The Canadian firm received a Certificate of suitability to the European Pharmacopoeia (CEP) for docetaxel anhydrous earlier this month, almost exactly a year after its paclitaxel active pharmaceutical ingredient (API) was granted similar status.
Like the paclitaxel API, Phyton produces its docetaxel using a plant cell-based fermentation that – according to CTO Roland Franke – gives the firm an advantage over manufacturers that rely on the starting material 10-deacetylbaccatin (10-DAB).
“Virtually every other docetaxel API supplier in the world uses 10-DAB as their docetaxel starting material. Unfortunately, docetaxel API is now in short supply because we are in one of the periodic shortages of 10-DAB.”
He explained that supplies of 10-DAB – which is extracted from yew trees – fluctuate as a result of environmental and climatic changes that impact plantations as well as difficulties associated with harvesting the substance itself.
Phyton’s approach – in contrast – uses the paclitaxel the firm produces at its fermentation plant in Hamburg, Germany as the starting material, meaning that supplies of its API are consistent.
Another advantage Phyton claims is that because it makes its own starting material in-house it is not likely to be impacted by any future shortages of paclitaxel, the majority of which is also made using 10-DAB as Franke explained.
“10-DAB is also the starting material for most sources of paclitaxel API so it would not surprise me to see near term and periodic shortages of this API too.”
This was echoed by company general manager, Marc Iacobucci: “Our enormous capacity to produce paclitaxel from plant cell fermentation, which incidentally is nearly 800 kg API annually at the fermentation stage, eliminates reliance on yew tree plantations.
“We control the production and quality of our products from starting material to finished API, which few other such suppliers can claim.”
One firm that could make such a claim is South Korea’s Samyang Genex, which also holds a CEP for paclitaxel produced via fermentation.
Phyton launched a lawsuit against Samyang in the German courts in October 2011 arguing that the South Korean firm’s use of fermentation technology and cell lines infringes on its own approach.
The Canadian API firm did not respond to in-Pharmatechnologist.com’s request for additional information.