Evonik, a global CMO leader for API and advanced intermediates, today announced the completion of a €36 million expansion of its contract manufacturing capabilities in the U.S. and Europe. A series of advanced technologies, including high-potency API (HPAPI), fermentation, mPEGs and continuous processing, have been introduced or enhanced at multiple Evonik production sites over the last year.
“Our mission is to help our customers bring to market innovative molecules with complex manufacturing processes, and in this context, global scale, expertise and flexibility matter,” said Dr Jean-Luc Herbeaux, SVP and Head of the Evonik Health Care business line. “Evonik will continue to be a leader in advanced technologies that make the industrialization and commercialization of these highly specialized products possible.”
At its facility in Hanau, Germany, Evonik has recently commissioned a new modular cGMP continuous processing plant, a pilot plant for the custom synthesis of highly pure PEGs and mPEGs for pharmaceutical applications, as well as a cGMP suite for the small-scale production of HPAPI and ultra-HPAPI.
At its facilities in Tippecanoe, Indiana, U.S. and Hanau, Germany, Evonik has increased its asset footprint and added additional capacities to support the small, medium or large scale production of HPAPI. In addition to being the world’s largest HPAPI manufacturer, Evonik is now able to run several HPAPI projects in parallel down to an exposure level (OEL) of 5ng/m³.
At its facility in Slovakia, Evonik has recently invested in a new, flexible pilot plant for downstream processing. It is the sixth plant in a worldwide network to support microbial fermentation projects from strain development through to commercial manufacturing.
Dr Andreas Meudt, VP and Head of Exclusive Synthesis at Evonik said: “Advanced technologies will continue to be deployed across our global network in response to emerging customer needs. In parallel, our commitment to quality and regulatory excellence will continue to drive all business activities. The fact that our Tippecanoe facility in the U.S. has now recorded six consecutive FDA inspections without a Form 483 is an indication of how we can provide customers with peace-of-mind.”
The Exclusive Synthesis team from Evonik will be at CPhI Worldwide in Madrid between October 9 and 11 at booth 9K20. To request a meeting please contact: firstname.lastname@example.org.
Evonik will also host a webinar on continuous processes with Chemical and Engineering News (C&EN) on October 23 and 30. Register at http://cenm.ag/evonikwebinar.