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ACTIP
position paper
on
unconventional agents of spongiform
encephalopathy
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 Background
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The
nature of the transmissable agents that cause
spongiform encephalopathies, such as scrapie or
bovine spongiform encephalopathy (BSE) in animals,
or Kuru, Creutzfeldt-Jakob disease (CJD) and
Gerstman- Straussler-Scheinker disease (GSS) in
man, is still controversial. Several lines of
evidence indicate that the transmissable agents
consist of a modified form of the normal host
protein, PrPc, that is devoid of any nucleic acid.
However, due to the number of distinct strains of
the agent with distinct phenotypes, it has been
suggested that a nucleic acid must be a component
of the agent; however, no specific nucleic acid has
sofar been detected.
These agents persist in infected individuals
without being detectable and only after an
incubation period of several years do they cause
clinical signs as the progressive neurodegenerative
disease finally leads to a fatal outcome.
BSE has been confirmed in several countries such as
the UK, Switzerland, France, the Republic of
Ireland, Italy, Canada and Portugal. The incidence
of new cases, however, is decreasing. Scrapie, on
the other hand, has been diagnosed in all five
continents. Spongiform encephalopathy disease has
now been confirmed in many other animal
species.
Despite extensive epidemiological studies there is
no evidence for the transmission of scrapie to
humans. However, the possibility exists that the
species barriers to BSE may be different and
therefore due prudence is warranted when biological
materials from species susceptable to these
diseases are used in the production of medical
products.
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Concern and suggestions of Animal Cell Technology
Industrial Platform
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1.
Rapid, sensitive, diagnostic test
development
It is essential to develop diagnostic tests which
are rapid and sensitive, to enable the
pharmaceutical industry to assess the safety of
products derived from materials of animal origin,
or in the use of animal products such as serum, for
their manufacture. In addition, such tests are
essential for the agricultural industry to diagnose
disease in animals. The current bioassays in mice
and hamsters are sensitive but take one to two
years to detect low levels of the agent.
2.
Host range
The potential for different causative agents of
spongiform encephalopathies to cross the species
barrier must be actively researched. These studies
will give a better insight into both the biology
and the potential risk of these agents.
3.
Fundamental research - establish and identify the
nature of the agent
It is critical that future work is conducted to
establish the nature of these agents. This will
require a programme of fundamental research,
focused on the cellular protein, PrP, which appears
to play a key role in the development of these
diseases.
First
edition of this position paper: Rotterdam, January
1992
First update of this position paper: Rotterdam,
April 1996
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Summary
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Scheme
for handling of bovine material in the
pharmaceutical industry
Scheme
drafted by the German Health authority
The following six areas have to be observed when
material of bovine origin is used in the
pharmaceutical industry. In each of these six areas
points can be scored. The lower the risk, the more
points are awarded. If the product obtains 20 or
more points, it is considered safe.
Six
areas to be observed:
- country
of origin of the bovine material, plus mode of
rearing and of feeding the donor
animals;
- age
of the donor animals;
- source
of the material (from which organ is it
derived);
- kind
of process for the production of the final
pharmaceutical product (are inactivation or
removal steps involved?);
- amount
of original bovine material used per daily
dose;
- length
of time of application;
- mode
of application.
Note:
The approval for all drugs, containing bovine
material of risk that have not scored 20 points or
more in the above scheme, have been suspended in
Germany. Initially this will last until the end of
September 1997.
ACTIP, Rotterdam, April 1996
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