Scaling Botanicals Drugs

Standardized and economically efficient scaling of botanicals is a major challenge in developing drugs from a botanical source. The interactions within botanical substances may yield unstable complexes that are not well-defined, hence, the great significance attributed to the drug’s CMC. The transition from small scale, “handcrafted” production into an industrialized and economics-driven process amplifies the complexity of controlling the botanical’s therapeutic consistency.

A well-thought and effective scaling strategy is a vital part of any new drug development program. Botanical drug scaling requires a carefully designed CMC, which will preserve the production's economic efficiency. Standard analytical tools are used to monitor batch to batch consistency, whereas tracing a well-defined, chemical entity is possible. However, in the handling of partial or undefined botanical complexes, conventional identification and quantifying methods fall short.  Thus, standardized scaling of therapeutics based on botanical raw materials, much like with biological therapeutics, is extremely challenging.  

In order to control batch to batch therapeutic consistency, Se-cure implemented an integrated CMC approach. An array of botanical API stabilization methods assure the product’s therapeutic consistency, starting at the botanical raw material level along the drug production and packaging process. Complementary, revolutionary and proprietary physiological mechanism of action simulation bio-assays are used for controlling the API  consistency. Using such bio-assays allows control of the API‘s quantity and affinity within production batches, both in-process and at the finished product level.

Recently acknowledged by the USFDA to be part of the DT56a (Femarelle®) complex CMC, this strategy will be further implemented in scaling other botanical drug candidates as a mean for assuring their batch to batch therapeutic consistency.

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