In vivo delivery of DNA-based biopharmaceutical agents encoding proteins of interest (“DNA drugs”) offers a means for the production of protein by target regions of tissue in a subject. This product class derives activity from an ability to induce sustained endogenous protein expression from recipients’ own cells. These unique characteristics are favorable for multiple applications, several of which are now in clinical testing. Therapeutic Proteins: DNA drugs encoding autologous therapeutic proteins could serve as an alternative to long-term therapy based…
Formulation
Tackling Formulation and Delivery
The final hurdle in getting a product to market is the formulation and fill–finish step in process development. By their nature, protein therapeutics are more fragile and require a great deal of work to achieve product stability in final formulations. A cell line can be highly productive and efficient in protein production, but if you can’t stabilize the resulting protein and deliver it to patients intact, that’s a costly and useless exercise. The Formulation and Drug Delivery track of the…