Quality at Ossium

Ossium GMP products come from rigorously selected donors and the final cell preparations are tested for sterility, viability, and immunophenotype. Our research use cells are prepared from a diverse donor pool by the same team that develops our GMP methods.

Quality System Elements

Ossium’s quality system is based on strict regulatory requirements and industry best practices. We follow current Good Manufacturing Practices (GMP) guidelines that include:

    • Qualifying donors, vendors, and suppliers
    • Auditing internal processes and external partners
    • Documenting data and controlling records
    • Developing, validating, and maintaining procedures
    • Training and qualifying staff
    • Monitoring equipment, supplies, and environment
    • Managing deviations and planned variances

Certifications and Licensure

The Ossium Health testing laboratory has maintained CLIA certification since 2019. The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA), which covers ~260,000 laboratory entities.

Facilities

Our ~34,000 square foot facility in Indianapolis, IN includes:

    • Clean room production suites
    • Quality control and CLIA certified testing laboratories
    • Cryogenic storage facilities
    • Warehousing and supply control facilities
    • Segregated research and development unit (complete with segregated supply storage and cryogenic storage)
    • Office/administrative space, and a facility support area.

Ossium’s core processing operations are conducted in ISO 5 Biological Safety Cabinets (Class II BSC) within ISO 7 Clean Rooms.

Donation Process

All Ossium donors are consented and screened through local Organ Procurement Organization (OPO) partners.  OPOs screen donors based on both organ donation requirements and Ossium’s bone marrow donation criteria before submitting donors to Ossium for final determination of eligibility.  If a donor is accepted, highly trained OPO staff recover the tissue and ship it to Ossium for processing.  Rigorous processes are followed from beginning to end to ensure proper authorization, testing, screening, and tracking.