Evonik expands laboratory and production capacity for Highly Potent Active Pharmaceutical Ingredients
Investment in attractive pharmaceuticals market
Evonik Industries AG has set up a new laboratory at their Hanau site for highly potent active pharmaceutical ingredients (HPAPI) and expanded their cGMP capacity for HPAPI on a kilogram scale at Tippecanoe Laboratories (Lafayette, Indiana, USA). The new laboratory allows Evonik to develop and optimize syntheses for HPAPI now also in Germany. At their US site Evonik has similar laboratory installations. Given the expanded capacity, Evonik now has a reactor volume for HPAPI of a total of 170 m3. Of this volume, approximately 135 m3 are being used for the production of HPAPI on the metric-ton-scale, and approximately 35 m3 are being used for small batch production and manufacturing development quantities. “For exclusive synthesis, we can now manufacture the entire spectrum of highly potent active ingredients from the clinical phase to commercialization," noted Dr. Klaus Stingl, head of the Exclusive Synthesis product line of the company’s newly created Health Care business line.
Highly potent active ingredients are active pharmaceutical ingredients that are effective even at very low concentrations. A maximum of 0.2 milligrams per kilogram body weight or 10 milligrams per day is needed to have a significant therapeutic effect. These active ingredients include hormones, peptides, or cytostatic drugs for cancer treatment. “The demand for synthesis development and small batch production of HPAPIs for the clinical phase has gone up significantly in the past few years,” explains Stingl, justifying the investment in Hanau and Tippecanoe. According to Stingl, this is due in part to new developments in the treatment of tumors and endocrine diseases.
Due to their high potency, measures must be taken to protect the environment and laboratory and production employees when HPAPIs are handled. All of Evonik's HPAPI facilities are designed so that they can handle even active ingredients for which the allowed workplace threshold limit value (TWA, eight hours) is only 0.1 microgram per m3 of air.
“Currently there are very few companies worldwide that are even allowed to work with highly potent active ingredients,” says Kevin Haehl, who is responsible for the exclusive synthesis of active ingredients at Evonik’s Tippecanoe site. “Evonik is one of the most high-performance suppliers because, as one of the very few companies, we can also adhere to respectively low workplace threshold limit values. This means that we can also safely handle those active ingredients that, due to their extremely high potency in e.g. destroying cancerous tumors could be harmful to healthy people. “
The exclusive synthesis of highly potent active ingredients is carried out mainly at the Tippecanoe site, which Evonik acquired from the American pharmaceuticals company Eli Lilly in early 2010. The approximately 650 employees at the site have more than 20 years experience in handling, developing syntheses, and producing HPAPIs. With Evonik’s establishment of a similar laboratory in Hanau, this highly specialized expertise is now also available in Europe.
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