Lifecore Injectables CDMO 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.

Process Development and Fill/Finish Services

• Development, fill and finish of sterile injectables.
• Syringes, vials, and cartridges.
• Pre-clinical through commercial support for virtual organizations to large pharma.
• Deep experience with precise process control for parameters such as shear, light, oxygen
• Proven ability to control timing of conjugation and other reaction steps.
• Specialized expertise in sterile filtration and filling of highly viscous formulations (exceeding 100,000 cP).
• Proven quality management system supporting drugs, biologics, medical devices, and combination products.
• Flexible onboarding of customer processes, methods, and equipment.

Additional Services

• Extensive on-site biological, analytical, and physical testing with redundant labs.
• ICH-compliant 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:

Drugs, biologics, medical devices, and combination products

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