Lifecore Biomedical, Inc. (Lifecore), together with its subsidiaries, operates as an integrated contract development and manufacturing organization. The company provides services in the development, fill and finish of complex sterile injectable pharmaceutical products in syringes, vials, and cartridges.
Lifecore has become a leading U.S. manufacturer of pharmaceutical-grade, non-animal-sourced hyaluronic acid (HA) using the company's proprietary, fermentation-based HA process. The company manuf...
Lifecore Biomedical, Inc. (Lifecore), together with its subsidiaries, operates as an integrated contract development and manufacturing organization. The company provides services in the development, fill and finish of complex sterile injectable pharmaceutical products in syringes, vials, and cartridges.
Lifecore has become a leading U.S. manufacturer of pharmaceutical-grade, non-animal-sourced hyaluronic acid (HA) using the company's proprietary, fermentation-based HA process. The company manufactures HA in bulk form, as well as for use in formulated and filled syringes and vials for its customers’ injectable products used in treating a broad spectrum of medical conditions and procedures, including ophthalmic and orthopedic applications. The company has leveraged this expertise in HA fermentation, manufacturing, and aseptic formulation and filling to also develop highly viscous non-HA-based sterile injectable products with its customers for multiple applications.
Lifecore’s product development service capabilities 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. The company also operates semi-automated Restricted Access Barrier Systems (RABS) and fully automated aseptic filling lines with isolators. These systems support efficient and safe aseptic processing of both synthetic and biologic drug products. Manufacturing takes place across the company's three cGMP facilities, where it produces FDA-approved commercial drug and device products. The company has earned multiple certifications from regulatory agencies in Europe, Japan, Brazil, and the International Organization for Standardization (ISO). In addition, the company has implemented various process improvements to ensure improved productivity and discipline in key areas of its business.
During May 25, 2025, Lifecore continued to execute on the previously announced strategic initiatives to support higher performance as a CDMO.
Strategy
The key elements of the company’s strategy include maximizing existing customer business; advancing programs towards commercialization; and driving new business.
The company enhanced its business development strategy and increased its investment in sales and marketing to support brand visibility.
Sales and marketing
The company is focused on better aligning its internal resources to lead and manage existing and new clinical and commercial customer relationships in order to free up its business development team. The business development team is well-positioned to strategically expand the company's target market by increasing focus on large multinational pharmaceutical companies, later-stage clinical development programs, technology transfers of existing commercial programs, and a broader range of modalities. These efforts are aimed at driving new development programs into the company. To support this strategy, the company has increased its investment in sales and marketing to enhance brand visibility. Additionally, it has expanded its business development team by adding experienced sales talent focused on key drug development geographies in the United States and internationally.
Customers
During May 25, 2025, the company had revenues concentrations of 10% or greater from three customers, with those customers comprising 44%, 18%, and 10% of revenue.
Government regulation
Most of the company’s customers’ products are regulated by the Food and Drug Administration (FDA) and similar agencies in other countries.
In addition, Lifecore is subject to extensive and continuing regulation by the FDA, including compliance with current Good Manufacturing Practices (cGMP), which impose procedural and documentation requirements.
Accordingly, manufacturers like Lifecore must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.
History
The company was founded in 1965. It was incorporated in 1986. The company was formerly known as Landec Corporation and changed its name to Lifecore Biomedical, Inc. in November 2022.