CONCLUSIONS
Our process produces plasmid DNA (pDNA) with 95% purity, and the process fulfills all regulatory requirements and renders
pharmaceutical-grade pDNA The content of genomic DNA is lower than 5 ng per dose, RNA is not detectable by agarose gel electrophoresis;
endotoxin content is 0.77 EU per kg body weight, and the protein content is 4.1 μg per dose, which is lower than the limit
established.
In conclusion, this process, which combines size exclusion and membrane chromatography, met the criteria of purity, robustness,
and reproducibility required for manufacturing pharmaceutical-grade pDNA for human clinical trials.
Miladys Limonta is a principal researcher and Gabriel Márquez is the department head, both in downstream process development, Martha Pupo is a specialist in analytical development, and Odalys Ruíz is a researcher in fermentation development, all at the Centre for Genetic Engineering and Biotechnology, Havana, Cuba,
miladys.limonta@cigb.edu.cu
+(53-7) 271-6013.
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