Successful products require well defined, robust, scalable and reproducible processes that are commercially viable and regulatory compliant.
Our process development team has extensive expertise in all aspects of upstream and downstream development for a wide range of product types including complex recombinant proteins and monoclonal antibodies. The scientists who develop our processes are also responsible for effective technical transfer and successful scale-up.
Eden Biodesign’s facility has three segregated development suites. These mirror the cGMP suites for the dedicated application of mammalian and microbial technologies and use the same, scaled down technology platforms. Within these state of the art suites we undertake comprehensive process development using a range of upstream and downstream techniques and technologies.
Advanced characterisation is applied throughout biosimilar process development to ensure that the key product quality attributes are highly similar to those of the comparator reference product.