PRECISIONBIOLOGICS
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Cell biology

Perinatal tissue

Perinatal tissue refers to biological material associated with birth, such as umbilical cord, placenta and amniotic membrane, recovered with donor consent at the time of delivery rather than from an ongoing living donor.

The perinatal category is broad, covering several distinct tissue types that each have their own recovery methods, composition and processing considerations. Cord tissue, cord blood, placental tissue and amniotic membrane are all grouped under this term, but they are not interchangeable; confirm with a supplier which product category corresponds to which tissue type before purchasing.

Recovery of perinatal tissue generally includes a consent process with the donor at the time of a scheduled delivery, together with screening of medical and social history and serology testing for communicable disease before any tissue is released for processing. Confirm the specific donor-eligibility steps performed with any given supplier directly, since these are operational and eligibility steps that apply before a lot ever reaches characterization testing.

Because perinatal tissue describes the source, not a regulatory outcome, ask any supplier for donor eligibility documentation, recovery timing, and a description of the processing method used for the specific product, rather than assuming perinatal origin alone establishes a regulatory pathway. That determination is made per product and per intended use.

Buyers should know that "perinatal" describes tissue source, not regulatory category, so eligibility and processing documentation must be requested per product and per lot.

Sources

  1. 21 CFR 1271.10 - Are my HCT/Ps regulated solely under section 361 of the PHS Act ↗eCFR