BioxelPharma inc.

Bioxel has created a very tight and robust manufacturing and supply chain that assures customers of high quality, reliability and timely delivery of paclitaxel in compliance with applicable pharmaceutical regulatory requirements. This process extends from harvesting the Canada yew through to paclitaxel purification in compliance with current Good Manufacturing Practices (cGMP) for pharmaceuticals. Bioxel has a competitive edge in Canada yew biomass sourcing, processing technology and regulatory compliance.

Biomass Extraction and Chemical Synthesis Regulatory Compliance

The Canada yew is recognized as the world's largest natural reservoir for taxanes, and Bioxel has harvesting rights on public and private lands covering an area of over 250,000 square kilometers with a high density of Canada yew. Our harvesting rights represent a key asset of the Corporation, as they ensure our customers a steady and reliable supply of taxane products. The Corporation harvests and processes Canada yew biomass in Quebec in compliance with sustainable harvesting principles. The harvested, crushed and dried biomass is inspected and released by Bioxel prior to being further processed to extract the valuable taxanes.

Taxanes contained in the biomass are extracted, concentrated and separated using initial chromatographic purification process. This stage isolates two intermediate products: 9-DHB and crude paclitaxel. The crude paclitaxel is the starting material for the cGMP manufacturing of pure (>98%) paclitaxel. The cGMP process uses a state-of-the-art high-throughput continuous SMB chromatographic process, wich give a high yield and high purity product. Bioxel also has the capability to convert 9-DHB into paclitaxel or docetaxel API using a patented high-yeilding chemical synthesis process.

Pharma & Bio Ingredients
(PDF : 1,6 MO)

SMB Paclitaxel Purification
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Taxanes are pharmaceutical ingredients that must be produced in full compliance with cGMP as outlined by the Food and Drug Administration, Health Canada and the European Agency for the Evaluation of Medicinal Products. Such products are also registered in these markets through Drug Master Files (DMFs) submitted and reviewed by the corresponding health agencies. Bioxel obtained DMFs for its paclitaxel in Canada, the United States and the European Union in 2004. The Corporation intends to apply for DMFs for taxanes manufactured through semi-synthesis in the near term. In June 2007, Bioxel registered its first docétaxel DMF with the US FDA.

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