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