Drug Manufacturing

For selective extraction and on-line chromatographic purification of natural molecules

A Problematic Situation

Current manufacturing methods for natural pharmaceuticals use large volumes of toxic organic solvents to extract the active ingredients that occur in trace amounts (5 to 500 parts per million). Process yields are low, and procedures are time-consuming and resource-intensive. The toxic organic solvents used are not readily recyclable, require expensive disposal and often leave toxic residuals.

The Need For Change

Taxus-brevifolia-treesFor example, paclitaxel (Taxol®) was initially isolated from the bark of the slow growing Pacific yew, Taxus brevifolia, by several toxic organic solvents in as many as 19 processing steps. The bark of 100- to 200-year-old Pacific yews was used, even though it killed the tree, because it was a relatively clean matrix that made the isolation possible.

The manufacturing of paclitaxel from yew bark was thus based on a species that was becoming rapidly endangered and a technology that generated a significant amount of environmental waste.

However, the isolation and purification of paclitaxel from yew needles, the renewable portion of the tree, by conventional organic solvent procedures was made extremely difficult by the presence of non-polar waxes, lipids, chlorophylls and other bioactive compounds in the yew needle.

The CXP Solution

The SuperFluids™ (supercritical, critical or near-critical fluids with or without polar cosolvents) extraction and purification (CXP) process circumvents these manufacturing difficulties and resource limitations.

By utilizing SuperFluids™, CXP selectively extracts and purifies paclitaxel and related taxoids from yew needles (leaves), a renewable biomass resource, of the cloned ornamental yew, Taxus media "hicksii", in just five steps.

The CXP Process

CXP utilizes SuperFluids™ CO2 with or without an alcohol for the selective extraction of natural drugs combined with online SuperFluids™ chromatographic purification.

The process reduces the number of extraction and chromatographic purification steps, and decreases processing times from several days to less than 24 hours.

This technology is rapid, selective and cost-effective. Products of CXP technology are free of toxic organic solvents, environmentally friendly and truly "green."

CXP for Plant Medicines and Marine Therapeutics

CXP technology can be used for the manufacturing of:

  • Anticancer drugs paclitaxel and other taxoids from Taxus species
  • Betulinic acid from the white oak tree Betula alba
  • Bryostatin-1 that occurs in parts per million range in the sea-moss, Bugula neritina
  • Camptothecin, a unique topoisomerase inhibitor from the Chinese plant Camptotheca acuminata
  • Cyclopamine, a potent Molecular Hedgehog pathway antagonist and anticancer compound isolated from the roots of the California shrub Veratrum californicum
  • Cannabinoids such as Δ9-THC from Cannabis sativa
  • Quality-of-life medicines (dietary supplements or nutraceuticals) following current Good Manufacturing Practices (cGMP) guidelines.

Contract Manufacturing

Utilizing SuperFluids™ CXP for the selective extraction and on-line chromatographic purification, we will isolate and manufacture complex natural molecules for strategic corporate partners and on a contract basis.

Drug-Manufacturing Taxus-Yew-Under-Cultivation
Drug-Manufacturing Taxus-Yew-Farm
Drug-Manufacturing CXP-Plant

 

Patent

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White Paper

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