By Fran DeGrazio, senior industry and technical advisor, Drug Delivery Leader
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Biologics-based drugs and therapies are redefining what modern medicine can achieve. From programmable mRNA therapeutics, through ADCs (antibody-drug conjugates), to tri-specific antibody formulations, these advances offer the promise of life-changing therapies more effectively than ever before.
In providing benefits to patients, many of these innovative therapies use formulation enhancers to improve stability, provide targeted release with enhanced bioavailability, and enable alternative routes of administration. Those routes can, for some biologics-based therapies, include oral delivery. However, the vast majority will, ultimately, need to be delivered into the body by way of a device, often as a combination product.
More so than for traditional chemically constructed small molecule drugs, designing effective delivery systems for biologics can bring significant challenges. These include challenges that go beyond typical compatibility or stability issues, each with direct implications for the package or device. Some challenges, such as increasing delivery volumes to patients, are well discussed while others receive less attention.
For those reasons, thorough understanding of a therapy's characteristics and technical requirements is essential for evaluating, selecting, and/or engineering the proper device to be used in a combination product. Meeting these criteria, along with addressing safety and user needs, constitutes the primary goals of product development.
As I often do (and recently did in an article similarly focused on drug delivery advances), below I offer my thoughts and recommendations on six key packaging and delivery challenges to address, resolve, or overcome in the development of biologics-based therapies.
Challenge #1: Chemical Compatibility May Not Ensure Deliverability
In the biopharmaceutical industry, compatibility is typically associated with the chemical or biological stability of the drug within its container. Many recently introduced biologics do demonstrate increased sensitivity to their packaging environment.
However, to illustrate distinctive challenges in delivering biologics, it’s helpful to consider compatibility from a different angle: that is, its influence on the functional performance of the delivery device. Two real-world examples I have experienced are particularly relevant to this issue, though I acknowledge that other cases also exist.
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Biologics-based drugs and therapies are redefining what modern medicine can achieve. From programmable mRNA therapeutics, through ADCs (antibody-drug conjugates), to tri-specific antibody formulations, these advances offer the promise of life-changing therapies more effectively than ever before.
