
LIFECORE BIOMEDICAL CLINICAL & COMMERCIAL CDMO
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
CONTACT INFORMATION
Lifecore Biomedical
3515 Lyman Blvd
Chaska, MN 55318
UNITED STATES
Phone: +1 (952) 368-4300