IPS-Integrated Project Services, a provider of engineering, procurement, construction management and validation (EPCMV) services, was selected by Ajinomoto Althea to design aseptic filling suites at their new manufacturing facility in San Diego, CA to support the growth of the company’s fill and finish capabilities.

To meet client and industry demand, Althea expanded operations to include manufacturing of highly potent drug products as well as antibody drug conjugates (ADCs) by developing a new state-of-the-art facility. Their new facility has been designed for safe handling and manipulation of highly potent compounds with very low OEL (occupational exposure limit), while maintaining aseptic conditions and cGMP compliance. The new 57,000 square foot facility will offer services from formulation to fill-finish and will accommodate all stages of development from pre-clinical production through commercial supply. The manufacturing areas support bioconjugation, formulation, purification, quality control, and aseptic filling including lyophilization.

IPS provided the conceptual and detailed design services and evaluated previous construction plans to ensure operational effectiveness. Althea’s completed facility will offer a simplified manufacturing supply chain by providing conjugation and fill finish services at a single U.S.-based location, which will become a model for the industry in safely manufacturing potent biopharmaceutical products.

“It’s exciting for IPS to be a part of this important project that will provide new therapeutics to patients around the world,” said Mark Butler, president of the Americas, IPS. “Bringing our expertise in the biopharmaceutical industry to support a leading contract development and manufacturing organization as Althea helping people live longer and healthier lives is what drives IPS and our employees.”