Product quality of pharmaceuticals manufactured in biotechnology processes is to a large extent synonymous with the reduction and control of unwanted biological side-products. Production of biopharmaceutical proteins and secondary metabolites such as antibiotics are the result of biosynthetic capacity of the microbes or cells used. But this capacity may also contribute to turn the product molecules into molecular forms unacceptable in the final product, form side-metabolites that could harm the cell physiology and release contaminating cellular components. The main task for the ensuing process steps, the downstream procedures, is to reduce these impurities to acceptable levels that comply with the regulatory quality criteria.
Sorry, this page is available to members only.
If you have not registered with us yet, why not
register today for FREE and receive exclusive online access. Interested in receiving European Pharmaceutical Review in print? Subscribe today and guarantee the next six issues delivered direct to your desk, plus gain exclusive access online.
