Medical Devices

Process Expertise

Our protein scientists and engineers have successfully developed dozens of recombinant proteins and monoclonal antibodies (mAbs) through preclinical, clinical and commercial stages, including post-approval changes and biosimilars development. We have worked with proteins from a variety of expression systems and with various posttranslational or chemical modifications (PEGylation, Fc fusions, hyperglycosylation, radiolabeling, enzymatic processing, etc). We have expertise in both upstream and downstream processing technologies, from strain development through aseptic fill/finish.