In reaction to the constantly growing worldwide demand of cytotoxic and other highly potent active pharmaceutical ingredients (HPAPIs)
In reaction to the constantly growing worldwide demand of cytotoxic and other highly potent active pharmaceutical ingredients (HPAPIs), ChemCon is expanding its manufacturing capabilities for HPAPIs in multi-kilogram quantities by containment down to 0.1 μg/m3 OEL. The new multi-purpose isolator train is currently being installed at the company site in Freiburg, Germany. ChemCon expects it to become fully operative in spring 2012.
Reflecting recent trends in the pharmaceutical industry, it is estimated that more than 40% of all new APIs fall within the HPAPI category. ChemCon has been producing such materials under cGMP conditions almost since its inception in 1997 and is capitalizing on the vast product experience. The award-winning strategy of utilizing dedicated equipment already proved to be decisive in order to safely exclude even the slightest cross-contamination.
To compensate any risk increase possibly connected with higher biological activity, all aspects of the manufacturing process are covered: Safety, health and environmental experts assess compound potency, evaluate production and monitor practices. They ensure that compound toxicology is accounted for by all applicable procedures. Moreover, rigid waste management is in place.
A pharmacologically active ingredient or intermediate is considered a HPAPI if its biological activity level is at approximately 150 μg/kg of body weight. The resulting low occupational exposure limit for the product requires special containment during processing. Besides cytotoxic reagents, hormonal drugs and high potency analgesics are other relevant categories.
About ChemCon:
ChemCon GmbH is a leading global supplier of high-quality active pharmaceutical ingredients (API), located in Freiburg, Germany. The company is specialized on small molecule chemistry – organic and inorganic. Based around chemical development on various stages of drug development ChemCon offers an all-in-one-hand service including full analytical support, complete documentation and outstanding quality management. Learn more about the company at www.chemcon.com.
Contact:
Dr. Thomas Huebsch Tel.: +49 (0)761-5597-310
Head of Marketing Fax: +49 (0)761-5597-449
ChemCon GmbH E-Mail: Info@chemcon.com
Engesserstr. 4b
79108 Freiburg i.Br.
Germany
