IPS was selected by Ajinomoto Althea, Inc. (“Althea”) to design aseptic filling suites at their new manufacturing facility in San Diego, California 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 57,000sf facility will offer comprehensive 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 US-based location, which will become a model for the industry in safely manufacturing potent biopharmaceutical products.
IPS is the proven leader in advanced aseptic processing facilities and barrier technology, with internationally recognized experts at the forefront of risk-based barrier technology design, industry trends, and regulatory requirements. “It’s exciting for IPS to be a part of this important project that will provide new therapeutics to patients around the world,” said IPS President of the Americas Mark Butler. “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.”
To read more go to http://ipsdb.com/pdfs/IPS-Provides-Engineering-Solutions-To-Althea.pdf