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Ajinomoto Althea Opens GMP Mfg. Suites

To develop and manufacture ADCs and HPAPIs

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By: Kristin Brooks

Managing Editor, Contract Pharma

Ajinomoto Althea, Inc. is opening a GMP production suite in its newly constructed High Potency Products (HPP) commercial manufacturing facility in San Diego, CA. Althea currently offers process development and analytical services 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, to begin in 4Q18.
 
Althea has also recently secured its first manufacturing contract for the new facility, which is 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 project will include technology transfer, analytical method implementation, process validation, and GMP Drug Product manufacture in preparation for commercial launch of the client’s therapeutic drug.
 
Jason Brady, Ph.D., senior director and business head, said, “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.”

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