Ajinomoto Althea, Inc. Opens Manufacturing Suites in New High Potency & Antibody Drug Conjugate Commercial Facility

Ajinomoto Althea, Inc. recently announced it will soon open a GMP production suite in its newly constructed High Potency Products (HPP) commercial manufacturing facility located in San Diego, CA. Althea took ownership of the new facility on May 1st, 2015 and phased construction and retrofitting commenced in January 2016. Althea is currently offering process development and analytical services to clients from the new facility and will be open for GMP bioconjugation and complex formulation in November 2017. Althea anticipates full manufacturing services including high containment fill and finish will commence in Q4 2018.

Althea has also recently secured its first manufacturing contract for the new facility located just three miles from their current operations. The new Althea facility is uniquely designed to develop, manufacture, test, and release HPPs including Antibody Drug Conjugates (ADCs), Highly Potent Active Pharmaceutical Ingredients (HPAPIs), and other complex formulations of highly potent drugs.

The terms of the deal are confidential, but the scope of the project will include technology transfer, analytical method implementation, process validation, and GMP Drug Product manufacture in preparation for commercial launch of the client’s key therapeutic drug.

Jason Brady, PhD, Sr. Director and Business Head, states, “the opening of our first production suite and signing of our first major contract is a clear sign that our investment which addresses the high containment manufacturing needs of our clients will positively impact Althea’s growing business. There is limited capacity in the marketplace and customers are eager to secure availability in a state-of-the-art facility managed by a company with an outstanding quality track record.”

Althea is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. 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, Althea offers comprehensive development services including: upstream and downstream process development, analytical development, complex formulation, product release and ICH-compliant stability testing. 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. Althea also has an innovative and proven recombinant protein expression technology called Corynex® technology. For more information visit www.altheaCMO.com.