10.04.16
A biologic candidate developed by a Japanese global pharmaceutical company and manufactured at Ajinomoto Althea using its CORYNEX Protein Expression System, has entered Phase I trials.
The CORYNEX system is a protein expression platform that combines attributes of mammalian and microbial systems to simplify processes to produce and purify recombinant proteins with reduced production costs and greater speed. The system utilizes a gram-positive bacterium, Corynebacterium glutamicum, to produce soluble, properly folded proteins from microbial fermentation. Biologically active recombinant proteins are secreted directly into the growth medium with high purity thereby facilitating more efficient scale-up and transfer to GMP manufacturing.
After successful feasibility studies performed at Ajinomoto, the sponsor company engaged with Ajinomoto and its subsidiary Althea to scale up and produce GMP material at the 1000L scale to support a Phase I study. Successful GMP batches have been produced and the first human subjects have been dosed.
The CORYNEX system is a protein expression platform that combines attributes of mammalian and microbial systems to simplify processes to produce and purify recombinant proteins with reduced production costs and greater speed. The system utilizes a gram-positive bacterium, Corynebacterium glutamicum, to produce soluble, properly folded proteins from microbial fermentation. Biologically active recombinant proteins are secreted directly into the growth medium with high purity thereby facilitating more efficient scale-up and transfer to GMP manufacturing.
After successful feasibility studies performed at Ajinomoto, the sponsor company engaged with Ajinomoto and its subsidiary Althea to scale up and produce GMP material at the 1000L scale to support a Phase I study. Successful GMP batches have been produced and the first human subjects have been dosed.