As a result of its specially optimised processes and many years of experience, the company only requires seven months for the development of a cell line, including bioprocess development and the development of a purification process, in addition to providing of all necessary analytical data.

For this reason, UGA Biopharma GmbH pays particularly close attention to the productivity, stability and quality of the clones when developing new cell lines. If the cell line is contaminated or the isolated monoclonal cell lines (clones) are unstable, the drug may end up being unusable – with correspondingly high financial losses for the manufacturer. Many factors can significantly influence the quality of biologics manufactured in this way, including process conditions during manufacturing, such as temperature during fermentation, pH, dissolved oxygen concentration and nutrient supply and, of course, the cell line used. By contrast, biologics are manufactured using genetically modified, living cells in bioreactors.

Traditionally, drugs used in chemotherapy or antibiotics were produced using chemical synthesis. In this way, monoclonal and highly productive cell lines can be developed within just four months, and an optimised bioprocess within a further three.ĭownload the full article for Development of biologics as a PDF here Using an optimised expression vector means that highly productive clones can be generated. For this reason, contract developer UGA Biopharma GmbH has developed a high-speed cell line development workflow including analytics, purification and bioprocess development in bioreactors. The desired biomolecules (biologics) are manufactured using living systems, consequently a careful development and selection process of the cell line to be used, as well as thorough checks, are absolutely essential in order to ensure straightforward production later. However, the route from the lab to mass production is much more complicated for biologics than for conventional drugs. The extent of their market potential is revealed by the fact that the number of patent applications has been on the rise for decades now. Biologics offer new therapy options for numerous diseases: They are already used to treat cancer and autoimmune diseases such as rheumatoid arthritis as useful alternatives to standard therapies.

Biologics development lifecycle