For years, the FDA has faced a challenge: how to regulate HCT/P products like amnion patches. The promise is undeniable — natural scaffolds that protect, cover, and support healing. But adoption has been slowed by one recurring issue: proof.
How do we clearly demonstrate that processing does not alter the original relevant characteristics of tissue? That amnion still functions in its homologous use?
The FDA recently published a study using Nuclear Magnetic Resonance (NMR) to compare Humira with its biosimilars.
Why does this matter? Because NMR can reveal subtle, hidden changes in complex biologics that other tools often miss — from protein folding shifts to oxidation events.
For those of us working in the birth tissue industry, the lesson is clear:
🗸 Regulatory bodies are moving toward deeper structural analytics to prove integrity and comparability.
🗸 Techniques like NMR could become essential in demonstrating that minimally manipulated tissues preserve their original relevant characteristics — the very foundation of homologous use under FDA’s HCT/P framework.
🗸 Beyond safety, these methods may help validate packaging, storage, and processing protocols that safeguard the natural architecture of amnion.
At the American Amnion Association, we believe innovation and compliance must advance together.
As regulators embrace next-generation tools, our community has an opportunity to lead — by adopting advanced analytics not only as safeguards, but as pathways to credibility, access, and wider acceptance of birth tissue therapies.
At the American Amnion Association, we see this as more than technology. It’s a chance to build trust, accelerate access, promote innovation and ensure that the healing potential of amnion reaches more patients, faster.
Read the full abstract here.