Phyton Biotech has been granted a Certificate of suitability to European Pharmacopeia (CEP) by the European Directorate for the Quality of Medicines and HealthCare (EDQM) for its docetaxel anhydrous active pharmaceutical ingredient (API).
Phyton is the first North American or European based contract API supplier to be granted a CEP for docetaxel.
Importantly, Phyton’s docetaxel API is not subject to the current worldwide shortage of 10-deacetylbaccatin (10-DAB) starting material because it uses paclitaxel from its own plant cell fermentation facility as its starting material.
Comments CTO and VP, Business Development, Roland Franke, PhD: “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. 10-DAB is derived from yew tree plantations which - as we are seeing again - are subject to climate, environmental, and harvesting issues. Our docetaxel API is different. It uses paclitaxel as its starting material; and the paclitaxel we use is via plant cell fermentation that is produced at our own facility near Hamburg, Germany. Troubling as well, is that 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.”
Adds General Manger, Marc Iacobucci: “Phyton has invested heavily to become the leading supplier of high quality docetaxel and paclitaxel API in the world. 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 and their inherent problems related to the environment, sustainability, reliability, and consistent quality. We control the production and quality of our products from starting material to finished API, which few other such suppliers can claim. This CEP follows the CEP we were granted last summer for our plant cell fermentation paclitaxel API. These milestones are especially important to Phyton as the CEP is widely recognized as certification of API quality; and makes it much easier for our customers to gain market authorization to use our API’s both in highly regulated markets and those emerging markets that are placing more emphasis on product quality.”
The CEP procedure assesses and concludes suitability of monographs to control the chemical purity and quality for any substance covered by a European Pharmacopoeia monograph; and checks compliance at the manufacturing and/or distribution site(s) covered by CEPs with both Good Manufacturing Practices for medicinal products and the information submitted in the application.
The CEP, in part, facilitates and simplifies exchanges between regulators and industry to ensure the quality of substances used in the production of pharmaceutical products and that such substances comply with the European Pharmacopoeia; and facilitates the management of marketing authorization applications for medicinal products.