Ajinomoto Althea, Inc. (“Althea”) announced that a biologics candidate developed by a Japanese global pharmaceutical company and manufactured at Ajinomoto Althea using CORYNEX® Protein Expression System, has entered phase I clinical trials.
The CORYNEX® system of Ajinomoto Co., Inc. (“Ajinomoto Co.”) is a proprietary protein expression platform that combines the best attributes of mammalian and microbial systems. It greatly simplifies the processes to produce and purify recombinant proteins resulting in reduced production costs and greatly speed time to market. The system utilizes a gram-positive bacterium, Corynebacterium glutamicum, which is non-endotoxic, non-sporulating, non-pathogenic, and genome-sequenced. Unlike other bacterial systems, the CORYNEX® system produces 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. Due to these attributes, the CORYNEX® system has proven successful with difficult-to-produce proteins that could not be effectively manufactured using other production systems.
After successful feasibility studies performed at Ajinomoto Co., the Japanese global pharmaceutical company engaged with Ajinomoto Co. and its subsidiary Althea to scale up and produce GMP material at the 1000L scale to support a phase 1 clinical study. Today Ajinomoto Co. has announced successful GMP batches have been produced and the first human subjects have been dosed.
Ajinomoto Co. currently provides expression services to worldwide clients and offers research and manufacturing licenses for pharmaceutical companies that choose use the technology in their in-house development programs. Althea’s drug substance manufacturing group has successfully transferred the CORYNEX® system in-house and now offers scale-up and GMP manufacturing services for clients with difficult-to-produce proteins. In addition, Althea offers a unique range of aseptic fill & finish to address production needs that span small scale early stage clinical products to larger scale commercial products, making it a perfect match for early stage clinical work using the CORYNEX® system.