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发表于 2022-12-9 17:09:39
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FDA Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (2007)
1. for bulk plasmid, supercoiled plasmid content (preferably >80%);
2. for bulk plasmid, the presence of bacterial host cell macromolecules including DNA, RNA, and protein (preferably <1%);
3. The amount of endotoxin in plasmid DNA vaccine preparations should not exceed 40 EU/mg plasmid.
FDA Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (2020)
1. For viral vectors, limit the amount of residual DNA for continuous non-tumorigenic cells to less than 10 ng/dose and the DNA size to below approximately 200 base pairs.
FDA Guidance for Industry: Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up (2020)
1. Test a sufficient amount of vector to demonstrate that your vector contains <1 RCR per patient dose, when applicable to your clinical manufacturing practice. |
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