The use of bio-assays is a common practice for identifying and quantifying drugs. The use of bio-assays for the identification of botanical APIs, however, is extremely challenging.  At the source of the challenge is the frequent inability to identify the entire botanical complex.
To bridge a gap identified with the CMC challenges, related to biological drugs (posing similar control challenges), the FDA acknowledged the use of a substance's fingerprint representation as means of API control, in cases where the API itself is not fully defined.  

Innovatively addressing the challenge, Se-cure has invested heavily in developing a ground breaking solution, tracing the bio-chemical fingerprint of its botanical API through the development of proprietary bio-assays. The tool developed in-house simulate the intended physiological mechanism of action of the botanical API,  which is used as an instrument for tracing and quantifying the botanical API levels in each drug batch. Implementing such bio-assays as a manufacturing control, optimally assures both bio-chemical consistency as well as therapeutic batch to batch consistency.

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