Increasing Precision In Inhalation Delivery

Why It Matters

Improved inhalation formulations could unlock a multi‑billion‑dollar market for biologics, offering patients needle‑free therapy and forcing pharma to rethink drug‑delivery strategies.

Key Takeaways

• Growing interest in inhaled delivery of complex biologics.
• Formulation science critical for stability and potency of macro‑molecules.
• Need for dry‑powder forms to eliminate cold‑chain reliance.
• Collaboration between academia and industry essential for particle engineering.
• Regulatory pathways for inhaled biologics remain undefined and complex.

Summary

The discussion centers on how advancing formulation science can sharpen the precision of inhaled therapeutics, especially as companies target both lung and nasal routes.

Speakers note that roughly half of the pipeline now consists of biologics, prompting a push to deliver larger macro‑molecules such as insulin via aerosols. Stability, potency, and bioavailability constraints intensify the need for robust excipients and dry‑powder technologies that avoid cold‑chain dependence.

A recurring theme is the gap between academic research on particle surface chemistry, size, and mucopenetration and industry’s ability to translate those findings into marketable products. Regulators—including SBA, CEDA, and CDR—are cited as key stakeholders in defining pathways for inhaled biologics and bio‑equivalence assessments.

If these formulation hurdles are solved, inhalation could become a viable route for high‑value biologics, opening new revenue streams and reducing reliance on injections, while also reshaping regulatory frameworks for bio‑similar inhaled products.

Original Description

In this segment of the Drug Delivery Leader Live online event, Just Breathe: Increasing Efficacy And Expanding Targets With Inhalation Delivery, Chief Editor Tom von Gunden asks panelist Geraldine Venthoye about innovations in inhalation formulation and delivery for enabling expanded and precision therapeutic targeting. Venthoye points to key aspects of particle science and payload release, as well as the need for advanced analytical tools.