The challenge for drug makers, however, is to bring about these improvements while addressing the added packaging, manufacturing, and formulation challenges inherent in biologics, due to their unique sizes, structures, and stability profiles. More than 95% of large molecules are administered either through intravenous (IV) infusion or through subcutaneous injection,4 routes of administration that are highly efficacious yet undesirable to many patients. As a result, new technologies continue to emerge to improve administration and storage of these molecules.ENHANCED PACKAGING AND FORMULATION STRATEGIES
In the short term, drug makers are moving toward enhanced packaging that allows for safer, more intuitive reconstitution of lyophilized powder formulations and less complicated administration of biologics.
Mid-range improvements typically involve improved drug-delivery devices, a substantial growth area for drug manufacturers. Industry analysts predict that over the next three to four years the sale of biologics packaged with a device will show higher growth than the same product packaged alone, driven by the market appeal of devices that make administration of biologics easier.4
The best approach for a particular biologic compound depends on the molecule's market environment, point of use, and the company's short- and long-term strategy for its product and business.
SOLUTIONS FOR SUBCUTANEOUS AND INTRAMUSCULAR INJECTABLES
Today approximately 75% of biologics are administered via subcutaneous or intramuscular injection.4 Most recent advancements in drug-delivery technologies related to injectable biologics have focused on devices and technologies that improve safety, patient compliance, and convenience in both administration and storage.
Short-term strategies primarily deliver improvements in convenience, compliance, or improved safety for healthcare workers as well as patients.