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« INSTRUMENTATION
Japanese Pharmacopoeia).8
within the PDG.
Animal Welfare
The question of animal welfare is often raised in the context of rFC.
The Ph. Eur. approach to this issue is laid out in its Introduction:
" Use of animals. In accordance with the European Convention on the
protection of animals used for experimental and other scientific purposes
(1986), the Commission is committed to the reduction of animal usage
wherever possible in pharmacopeial testing, and encourages those
associated with its work to seek alternative procedures. An animal test is
included in a monograph only if it has clearly been demonstrated that it
is necessary to achieve satisfactory control for pharmacopeial purposes. "
Strictly speaking, rFC does not fall within the scope of the abovementioned
Council of Europe Convention, as the horseshoe crab is
not directly used in pharmacopoeia testing. Nonetheless and very
importantly, rFC avoids the use of a reagent extracted from a natural
source and endangered species. As a single molecular entity, it also
has higher standardization potential and as such represents significant
technological progress. Last but not least, there is the crucial question
of supply of the reagent: with horseshoe crabs absent from its
coastlines, for Europe, the use of a recombinant alternative avoids
potential supply shortages and a dependency on non-European
countries; the potential supply concerns prompted by complete
reliance on a single natural resource (the horseshoe crab) must also
be taken into account. The recombinant source is an obvious step
towards independence in this regard.
The pyrogenicity project fits perfectly within the scope of the
" Replacement " aspect of the 3Rs, i.e. " technologies or approaches
which directly replace or avoid the use of animals in experiments
where they would otherwise have been used. " Although the
replacement of animals is a significant achievement in itself, there
will be additional benefits from changing from in vivo to in vitro tests,
including increased scope for standardization and reduced variability
which, together, constitute a significant technological advancement.
The situation will be reviewed in five years, after the respective texts
have undergone their revision process.
Conclusion
Over the last 50 years the Ph. Eur. has addressed the question of
pyrogenicity using the analytical techniques available at the time,
moving from animal tests towards in vitro methods and therefore
promoting the use of standardized methods for a better control of
medicines in Europe. The Ph. Eur. has recently engaged on a path that
will put an end to the use of rabbits in pyrogen testing and increase the
use of synthetic reagents for the detection of bacterial endotoxins.4
The topic is currently under discussion
Acknowledgements
The author wishes to thank the experts of the Ph. Eur., in particular the
members of the Bacterial Endotoxin Test (BET) Working Party under
the dedicated and enthusiastic leadership of Dr. Ingo Spreitzer, for
their invaluable work.
References
2.
3.
European Directorate for the Quality of Medicines & HealthCare (EDQM). Alternatives to
Animal Testing. Available at: https://www.edqm.eu/en/alternatives-animal-testing.
European Partnership for Alternative Approaches to Animal Testing (EPAA). EPAA Annual
Conference 2018: Pooling resources to promote the use of alternative methods for advancing
safety assessment. Available at: https://wayback.archive-it.org/12090/20211007084311/
https://ec.europa.eu/growth/content/14th-epaa-annual-conference-pooling-resourcespromote-use-alternative-methods-advancing_en.
Accessed September 17, 2018.
4.
5.
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010
on the protection of animals used for scientific purposes. Available at: https://eur-lex.
europa.eu/eli/dir/2010/63/2019-06-26. Accessed June 26, 2019.
European Directorate for the Quality of Medicines & HealthCare (EDQM). News room.
European Pharmacopoeia to put an end to the rabbit pyrogen test. Available at: https://
www.edqm.eu/en/news/european-pharmacopoeia-put-end-rabbit-pyrogen-test.
Accessed June 28, 2021.
6.
7.
European Directorate for the Quality of Medicines & HealthCare (EDQM). Pharmeuropa
online. Available at: https://pharmeuropa.edqm.eu/home.
European Directorate for the Quality of Medicines & HealthCare (EDQM). News room.
Recombinant factor C: new Ph. Eur. chapter available as of 1 July 2020. Available at:
https://www.edqm.eu/en/news/recombinant-factor-c-new-ph-eur-chapter-available1-july-2020.
Accessed July 1, 2020.
8.
European Directorate for the Quality of Medicines & HealthCare (EDQM). News room.
Webinar " Using recombinant factor C for bacterial endotoxin testing in the Ph. Eur.: how
far have we come, how far have we to go? " Available at: https://www.edqm.eu/en/news/
webinar-using-recombinant-factor-c-bacterial-endotoxin-testing-ph-eur-how-far-havewe-come-how.
Accessed February 22, 2021.
9.
European Directorate for the Quality of Medicines & HealthCare (EDQM). International
Harmonisation. Available at: https://www.edqm.eu/en/international-harmonisation.
Author Biographies
Emmanuelle Charton holds a PhD in biochemistry from
the Institut National Agronomique de Paris-Grignon.
Since 2006 she is Head of Division B in the European
Pharmacopoeia department at the European Directorate
for the Quality of Medicines and HealthCare (EDQM). The Scientific
Secretariat for the elaboration of European Pharmacopoeia texts
related to microbiology fall under the responsibility of her division.
Her work experience includes QA/QC in a facility for the production of
parenteral products and preparation to GMP inspections in a global
pharmaceutical company, research and development in biochemistry
in a global company selling food and chemicals. She has over 25 years
experience at the EDQM, including as scientific administrator to the
groups of experts in the fields of biology and microbiology and as a
supervisor to the corresponding work in the EDQM laboratory.
www.americanpharmaceuticalreview.com |
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https://www.edqm.eu/en/alternatives-animal-testing https://wayback.archive-it.org/12090/20211007084311/https://ec.europa.eu/growth/content/14th-epaa-annual-conference-pooling-resources-promote-use-alternative-methods-advancing_en https://eur-lex.europa.eu/eli/dir/2010/63/2019-06-26 https:// www.edqm.eu/en/news/european-pharmacopoeia-put-end-rabbit-pyrogen-test https://pharmeuropa.edqm.eu/home https://www.edqm.eu/en/news/recombinant-factor-c-new-ph-eur-chapter-available-1-july-2020 https://www.edqm.eu/en/news/webinar-using-recombinant-factor-c-bacterial-endotoxin-testing-ph-eur-how-far-havewe-come-how https://www.edqm.eu/en/international-harmonisation http://www.americanpharmaceuticalreview.com

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