Full
Outline
Because of the particularity of the production cell substrates, the potential risk of virus contamination in recombinant biological products produced by eukaryotic expression system could be introduced in various ways. Major regulatory agencies in the world-wide have issued guidelines about the viral safety in the production of such products, among which Q5A (R1), issued by the International Council for Harmonization (ICH), is widely accepted and highly recognized by different countries. In order to explore the scientific nature of the technical requirements and arouse the common thinking of the industry and regulatory authorities, this article discussed the current research progress in virus removal and inactivation process in the production of recombinant biological products from five aspects, which are the applicable scope of the guideline, new virus assays and analytical methods, the progress of validation approaches, new validation method that have emerged or evolved, and virus clearance validation and risk mitigation strategies for advanced manufacturing.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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