[Bio-safety testing for retroviral vector as gene therapy delivery system].

OBJECTIVE

To generate a bio-safety testing system including the testing of sterility, mycoplasma and replication-competent retroviruses(RCR) in the study of gene therapy anti-hepatitis B virus by intracellular immunization.

METHODS

Mycoplasma was detected by polymerase chain reaction. S+/L- assay, NIH3T3 amplification and rescue assay of neo gene were performed to determine RCR.

RESULTS

The results showed that all of the packaging cell lines were negative for aerobic, anaerobic bacteria and fungi. One of the packaging cell lines was positive for mycoplasma. No RCR was detected in all of the packaging cell lines.

CONCLUSIONS

The results suggested that the methods using in present report are stable and sensitive, it is very useful for bio-safety testing of gene therapy in clinical trials.