Full
Outline
The risk control of viral contamination has always been an important part of the safety control of recombinant biotechnology products. At present, China has not issued technical guidelines for viral safety control in the clinical trial application stage for recombinant therapeutic biotech products, while the sources of technical guidelines in the marketing stage are complicated, which to some extent brings troubles to researchers and delays the development process of new drugs. Therefore, in order to improve the R&D quality of related products and accelerate the application process, this article will discuss the basic technical requirements for viral safety control of recombinant therapeutic biotechnology products in the clinical trial application phase from three aspects: the technical requirements of the current technical guidelines, the technical requirements of the Chinese Pharmacopoeia, and the review practice.
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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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