Standardization

Botanical products derived from multiple or even single plants are complex mixtures of numerous chemical entities; i.e. multiple variables may require monitoring and control in order to secure standardization.  The standardization of a botanical API plays a major role in compliance with the FDA guidelines for Botanical Drugs developers and manufacturers. However, characterization of a botanical pharmaceutical material, even when derived from a single plant, remains a formidable task.

Se-cure applies an integrated methodology in order to provide the utmost control to guarantee product standardization and batch to batch therapeutic consistency.  Throughout the process, active and passive controls are used to reach stability of the botanical API’s biological state, as well as prevention of undesired traces of heavy metals, residual pesticides or infectious microorganisms.

In a cGMP production facility, Se-cure practices its multi-layer standardization control methodology:

  • Raw material standardization - a proprietary process (non-genetic) intended to stabilise the API level in the botanical raw material
  • Inline control - using analytical tools for monitoring consistency of formulations while in process, and bio-chemical tools to monitor presence of residuals and microorganisms. 
  • Finished product control - using analytical tools and bio-assays as the finished product release criteria.

The integrated, multi-layer methodology, set in accordance with the FDA’s Botanical Drug Guidelines, has proven to be both effective and efficient. Se-cure’s stringent botanical API and finished product's specifications and controls, ensure the highest quality of its products.

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