Fit for Purpose
At Cobra we have worked on the development of both naked plasmid DNA and viral gene therapy products for over 20 years. After some rather extended development times, it has been very rewarding to see a number progress out of Phase II clinical studies and customers wanting to take these products into Phase III studies.
This, though, brings some interesting dilemmas from a manufacturing perspective. When you are involved in production of material for early clinical evaluation, time scales a...
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