Commercializing DNA vaccines presents several challenges at each phase of development. Early phases require formulations with short term stability and minimal manufacturing requirements. Later phases focus on establishing robust formulations through stability studies, optimizing and validating manufacturing processes, and selecting a final commercial container. Key formulation challenges include achieving room temperature stability while minimizing DNA degradation and particles. Buffers like TE buffer with ethanol addition can enhance plasmid stability, as demonstrated through accelerated stability studies. Final container selection requires consideration of DNA's affinity for glass and potential for metal ion leaching. Cold chain management is also a challenge, making lyophilization or liquid ambient temperature distribution desirable objectives.

1. Commercializing DNA Vaccines DNA Vaccines 2011 Rick Hancock, President [email_address]

11. Plasmid Stability vs. Formulation Buffer

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