Wacker Chemie AG has officially opened a new production facility for pharmaceutical proteins in Jena. The new plant is part of the Munich-based chemical company’s investment program to enlarge its biotech operations. The expansion enables WACKER to accommodate its customers’ rapidly 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 some €18 million.
WACKER has substantially boosted capacity at its Jena site in order to cope with a growing need for high-efficiency biologics production processes, and to meet rising customer demand. The existing GMP-certified (Good Manufacturing Practice) facility now has twice as much production area. A completely new facility for product-purification enables up to three times higher product yields per batch. The new unit meets the GMP requirements of both the US Food and Drug Administration 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.
"Demand for advanced biotech products is growing worldwide. Innovative, biotechnological processes such as WACKER’s secretion system ESETEC® allow us to meet demand and continue to shape the developments in biotechnology here in Germany," WACKER Executive Board member Auguste Willems said during his speech to commission the new facility.
To accommodate growing customer inquiries, the facilities of Wacker Biotech GmbH have been greatly expanded over the last two years. The around €18 million investment by the WACKER Group at Jena’s Beutenberg Campus encompassed two projects: in addition to the expansion of the GMP facility, a new lab building for process development and quality control which was built and put into operation back in 2009.
"We now have an ideal system for developing the sophisticated processes and analytical techniques of modern, microbe-based biologics," explains Dr. Thomas Maier, managing director of Wacker Biotech GmbH. "This allows WACKER to optimize 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."
Traditional production methods aside, the focus of the new unit is on the WACKER 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 robust fermentation processes can be validated, and they permit high, reproducible yields.