Quality and regulatory compliance are foundational to everything we do. Ponya Therapeutics operates within a robust framework designed to ensure the safety, integrity, and traceability of every tissue allograft.
Our operations are conducted in FDA-registered facilities and align with current Good Tissue Practices (cGTP) and Good Manufacturing Practices (GMP) compliant, supported by comprehensive quality systems and controlled documentation. From donor screening and eligibility determination through processing and distribution, each step is governed by established procedures and regulatory requirements.
We maintain validated processes, environmental monitoring programs, and rigorous quality controls to ensure consistency across all stages of manufacturing. Full traceability is embedded throughout our systems, enabling every graft to be tracked from donor to final use.
At Ponya, our commitment to quality extends beyond compliance – it is a continuous effort to uphold the highest standards of safety, reliability, and trust for the providers, partners, and patients we serve.
“(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a) Is for autologous use;
(b) Is for allogeneic use in a first-degree or second-degree blood relative; or
(c) Is for reproductive use.”
21 CFR 1271.10(a)
According to 12 CFR 1271.3(f),
“Minimal manipulation means:
(1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; and
(2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.”
Our gentle processing methods were designed to retain the structural integrity of the amniotic membrane with minimal loss of any internal components.
According to 21 CFR 1271.3(c),
“Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.”
Ponya Therapeutics’ amniotic membrane derived products provide a protective covering to the wound bed and protection from the outside environment similar to the placenta providing a covering and protection to the developing fetus.
Ponya Therapeutics mantains complete forward and backward traceability. Each HCT/P is given a unique identifier that includes the lot and serial number that can be traced back to the donor. Each donor has a unique ID that is linked to the lot number so that the donor can be traced to the lot.
All external testing laboratories performing donor screening and testing for relevant adventitious agents are certified by CLIA to perform tests of moderate or high complexity. Donor eligibility is determined by Ponya’s Medical Director and all Ponya products are released with a Certificate that provides a Summary of Records, as required by 21 CFR 1271.55.
