Wacker Chemie Opens New Production Facility For Pharma Proteins

Wacker Chemie said that the expansion will enable it to accommodate its customers’ growing demand for biotechnologically manufactured pharmaceuticals. Biologics are used to treat, among other things, cancer, multiple sclerosis and hepatitis.

The expansion, together with the new building for process development and quality control already completed last year, brings Wacker’s total investment in the Jena facility to around EUR18m.

The company said that the existing GMP-certified (Good Manufacturing Practice) facility now has twice as much production area. The new unit meets the GMP requirements of both the FDA and the European Medicines Agency EMEA.

Wacker Biotech can now provide those customers who have biopharmaceuticals at an advanced development stage with sufficient commercial capacity to supply the market.

Traditional production methods aside, the focus of the new unit will be on the proprietary technologies, ESETEC and Densetec, which enable simpler, more cost-efficient and high-yield production of biologics for the pharmaceuticals industry.

ESETEC is based on a patented E coli K12 strain, which is employed during fermentation to secrete recombinant proteins into the culture broth in natural conformation. Such extra-cellular production facilitates the cleanup of recombinant products and eliminates the complicated refolding stage. The net effect is to render production much more efficient and more cost-effective.

The ability to combine ESETEC secretion technology with Densetec, a special high-cell-density process for fermenting E coli, gives Wacker Biotech the capacity to produce active biologics both efficiently and in optimized space-time yields. These fermentation processes can be validated, and they permit high, reproducible yields, said the company.

Thomas Maier, managing director of Wacker Biotech, said: “We now have an ideal system for developing the sophisticated processes and analytical techniques of modern, microbe-based biologics.

“This allows Wacker to optimise the entire process chain, from lab operations to industrial GMP production. Customers thus benefit from a full process and analysis package provided from a single source. And with the expansion of our production capacities, we can now make our innovative ESETEC secretion technology available to still more customers.”