Lifecore Biomedical CDMO Corporate Profile

Lifecore Biomedical CDMO
Lifecore Biomedical CDMO
3515 Lyman Blvd
Chaska, MN 55318
United States
Phone: (952) 368-4300
Website: www.lifecore.com
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.

YOU define the starting line.

We’ll help you reach the (fill) finish line, and beyond.

Lifecore has also been a leading producer of pharmaceutical-grade, non-animal-sourced sodium hyaluronate since 1981 when we developed our fermentation-based process. Since then, we have become the preferred viscoelastic supplier to ophthalmic market leaders and our products have been used in the treatment of more than 150 million patients worldwide.

CDMO Services:

  • Multiple vial, syringe, and cartridge configurations.
  • Expertise in complex formulations and highly viscous products (in excess of 100,000 cP).
  • Capability to support pre-clinical process development, clinical trial batches, and commercial scale-up.
  • End-to-end services for development, sterile filtration, aseptic fill/finish, packaging, and stability studies as well as in-process and release testing.

    • 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.

    • Company Description

    Lifecore Injectables CDMO is a U.S.-based Contract Development and Manufacturing Organization specializing in the development, fill/finish, and commercialization of sterile injectable pharmaceuticals, biologics, medical devices, and combination products. With a 40+ year regulatory track record and 20+ commercial products, Lifecore offers end-to-end services including formulation process development, aseptic fill/finish, analytical services, packaging, and stability studies.

    Additional highlights:

    • Annex 1 compliant
    • Isolator filling
    • Global certifications and registrations

    Company Background

    Lifecore was founded in 1965 and has 400+ employees and annual revenues exceeding $125 million in recent fiscal years. Senior leadership includes (President and CEO) Paul Josephs, (Chief Financial Officer) Ryan D. Lake (CPA), (Chief Commercial Officer) Mark DaFonseca, and (Executive Vice President, Quality and Development Services) Jackie Klecker.

    Facilities

    Lifecore has a three-site campus (248,000 square feet) in the Minneapolis, MN metropolitan area. Operations include pilot laboratory for process development, aseptic formulation and fill/finish suites, redundant analytical laboratories, stability chambers, and secondary and final packaging.

    Services and Capabilities

    Lifecore offers end-to-end services including formulation process development, aseptic fill/finish, analytical services, packaging, and stability studies. Our capabilities span easy-to-complex formulations including expertise with highly viscous products (exceeding 100,000 cP). We provide support across pre-clinical, clinical, and commercial stages. Lifecore is also a leading producer of pharmaceutical-grade, non-animal-sourced sodium hyaluronate which is used as an API and excipient.

    Content

    Lifecore Biomedical CDMO
    Lifecore Biomedical CDMO
    3515 Lyman Blvd
    Chaska, MN 55318
    United States
    Phone: (952) 368-4300
    Website: www.lifecore.com

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