API maker Phyton Biotech LLC has been granted a CEP for the production of paclitaxel using plant cell-based fermentation.
Phyton’s receipt of the Certificate of suitability to European Pharmacopeia (CEP) this week made it one of only two producers certified by the European Directorate for the Quality of Medicines (EDQM) to make the API using fermentation.
The vast majority of other EDQM CEP holders for paclitaxel use either semi-synthetic production processes or natural sources to make the cancer drug, which can have significant environmental consequences according to the Canadian company’s general manager Marc Iacobucci
“Our tremendous capacity to produce paclitaxel from plant cell fermentation eliminates reliance on yew tree plantations and their inherent problems related to the environment, sustainability, reliability, and consistent quality.”
The only other paclitaxel producer to use fermentation and hold a CEP is Korean company Samyang Genex – a subsidiary for Samyang Corp – against which Phyton launched a legal case in October last year.
Phyton’s main grievence is Samyang’s use of plant cell fermentation technology and cell lines derived from Taxus species to produce the API, which the firm believes infringes on its own production platform.
The suit– which is before the courts in Germany where sister subsidiary Phyton Biotech GmBH is based – calls for Samyang “to cease and desist from offering, putting on the market, selling, owning, or otherwise using paclitaxel in the country.”
Vancouver, Canada-based Phyton Biotech LLC is a subsidiary of Phyton Limited, which in turn is owned by DFB Pharmaceuticals.