Process development is the link between research and the subsequent commercial production of biopharmaceuticals. It always aims to develop a cost-effective and robust manufacturing process that can be validated and that yields maximum quantities of high quality product, while all process and product specifications are complied with.
Process control development, process parameter optimization, process scale-up and process validation are multifunctional skills that require an integrated approach to be carried out successfully.
Wacker Biotech has the experience and expertise to develop processes that take customers’ demands for rapid availability of clinical materials into account, while bearing in mind the long-term demands on commercial production processes.
We carefully document all process development work involved. Early integration into project management and establishing project teams streamlines the bioprocess development steps, allowing for an efficient and transparent development process.
Bioprocess development always starts with selecting the right expression and cell bank system, followed by fermentation and downstream process development, along with intensive and comprehensive process and product analysis.