TOKYO, Octorber 4, 2016 – Ajinomoto Co., Inc. (“Ajinomoto Co.”) announced today that a biopharmaceutical candidate manufactured using its proprietary Corynex®2 protein expression system has entered Phase I clinical trials for the first time, and the trials are currently ongoing. The drug candidate was manufactured under contract for a Japanese global pharmaceutical company by Ajinomoto Althea, Inc. (“Ajinomoto Althea”), a wholly owned subsidiary of Ajinomoto Co. that conducts development and manufacturing services for biopharmaceuticals in the United States. This milestone is expected to accelerate the adoption of Corynex® for biopharmaceutical manufacturing.
Launched in 2009, Corynex® is a contract manufacturing service using a proprietary protein expression platform that applies amino acid fermentation technologies developed by Ajinomoto Co. for over half a century. With its many advantages,3 Corynex® enables expression of various types of proteins that could not be manufactured with other production systems, and can achieve efficient, low-cost protein production. Ajinomoto Co. provides the Corynex® service to clients worldwide, and is also currently out-licensing the system to several pharmaceutical manufacturers. In 2013, Ajinomoto Co. acquired all of the capital stock of Althea Technologies, Inc. (currently Ajinomoto Althea), a CDMO4 in the United States providing contract development and cGMP5 manufacturing services for biopharmaceuticals, and is strengthening its advanced biomedical business.6
The manufacture of this biopharmaceutical candidate using Corynex® was based on a contract manufacturing agreement Ajinomoto Althea concluded with the Japanese global pharmaceutical company in 2013, and Ajinomoto Althea has subsequently provided numerous services including cGMP manufacturing. This is the first time since the launch of the Corynex® business in 2009 that a biopharmaceutical candidate manufactured using Corynex® has entered Phase I clinical trials in which human subjects are dosed.
By combining its Corynex® platform technologies for biopharmaceutical manufacturing with Ajinomoto Althea’s sophisticated technological capabilities and expertise in biopharmaceutical development and manufacturing, Ajinomoto Co. will further expand its biopharmaceutical development and manufacturing services to strengthen and promote the Ajinomoto Group’s advanced biomedical business and to contribute to the health of people worldwide.
Overview of Ajinomoto Althea
Pharmaceuticals manufactured using biotechnologies such as gene recombination. Biopharmaceuticals are expected to have potential applications for diseases that were previously untreatable, as well as high levels of safety and efficacy with minimal side effects. Examples include treatments for cancer and rheumatism, typified by therapeutic antibodies that utilize the immune function.
A contract expression service that applies advanced technology using a specifically developed bacterium, Corynebacterium glutamicum, to improve efficiency of the manufacturing process for biopharmaceuticals such as proteins and peptides.
3. Advantages of Corynex®
The system utilizes the gram-positive bacterium Corynebacterium glutamicum, which is non-endotoxic, non-sporulating and non-pathogenic. Biologically active target proteins are secreted directly into the growth medium with high purity thereby facilitating more efficient scale-up and transfer to manufacturing. Compared with conventional systems that use E. coli, Corynex® can achieve substantial cost reduction by simplifying the purification process.
Contract Development and Manufacturing Organization. A company providing contract process development and manufacturing services for drugs at the pre-clinical, clinical and/or commercial stage for pharmaceutical and other companies.
current Good Manufacturing Practice. A quality control system of the U.S. Food and Drug Administration for manufacturing and testing of pharmaceuticals and other products.
6. Advanced Biomedical Business
Refers to the market area where Ajinomoto Co. can utilize its technology related to amino acids, nucleic acids, and proteins. The technology specifically includes Ajinomoto Co.’s Corynex®, serum-free medium for animal cells to produce biopharmaceuticals, and regenerative medicine.
About Ajinomoto Co.
Ajinomoto Co. is a global manufacturer of high-quality seasonings, processed foods, beverages, amino acids, pharmaceuticals and specialty chemicals. For many decades Ajinomoto Co. has contributed to food culture and human health through wide-ranging application of amino acid technologies. Today, the company is becoming increasingly involved with solutions for improved food resources, human health and global sustainability. Founded in 1909 and now operating in 27 countries and regions, Ajinomoto Co. had net sales of JPY 1,185.9 billion (USD 9.87 billion) in fiscal 2015. For more about Ajinomoto Co. (TYO: 2802), visit www.ajinomoto.com.
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Ajinomoto Co., Inc. Public Communications Department; email@example.com