulin, human α1proteinase inhibitor, and human von Willebrand factor, for which
tests for the presence of antibodies against HIV1 and HIV2, hepatitis B surface
antigen (HBsAg), and antibodies against hepatitis C virus are required. For the
urine-derived urofollitropin (obtained from postmenopausal women), tests for
hepatitis virus antigens and HIV antigen are needed.
The risk of a
pharmaceutical product being contaminated by viruses depends mainly on the origin
of the product component (e.g. species, organ, tissue), the history of the
donor, the amount of material used, the manufacturing process and its capacity
to remove/ destroy any contaminants. In addition, the infectivity and
pathogenicity of possible viral contaminants must be taken into consideration,
notably when considering the route of administration of the medicinal product
(i.e. transdermal delivery would carry less risk than an injection). A risk
assessment is generally carried out for these products containing a component
from human or animal origin, which takes into consideration factors affecting
the potential level of infectious particles and those related to the use of the
product.
Thus stringent controls
are applied to the raw materials, in process samples and to the final product. In
addition, one or more validated procedures to remove or destroy viruses can be
applied. The type of inactivation measures used must be validated against a
range of representative viruses (i.e. enveloped, nonenveloped, DNA, and RNA
viruses) with different degrees of resistance to that type of treatment.
Furthermore, early inactivation limits the extent of contamination. For the
preparation of vaccines, the inactivation process must ensure that it does not
affect the antigenicity while killing the virus and other potential
contaminants such as mycoplasmas; for example for the preparation of influenza
vaccine, the inactivation process chosen must cause minimum alteration of the
haemagglutinin and neuraminidase antigens.
Related Topics
TH 2019 - 2023 pharmacy180.com; Developed by Therithal info.