Lifecore Biomedical is a fully integrated CDMO offering expertise in specialty formulation, aseptic filling, and final packaging of both complex medical devices and injectable pharmaceuticals.

Lifecore has also been a leading manufacturer of pharmaceutical-grade, non-animal-sourced hyaluronic acid (HA) since 1981 when we developed our proprietary, fermentation-based HA process.

New Capacity

• Groninger 5-head SKAN isolator filling lines

Services

• Process development for all phases as well as technical transfer
• Formulation including chemical transformations, hydrogel cross-linking, and purification unit operations. Expertise in highly complex and viscous solutions. 
• Sterile filtration capability of highly viscous materials in excess of 100,000 cP
• Clinical and commercial filling for multiple sizes and configurations of vials, syringes, and cartridges. 
• Supply chain expertise to identify, source, and procure all raw materials including assistance with non-standard components 
• Variety of in-house labeling, packaging, handling, and sterilization options
• Extensive on-site in-process and batch release biological, physical, and analytical testing
• Analytical method development
• ICH stability studies

Product Types & Raw Material Components

• Hydrogels
• Microparticles
• Small molecules
• mAb fragments
• Proteins
• Modified Sodium Hyaluronate
• Polymers
• Emulsions
• Synthetic peptides

Depending on project requirements, equipment constructed from different materials such as glass, stainless steel, and single-use systems can be utilized.

Campus

Proximity to Minneapolis-St. Paul international airport. Located in Minnesota’s Medical Alley with room for expansion.

248,000 square feet among 3 sites with redundant on-site laboratories

Temperature-controlled WIP storage and warehousing