The clinical application of gene therapy and DNA immunization will depend not only on efficacy but also on safety and the
ease with which the technology may be adapted for large-scale pharmaceutical production. The new purification process described
here combines novel and conventional purification technologies as high-throughput alternatives. TFF membranes and a perfusion
media were used for concentration and recovery of the pIDKE2 plasmid to reduce process time and to increase the productivity
of the downstream process. Although the yields are lower when using this process, the advantages of this method over existing
plasmid DNA purification methods include improved plasmid purity and the elimination of undesirable process additives such
as toxic organic extractants and animal-derived enzymes. Finally, this process may be used as a simple, scalable, and applicable
method for the production of the pIDKE2 plasmid, which is being used in Phase 2 human clinical trials.
Miladys Limonta is the principal researcher, Gabriel Marquez is the head, and Isabel Rey is a technician in the downstream process development department, Martha Pupo is a specialist and Odalys Ruiz is a researcher in the analytical development department, Yalena Amador-Canizares is a researcher and Santiago Duenas-Carrera is the head of the hepatitis C vaccine department, all at the Centre for Genetic Engineering and Biotechnology, Havana, Cuba,
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