Evonik Industries has broadened its capabilities in finished drug product formulation and clinical supply manufacturing and can now handle drug products containing highly potent active pharmaceutical ingredients (HPAPIs) in Darmstadt, Germany, and Birmingham, Alabama/USA. Investments in high containment facilities and upgrades in the laboratory and GMP areas in Birmingham enable Evonik to handle HPAPIs with occupational exposure limits (OEL) as low as 0.1µg/m3 and in Darmstadt as low as 1 µg/m3. Starting 2014, OEL as low as 0.1µg/m3 will also be possible in Darmstadt.
The broad portfolio of Evonik competencies in terms of formulation development and clinical supply of oral and parenteral drugs can now also be applied to HPAPIs. "Active ingredients, functional excipients and tailored formulation development contribute to the ultimate success of advanced drugs and treatments. We are now in a position to offer our customers comprehensive services for the increasingly important class of HPAPIs," says Dr. Thomas Riermeier, Head of the Pharma Polymers & Services product line at Health Care Business Line of Evonik.
HPAPIs are substances that are pharmacologically active at very low concentrations. These active ingredients typically include certain hormones, peptides and cytostatic agents as well as new chemical entities (NCEs) that have not been completely characterized. The high potency of these drugs makes special precautions necessary to protect employees and the environment. Here, Evonik has implemented safety measures that meet the highest standards.
"The number of companies in the world that work with highly potent active pharmaceutical ingredients is limited," says Riermeier. "Our small and large scale HPAPI production capacities in Hanau and Lafayette (Tippecanoe Laboratories), together with our new capabilities for formulation development and clinical sample production in Darmstadt and Birmingham, make Evonik an ideal partner to the pharmaceutical industry in HPAPI manufacturing and formulation."
Evonik, the creative industrial group from Germany, is one of the world leaders
in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik’s corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms.
Evonik is active in over 100 countries around the world. In fiscal 2012 more than 33,000 employees generated sales of around €13.4 billion and an operating profit (adjusted EBITDA) of about €2.4 billion (excluding Real Estate in both cases).
In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.