Exhibition and Presentation at RAFT® 14

This system has some advantages compared with other protein expression systems. First, C. glutamicum hardly secrete host cell proteins of itself into the culture supernatant. Therefore, the target protein can be secreted with high purity. Second advantage is about correct folding of the secreted protein. A protein which has complex structure such as including disulfide bonds, homo-dimer, and hetero-dimer can be secreted as active form. Third advantage is endotoxin-free. C. glutamicum is a gram-positive bacterium, which does not produce endotoxin natively. So, it is not needed to care about endotoxin clearance during manufacturing process.
　

To expand the versatility of this system, we developed the CspB-fusion method to increase the secretion titer, and identified the Tat-pathway, which is a novel protein secretion pathway that differs from general protein-secretion pathway well known as Sec-pathway. Furthermore, we have developed efficient breeding technologies, such as signal peptide library and host strain library, to improve the productivity.
　

Now we are applying this system to produce biopharmaceuticals. So far, several proteins produced by this system have already been tested in clinical trials in US and EU. Recently, there are focused on antibody mimetic proteins as well as conventional major antibody therapeutics in the biopharma field, so we have tried the strain development to produce these proteins. As a result, various kinds of proteins could be successfully secreted, so it was demonstrated that CORYNEX® is very suitable system to produce antibody mimetics and fragment antibodies.
　

In this presentation, we introduce the detail and case study of CORYNEX® technology, and the perspective of the Ajinomoto’s biopharma services including contract development and manufacturing organization (CDMO) business.