Enhanced Packaging and Reformulations Give New Life to Biologics

The market for biotherapeutics has grown significantly since the first biologic drug was launched over 50 years ago. More than 250 biologic molecules have been developed and launched since 1996, and today biologics account for nearly 30% of compounds in the drug-development pipeline.
Recently, research and development (R&D) resources have focused not only on new molecular entities but also on improvements to commercially available products. Reformulations now comprise nearly 50% of new drug application (NDA) approvals at the US Food and Drug Administration (FDA).2 At drug-delivery companies focusing on injectable therapeutics, over 50% of the molecules in the pipelines are biologics, with many projects focused on developing sustained-release formulations.3

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.

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