Process development is the link between research and the subsequent commercial production of biopharmaceuticals. Its goal is to develop a cost-effective and robust manufacturing process that can be validated and yields maximum quantities of high quality product, while complying with all process and product specifications.
With over 20 years of experience and more than 200 successfully accomplished projects for our customers across the globe, Wacker Biotech has the expertise to develop processes that satisfy customers’ demands for rapid availability of clinical materials, while bearing in mind the long-term demands on commercial production processes. We serve customers from EMA, FDA and other regions including Korea & Japan. The BioProcess Development department with more than 50 full-time employees (the vast majority with academic degrees) is focused solely on process development, material supply for preclinical trials, strain/analytical development, process transfer and process characterization.