关于污染的质量控制和控制.
这是非常重要的问题.
生物技术实验室在无菌条件下 (GMP和GLP认证).
眼下, 检测严重病原体（例如内源性病毒）的测试面板, 外源性病毒. This panel of tests include reverse transcriptase detection as a general test for retroviruses, electron microscopy that can detect different kinds of viral particles and characterize many unknown isolates present in cell cultures and molecular techniques like PCR (conventional or real-time) and RT-PCR tests to include all the viruses that we know pose a risk to the product.
For prion detection, procedure based on the Western blot technology for the detection of antibodies (例如. 6H4, 1E4) that can be present in the cell cultures.
Any testing performed carefully evaluated before accepting the reagents for use.
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antibodies production tests (例如. MAP, RAP, HAP) – most convenient procedures in addition to the evaluation by means of electron microscopy.
良好的制造实践 (GMP) and Good laboratory practice ( GLP) certified facility (
and under certified manufacturing conditions.