Regarding quality control and control of contaminations.
It is very important question.
biotechnology laboratory works in sterile conditions (GMP and GLP certifications).
At the moment, panel of tests to detect serious pathogens like endogenous viruses, exogenous viruses and prions. 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.
良好生产规范 (良好生产规范) and Good laboratory practice ( 良好实验室规范) certified facility (
and under certified manufacturing conditions.
