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.”