From Discovery to Commercialization

Ossium supports customers from discovery through commercialization by supplying both clinical and research grade human cells. We’ve invested in building a state-of-the-art production facility, a team with deep CMC expertise, and comprehensive donor qualification capabilities so that you can focus on your research goals.

View products

GMP products

GMP cells are suitable for use in IND-approved clinical studies. Ossium maintains an FDA Master File and may grant reference letters to customers filing INDs upon request and review.

Research use only (RUO) products

Intended for research use only.

Quality and facilities

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 by the same team that develops our GMP methods.

  • 34k sq ft

    Production facility in Indianapolis, IN

  • CLIA

    Certified testing laboratory since 2019

  • ISO 5

    Biological safety cabinets within ISO 7 clean rooms

  • OPO

    Donors consented and screened through OPO partners

Quality system elements

We follow current Good Manufacturing Practices (GMP), including:

  • 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

Request a quote

Tell us which cells you need and how many, and we’ll send you a quote.

Reach us at(833) 4OSSIUM [833-467-7486]
[email protected]

  • This field is for validation purposes and should be left unchanged.
  • First and last name.
  • We reply to this address.
  • Company, institution or organization.
  • What cell types are you interested in?* (required)
    Choose all that apply.

Protocols and sample CoAs