In this module, we dive into the Ph. Eur. world of microbiology, starting with the conventional tests such as the test for sterility, the chapters for microbial examination of non-sterile products and the mycoplasma chapter. We then cover the field of rapid microbiological methods and how their use is promoted in the Ph. Eur.
The second part of the module is devoted to pyrogenicity testing and the phasing out of the rabbit pyrogen test. We update you on where the Ph. Eur. is heading and focus on animal-free tests - the monocyte activation test (MAT), and recombinant factor C (rFC).
Target audience
This training programme is of interest to staff members of national regulatory bodies and scientists involved in the development, manufacturing, quality control, quality assurance and licensing of medicinal products. It is ideal also for new and junior staff members wanting to familiarise themselves with the Ph. Eur. in the field of biologicals.
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Duration: 2 hours, 12 minutes.
Programme:
- Microbiology chapters by Emmanuelle Charton and Thuy Bourgeois (00:00 – 47:28)
- Rapid microbiological methods and Mycoplasmas by Solène Le Maux and Thuy Bourgeois (47:28 – 1:25:26)
- Pyrogenicity (BET, rFC, MAT, strategy) by Gwenaël Cirefice (1:25:26 – 2:11:43)
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