SAN DIEGO, Jan. 9, 2014 /PRNewswire/ — Ajinomoto Althea, Inc., a leading Contract Manufacturing Organization providing development and manufacturing services for biotechnology and pharmaceutical companies, announced today its new product offering, Corynex, to produce secreted, soluble, properly folded proteins from microbial fermentation. In addition, the company announced the successful finalization of the production process for a therapeutic protein primed to enter a Phase I clinical trial. The client was previously using Schizosaccharomyces pombe as an expression system, which garnered disappointing results due to a very low productivity. With a need for a more efficient productivity to support clinical trials, Ajinomoto Althea demonstrated expression with its patented Corynex platform. Unlike other microbial systems, Corynex is based on the bacterium Corynebacterium glutamicum, which secretes proteins into the cell culture supernatant in active form with minimal host contaminants.

Ajinomoto Althea was able to effectively scale up production of this therapeutic protein from test tubes to small scale fermentation. A yield of approximately 1 gram per liter was achieved – an exceptional yield due to the difficult nature of the protein. Additionally, column chromatography purification achieved a purity of greater than 98%, which is an excellent purity for a Phase I product.

“We are extremely pleased to have successfully and fully demonstrated the Corynex platform process here in San Diego. With the addition of Corynex, we are now offering an even more complete suite of solutions to our customers from process development through clinical manufacturing for a very wide variety of recombinant proteins,” said Kristin DeFife, Director of Biologics Manufacturing at Ajinomoto Althea.

ABOUT AJINOMOTO ALTHEA, INC. Ajinomoto Althea, Inc. is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Ajinomoto Althea offers comprehensive development services including: upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing. Ajinomoto Althea’s formulation technology platform includes Crystalomics®, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. Ajinomoto Althea also has an innovative and proven recombinant protein expression technology called Corynex.