LIFECORE BIOMEDICAL, INC. \DE\

Lifecore Biomedical, Inc. is a contract development and manufacturing organization (CDMO) based in Chaska, Minnesota. The company specializes in the development, cGMP manufacturing, and aseptic filling of complex and highly viscous sterile injectable pharmaceutical drug and medical device products in syringes, vials, and cartridges. Lifecore is a leading U.S. manufacturer of pharmaceutical-grade, non-animal-sourced hyaluronic acid (HA), utilizing a proprietary, fermentation-based HA process developed in 1981. They manufacture HA in bulk form and for use in formulated and filled syringes and vials for customer injectable products, which are used in ophthalmic and orthopedic applications, among others. Lifecore also develops highly viscous non-HA-based sterile injectable products with customers for various applications. The company's product development services include analytical method development and validation, formulation development, sterile filtration, process scale-up, pilot studies, stability studies, process validation, and production of materials for clinical studies. Lifecore operates semi-automated Restricted Access Barrier Systems (RABS) and fully automated aseptic filling lines with isolators, supporting aseptic processing of both synthetic and biologic drug products. Manufacturing occurs across three cGMP facilities, where FDA-approved commercial drug and device products are produced. Lifecore holds certifications from regulatory agencies in Europe, Japan, Brazil, and the International Organization for Standardization (ISO). The company's HA capabilities were developed in the early 1980s, and its corporate name changed from Landec Corporation to Lifecore Biomedical, Inc. in 2022 to reflect its focus on the CDMO business.