Sourcing and Processing Standards

Donor screening and recovery

Tissue originates from mothers who consent to donate at the time of a scheduled, full-term cesarean delivery. Donors complete a medical and social history review and undergo serology testing for communicable disease before any tissue is accepted into the program. Choosing to donate does not affect a mother's ability to also bank her baby's cord blood.

Recovery is performed by trained, licensed personnel, and tissue is processed within 48 hours of recovery. The supplier describes its processing as following FDA regulations along with AATB and AABB guidelines. We present that as the supplier's own characterization, and we encourage your team to request the underlying documentation rather than rely on a label.

Lot identity and release testing

Each tissue lot is assigned a unique lot identifier that follows the product from processing through shipment. Samples from every lot are sent to a third-party laboratory for sterility testing, and the lot is held in quarantine until that testing is complete and internal release criteria have been met.

If your clinic needs to trace a vial for recordkeeping or accreditation purposes, request the traceability records associated with that lot.

Cold chain and shelf-stable formats

Cryopreserved products are frozen using a slow-rate freezing method and stored at -80 degrees Celsius. They ship overnight on dry ice in validated containers so the cold chain is maintained from the supplier to your door.

Lyophilized (freeze-dried) formats are shelf-stable and do not require cryogenic storage. Reconstitution and handling instructions are provided in the product insert that accompanies each lot, and we recommend following that insert exactly rather than a general protocol.

Some lyophilized formats are exosome products. FDA states that there are no FDA-approved exosome products, and they are generally regulated as biologic drugs under section 351. Purchase and clinical-use decisions for these products belong to the physician, working with their own regulatory counsel.

Documentation available to verified accounts

Specifications referenced on this site reflect verified supplier documentation. Lot-specific certificates of analysis, donor eligibility summaries, and release records are available to verified accounts on request.

If you need a document to satisfy your own accreditation, insurance, or internal quality process, ask your account contact for that specific lot's paperwork before you order.

These products are not FDA approved or licensed for any disease or condition. Information here is for licensed healthcare professionals and is not medical or legal advice.