BASF will transfer the pharmaceutical production of KolliphorTM TPGS (Speziol TPGS Pharma, vitamin E polyethylene glycol succinate), manufactured at the company’s Kankakee, Ill., site, to its Minden, Germany, facility. The transition is expected to be completed by the first quarter of 2014.
Kolliphor TPGS is a water-soluble derivative of vitamin E that can directly enhance the bioavailability of poorly soluble active substances. It is commonly used in pharmaceutical and nutritional formulations, but also in cosmetics.
“Expanding the Kolliphor TPGS manufacturing capacity at our Minden site is another example of BASF’s commitment to the pharmaceutical and dietary supplement market. The relocation creates a more centralized production facility, reduces complexity in the production setup, and provides room for future expansion,” said Dr. Thorsten Schmeller, head of global marketing new products at BASF’s Global Business Unit Pharma Ingredients & Services. The Minden site has manufactured active pharmaceutical ingredients (APIs) and excipients under cGMP for more than 70 years and is regularly inspected by the FDA and European health authorities. Schmeller: “Thanks to the ICH Q7 quality management standards at our Minden site, we will be able to offer a Kolliphor TPGS grade that fulfills the requirements of an API.”
Commitment to a seamless transition
Until the production in Minden is fully operational, BASF will continue to manufacture Kolliphor TPGS at the Kankakee site, which will fully support pharmaceutical and nutraceutical customers during the transition. “We have scheduled a generous supply overlap that we expect allows for a seamless transition,” added Schmeller. “Our projection also takes into account the appropriate qualification period required to transition products used in pharmaceutical applications . ” Kolliphor TPGS production at the Minden site is expected to start in the first quarter of 2013.
The Kankakee site remains an important production facility for BASF’s nutrition and health business. Besides food ingredients, the company manufactures ingredients for soaps, shampoos, detergents, coatings, inks and adhesives at the site.
Additionally it has plasticizing effects that are very beneficial for emerging platform technologies in the pharmaceutical industry such as hot melt extrusion (HME).