BIO 2026: Engineering Long-Acting Precision
As the drug development pipeline shifts toward complex biologics, traditional oral or frequent dosing regimens are being replaced by long-acting formulations, reveals David Westberg from Nanexa.
Long-acting injectables (LAIs) are increasingly recognized as a vital solution to patient non-compliance in chronic therapeutic areas. However, shifting a therapy from a daily or weekly oral regimen to a monthly or quarterly injectable format introduces substantial clinical and formulation hurdles. According to David Westberg, CEO of Nanexa, a successful transition hinges on three interconnected factors: drug potency; strict control over the release profile; and highly optimized injection volumes.
“One needs to look at the potency of the drug itself... so that the total volume injected is not too high,” Westberg explains. “But then, of course, one needs to have a very good control of the release profile so that the majority of what's injected will be released the first days or weeks. One needs to have a technology that allows you to inject what could be a once-quarterly dose and still have a very smooth profile.”
A central metric in achieving this smooth profile is the peak-to-trough ratio, which dictates therapeutic stability and minimizes side effects. Westberg points to Nanexa's recent success with the GLP-1 receptor agonist semaglutide as a major validation of their approach. While weekly commercial formulations of the drug typically maintain a peak-to-trough ratio between 1.8 and 1.9, Nanexa's formulation technology achieved a ratio below 1.5 for both once-monthly and once-quarterly dosing schedules.
Additionally, large proteins and peptides, such as semaglutide, present certain formulation vulnerabilities, meaning that traditional depot formulations often fail. These limitations are bypassed by Nanexa through the use of a specialized gas-phase precision coating process that treats the surface of spray-dried organic drug particles directly, Westberg reveals.
To prevent the API from breaking down during manufacturing, the entire process is conducted under highly controlled, dry conditions, Westberg explains. “Using our technology, we have a gas-phase dry process, we work in temperatures that are slightly elevated from room temperature, like 30 to 40 degrees, and in low pressure, and we have this gas-phase reaction that does not involve really the molecule as such, but just the surface of the particle,” he says.
This atomic-layer encapsulation creates a physical barrier that isolates the biologic while it resides within the tissue depot and protects it over extended timeframes, Westberg continues. “There is no enzymatic cleavage or anything like it when it is in the depot,” he specifies. “So, what is released on, let's say day 75 or day 90, is an intact molecule and that is, of course, key.”
Nanexa will be present at this year’s BIO conference on the Swedish Pavilion, located at stand #3417
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About the Speaker
David Westberg is the CEO of Nanexa. David has more than 25 years of experience in the pharmaceutical industry from, among others, Development Manager, and Global Project Manager at Pharmacia and Pharmacia UpJohn. He has also been Head of project management at Orexo for two drug projects, taken from idea to approved product, and launch in the United States. David has also worked as a consultant in the pharmaceutical industry with business development. He has a Master of Science in Polymer Chemistry from the Royal Institute of Technology, Sweden.
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