Wacker Chemie AG has expanded its biologics production facility, adding GMP manufacturing capacity and a process development building in response to customer demand.
Faced with pricing pressures from emerging markets and rising demand for biologics, some chemical companies, including Wacker and Lonza, have expanded production for higher margin products.
Wacker’s expansion includes an €18m ($24.5m) investment in its biologics production facility in Jena, Germany. The final phase of the expansion, which doubled the capacity of the existing good manufacturing practice (GMP) production facility, officially opened this week.
Also included in the second phase of expansion is a new facility for product purification. Wacker claims the new site can achieve up to three times higher product yield per batch and meets US Food and Drug Administration (FDA) and European Medicines Agency (EMA) GMP standards.
The first phase of expansion, which began operating in 2009, added a laboratory building for process development and quality control. This has given Wacker “an ideal system” for process development and analytics, according to Thomas Maier, managing director of Wacker Biotech.
Maier explained that completion of the second phase allows Wacker to “optimise the entire process chain, from lab operations to industrial GMP production”, adding that customers “benefit from a full process and analysis package provided from a single source”.
The facility will use Wacker’s proprietary technologies, Esetec and Densetec, which can make biologics production simpler, more cost-effective and boost yields, according to the company.
Esetec uses the patented Escherichia coli (E. coli) K12 strain during fermentation to secrete recombinant proteins into the culture broth.
Taking this approach eliminates the refolding stage and facilitates cleanup of recombinant products, making production more cost-effective, according to Wacker.
This will be used in conjunction with Densetec, a high-cell-density process for fermenting E. coli. Wacker claims the combination of these technologies makes production more efficient.