OneAI™ for Biosimilar Comparability
An Additional Analytical Layer for Demonstrating Similarity
OneAI™ provides repeatable, multidimensional biospectral characterization designed to support comparison between biosimilar and reference biologic products.
Compare More Than a Single Measurement
Biosimilar development depends on demonstrating that a proposed product is highly similar to its reference product.
OneAI™ can compare biospectral signatures across products, samples and lots—providing objective measurements of similarity, consistency and change.
It is designed to complement established analytical methods, not replace them, by adding a repeatable characterization layer to the analytical comparability framework.
Building Toward Regulatory Application
Purity Biologics is working with experienced biosimilar development and regulatory experts to evaluate how OneAI™-generated data can be incorporated into structured comparability and regulatory-development frameworks.
Current work is focused on applying the technology to real biosimilar analytical data and defining where OneAI can provide additional evidentiary value.