Microneedle technologies are advancing rapidly, unlocking new possibilities for delivering vaccines, biologics and cosmetic actives directly into the skin.
But accurately assessing their performance depends on one critical factor that often gets overlooked:
๐๐จ๐ฐ ๐๐ฅ๐จ๐ฌ๐๐ฅ๐ฒ ๐๐จ๐๐ฌ ๐ฒ๐จ๐ฎ๐ซ ๐ญ๐๐ฌ๐ญ ๐ฌ๐ฒ๐ฌ๐ญ๐๐ฆ ๐๐๐๐ฎ๐ซ๐๐ญ๐๐ฅ๐ฒ ๐ซ๐๐๐ฅ๐๐๐ญ ๐ซ๐๐๐ฅ ๐ก๐ฎ๐ฆ๐๐ง ๐ฌ๐ค๐ข๐ง, ๐๐จ๐ญ๐ก ๐๐ข๐จ๐ฅ๐จ๐ ๐ข๐๐๐ฅ๐ฅ๐ฒ ๐๐ง๐ ๐ฆ๐๐๐ก๐๐ง๐ข๐๐๐ฅ๐ฅ๐ฒ?
The choice of model is critical, yet many studies still rely on simplified test systems such as artificial membranes orย ๐ฆ๐น ๐ท๐ช๐ท๐ฐย ย porcine skin. While convenient, these platforms fail to replicate the true structural and mechanical properties of living human skin on the body, often leading to misleading conclusions around penetration and device performance.
Even when human skin is used, traditionalย ๐ฆ๐น ๐ท๐ช๐ท๐ฐย ย models fail to preserve key mechanical properties such asย ๐ฉ๐ก๐ฒ๐ฌ๐ข๐จ๐ฅ๐จ๐ ๐ข๐๐๐ฅ ๐ญ๐๐ง๐ฌ๐ข๐จ๐ง, a key factor that directly impacts:
โ Needle penetration mechanics
โ Delivery depth
โ Dissolution rates
โ Overall device behavior, including patch adhesion
โ Downstream biological responses
When that tension is lost,ย performance canย be significantly misrepresented.
๐๐๐ง๐๐ค๐ข๐งโข ๐ฐ๐๐ฌ ๐๐๐ฌ๐ข๐ ๐ง๐๐ ๐ญ๐จ ๐ฌ๐จ๐ฅ๐ฏ๐ ๐ญ๐ก๐ข๐ฌ ๐ฉ๐ซ๐จ๐๐ฅ๐๐ฆ.
By preserving physiological tension, TenSkinโขย enables a more realistic and reliable assessment of microneedle performance in human skin, addressing several of the concerns outlined in a recent white paper focused on understanding, informing and defining the regulatory science of microneedle-based dosage forms that are applied to the skin [Dul ๐ฆ๐ต ๐ข๐ญ., 2025: https://lnkd.in/eBZDYfY6]
At Ten Bio, our technology and expertise in microneedle evaluation enable us to design and perform studies which address several critical factors that influence not only microneedle-based device performance but biological tissue responses:
โย ๐๐ค๐ข๐ง ๐ฆ๐๐๐ก๐๐ง๐ข๐๐ฌย โ stiffness, viscoelasticity and pre-tension
โย ๐๐ค๐ข๐ง ๐ฌ๐ญ๐ซ๐ฎ๐๐ญ๐ฎ๐ซ๐ย โ full-thickness human skin with all layers intact, including optionally adipose tissue
โย ๐๐ข๐๐ซ๐จ๐ง๐๐๐๐ฅ๐ ๐๐๐ฌ๐ข๐ ๐งย โ geometry, spacing and backing material properties
โย ๐๐๐ฌ๐ญ ๐๐จ๐ง๐๐ข๐ญ๐ข๐จ๐ง๐ฌย โ application strategies/devices and environmental control
โย ๐๐ข๐จ๐ฅ๐จ๐ ๐ข๐๐๐ฅ ๐ซ๐๐ฌ๐ฉ๐จ๐ง๐ฌ๐๐ฌย โ tissue interactions with microneedles and delivered actives (APIs) including local response and downstream efficacy
As microneedle technologies evolve and mature, generating data that truly reflects how human skin behaves, mechanically and biologically, is essential to de-risk development, enable confident decision-making, and accelerate progress.
Reference: Dul M et al. (2025) White paper: Understanding, informing and defining the regulatory science of microneedle-based dosage forms that are applied to the skin. Journal of Controlled Release. https://doi.org/10.1016/j.jconrel.2024.11.056
ย
Ten Bio Team 2026
