Anjinomoto Althea Expands High-Potency Mfg
Ajinomoto Althea, a San Diego, California-headquartered contract development and manufacturing organization, plans to open a new GMP production suite in its newly constructed high-potency products (HPP) commercial manufacturing facility located in San Diego, California.
Ajinomoto Althea took ownership of the new facility in May 2015 and phased construction and retrofitting commenced in January 2016. The company is offering process development and analytical services to clients from the new facility, and it will be open for GMP bioconjugation and complex formulation in November 2017. The firm anticipates full manufacturing services, including high-containment fill and finish, will commence in the fourth quarter of 2018. The facility is designed to develop, manufacture, test, and release HPPs including antibody drug conjugates, highly potent active pharmaceutical ingredients, and other formulations of highly potent drugs.
Ajinomoto Althea said it has also recently secured its first manufacturing contract for the new facility, which is located three miles from its current operations. 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 a commercial launch.
Source: Ajinomoto Althea