Formulation development for biologic drugs is the process of determining the best way to deliver stable active ingredients to the intended patient population. Drug formulation is one of the most critical aspects of the product life cycle from early clinical trials to commercial product launch. The selected inactive ingredients, or excipients, must ensure stability of the biologic drug under a variety of conditions, including shipment and storage. To achieve a successful formulation, critical decisions that depend upon a range of biochemical and physical attributes of the drug substance must be made early in the development process. As a result, extensive characterization of the biomolecule and the physicochemical properties of the drug product are necessary to understand the potential impact of various excipients on stability and critical quality attributes. Tanvex CDMO has developed unique biophysical and analytical screening platforms that are faster and more accurate and cost-effective than traditional approaches to biopharmaceutical formulation development.

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