Lifecore Biomedical

Lifecore Biomedical is a fully integrated Contract Development and Manufacturing Organization (CDMO) that offers extensive expertise in specialty formulation, aseptic filling, and final packaging of complex medical devices and injectable pharmaceuticals.

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Lifecore-Biomedical-1.png

Description

Lifecore Biomedical is a fully integrated Contract Development and Manufacturing Organization (CDMO) with expertise in specialty formulation, aseptic filling, and final packaging of complex medical devices and injectable pharmaceuticals.

Lifecore is also a leading producer of pharmaceutical-grade, non-animal-sourced sodium hyaluronate which is used as an API and excipient. We are a preferred viscoelastic supplier to ophthalmic market leaders and our products have been used in the treatment of more than 150 million patients worldwide.

Process Development and Fill/Finish Services
• Development, fill and finish of sterile injectables.
• Syringes, vials, and cartridges, including proprietary sterile filtration system.
• Expertise in highly viscous (exceeding 100,000 cP) and complex formulations.
• Pre-clinical through commercial support for virtual organizations to large pharma.
• Proven QMS supports: API & Excipient;Medical Devices;Drug & Combination Products;Biologic Products

Additional Services
• Extensive on-site biological, analytical, and physical testing with redundant labs.
• ICH stability studies.
• Range of packaging, handling, serialization and sterilization options.

Sodium Hyaluronate
• Research-grade, pharmaceutical-grade, hydrogels, and custom modifications.
• Broad range of average molecular weights for use in R&D, animal/tox studies, clinical studies, and commercial applications.
• U.S. DMF (FDA for drug and device) approved, EP-certified, and JP-compliant.

Type of Drugs Manufactured:

Small Molecule;Biologics;Medical Devices

CDMO Services:

Drug Product Formulation (FDF);Clinical Trials materials and logistics;Packaging;Regulatory Services;Analytical Development

No. of Manufacturing Facilities:

2

High Potent Products capabilities:

OEB 3

Facilities Locations:

North America

Regulatory Approvals for facilities:

FDA (United States);EMA (Europe);ISO;GMP;PMDA (Japan);Health Canada;ANVISA (Brazil)

Manufacturing Technologies:

Cartridges;Pre-Filled Syringes (PFS);Semi-solids;Sterile Vials

Certification
United States FDA, GMP, ISO, Brazil ANVISA, Europe EMA, Japan PMDA, Canada Health Canada

Capabilities

Contact Information

Website
Address
3515 Lyman Blvd, 55318, Chaska, MN, United States
Zip/Post Code
93455

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