A new GMP production suite at the High Potency Products (HPP) facility is in the works.
California-based biopharmaceutical CDMO Ajinomoto Althea said that it will soon be opening a new GMP production suite at its recently completed High Potency Products (HPP) facility, which it acquired in 2015 and began retrofitting and upgrading the following year.
Ajinomoto Althea said it is currently offering process development and analytical services to its clients through the new facility scheduled to open in November. The company anticipates full services, including manufacturing and sterile fill/finish operations, will commence in by the end of 2018.
According to Ajinomoto Althea, the new facility is designed to handle HPP products and to manufacture, test and release them along with highly potent active pharmaceutical ingredients, antibody drug conjugates, and other complex formulations. The company said it has already secured a contract for the new facility, which is located in near proximity to its other operations in San Diego.
Sr. Director and Company Spokesman, Jason Brady 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."
The terms of the new contract are confidential, said Ajinomoto Althea, but the overall scope of the customer’s drug development project will include technology transfer, analytical method implementation, process validation services and GMP-based drug product manufacturing.