Ajinomoto Bio-Pharma (AJINOMOTO ALTHEA INC.)

Company Overview

Ajinomoto Althea Inc. (Althea) is a fully integrated contract development and manufacturing organization that provides clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies. Althea is capable of supporting early-stage clinical requirements through commercial manufacturing. It has expertise in aseptic filling of drug products into vials and syringes, and its focused experience and capabilities make it one of the industry’s leading organizations for cGMP microbial-based manufacturing of recombinant proteins and plasmid DNA. Althea’s service offerings include upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.

Althea is a fully owned subsidiary of Ajinomoto Co., a global manufacturer of high-quality seasonings, processed foods, beverages, amino acids, pharmaceuticals and specialty chemicals. Ajinomoto acquired Althea to expand the business for biopharmaceuticals manufacturing in the U.S. market by combining Ajinomoto’s experience in biotechnology with Althea’s sophisticated technology, experienced personnel and expertise in cGMP manufacturing.

Althea has extensive experience in microbial biologic manufacturing, with an impeccable regulatory track record. The company has produced more than 250 cGMP cell banks and more than 300 cGMP lots of bulk drug substance. With five formulation suites and five fill/finish suites, the company has filled more than 2,100 lots of finished cGMP products. It is strengthening its capabilities to become a U.S.-based provider for high-containment ADC bio-conjugate manufacturing and HPAPI fill/finish services.