The extension has included an addition or enhancement of a series of advanced technologies at contract manufacturing organization (CMO) Evonik’s production sites. The technologies include: high-potency active pharmaceutical ingredient (HPAPI), fermentation, methoxy polyethylene glycol (mPEGs) and continuous processing.
Jean-Luc Herbeaux, senior vice president at Evonik, told us that the number of highly-specialized chemical compounds needed for production continues to grow.
He explained that more than a dozen steps are required to manufacture these compounds and they are needed in areas including oncology; further, he told us that each complicated step can require specialized technologies like biocatalysis, continuous processes, and special containment.
“Pharma companies are often unwilling to develop or maintain such specialized capabilities. That is why market demand amongst pharmaceutical companies is growing rapidly for CMO partners that have the right mix of advanced technologies, global scale and service for the reliable industrialization and commercialization of these compounds,” said Herbeaux.
He said that by leveraging Evonik’s competencies as a global specialty chemical company, it can address the emerging needs of pharmaceutical customers and companies in complementary markets.
The expansion will allow customers to select a single CMO partner that has enabling technologies and manufacturing processes to scale-up. This can help reduce complexity and risk for customers, according to Herbeaux.
“In the field of enantiopure compounds, Evonik is able to apply chemocatalysis, enzymatic chemistry, fermentation and chiral pool chemistry so the customer will always get the best solution,” said Herbeux.
Evonik has two facilities, one in the US and one in Europe, which have both increased its assets footprint and added additional capacities to support production of HPAPI. With the expansion, Evonik will now be able to run several HPAPI projects in parallel down to an exposure level of 5ng/m3.