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Continuous manufacturing is one of the development directions of the production process of recombinant biotechnology products in the future. The promulgation of important technical documents such as ICH Q13 also provides guidance for its application practice. However, in the field of viral safety control, there are great differences in control concepts and measures between continuous manufacturing and previous batch manufacturing mode. Starting with the process characteristics of continuous manufacturing, this paper makes a preliminary discussion on three aspects, which are the control of raw materials, in-process test, and virus removal/inactivation process validation. At the same time, as the cases of continuous manufacturing of recombinant biotechnology products are still limited, more comprehensive and meticulous control strategies and measures still need further accumulated and improved based on R&D and production experience. It is suggested that the applicants of this kind of products should fully communicate with the regulatory authorities before the application, so as to ensure the safety of the subjects or patients through scientific and rigorous trial design.
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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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