Wacker opens new factory for biologics

As part of its ongoing investment in biotech, German chemical company Wacker Chemie has opened a new process-development building for the production of pharmaceutical proteins, or biologics, in Jena (Germany).

The new unit can now ship double-digit gram quantities of pure proteins for pre-clinical development, prior to scale-up in the GMP plant.

The extension is Wacker's response to fast-growing demand for Esetec, its E.coli secretion technology, which can be used to simplify and streamline production of a new class of biotherapeutics called antibody fragments in high yield.

Covering some 1,700m², the building is dedicated to process development and protein analysis along the entire process chain, from gene to highly pure protein. The equipment used for fermentation (capacities up to 30 litres), primary processing (centrifugation, filtration, homogenisation), downstream processing and protein modification (eg PEGylation) is designed to allow the processes to be upscaled to Wacker's GMP production.

In addition to the actual process laboratories, the new unit boasts modern analytical labs. As a result, Wacker Biotech will meet standards for analytical characterisation of products and processes. The full range of analytical tools is available: from biochemical assays to chromatography, electrophoresis, photometry, protein sequencing, and spectroscopy, through to trace analysis of impurities (DNA, HCP, endotoxins). Customers thus take delivery of a full process and analysis package from a single source.

A second extension at the Jena site will double the production area in the existing GMP plant and include a downstream processing facility. It will satisfy the US Food and Drug Administration's GMP requirements, as well as those of the European Medicines Agency. This extension is likely to come on-stream early next year.