Pacesetter - Evonik recently made news when it opened its laboratory for highly potent APIs (HPAPIs) in Hanau, Germany while expanding its cGMP capacities for these ingredients to kilogram-scale production at its Tippecanoe site in Indiana. The new lab enables the company to develop and optimize syntheses for HPAPIs in Germany.

Also, the capacity expansion gives Evonik access to a total reactor volume for HPAPIs of 170 m3. This breaks down to about 135 m3 for production of HPAPIs in ton-scale and about 35 m3 for production of small quantities. "This allows us to cover the entire spectrum of HPAPI production, from clinical phases through commercialization," said Dr. Klaus Stingl, manager of Exclusive Synthesis within Evonik's new Health Care business line.

CHEManager Europe spoke to him about the growing trend of HPAPIs.

CHEManager Europe: Why did Evonik establish an HPAPI lab in Hanau and decide to expand the capacity in Lafayette?

Dr. Klaus Stingl: The acquisition of the Tippecanoe Laboratories site in Lafayette, Indiana, USA, in 2010 gave Evonik a leading position in the cGMP manufacturing of HP-APIs. As demand for this capability is increasing, Evonik recognized the need for further investment in this area in order to serve customers at all stages of the HPAPI life cycle, from development to commercial production.

Our investment in HPAPI pilot plant capacity at our Tippecanoe site complements our commercial scale manufacturing and allows us to provide customers with initial small volume quantities for clinical trial application. Our new HPAPI Process Research and Development center in Hanau, Germany, is a resource dedicated to the development and optimization of HPAPI chemical processes.

What are the main reasons for the growing demand for HPAPIs?

Dr. Klaus Stingl: The pharmaceutical industry is continuing to develop more specialized and targeted compounds with strong therapeutic effects, e.g. in the oncology space. These compounds are becoming increasingly potent, or have other effects at very low concentrations, which necessitate a specialized manufacturing capability. The successful handling of HPAPI compounds requires a proven expertise across all key production functions to protect employees, the environment, and product quality.

What growth for HPAPIs do you expect for the coming years? Do you see differences between NAFTA, EU and Asia?

Dr. Klaus Stingl: As the understanding of the underlying causes of diseases improves, specially designed pharmaceuticals will be increasingly able to treat diseases at lower doses. This will result in a growing global market for HPAPIs. In NAFTA and EU we forecast HPAPI growth for innovative originator products, while in Asia we predict significant growth for generic HPAPIs.