Our proprietary PūrAMP PROCESSTM decellularizing process that preserves and protects the healing properties of amnion maximizing the effective benefit to surgeons and AMPlifying the results for their patients.
Our processing facility is registered with the FDA and meets acceptable tissue bank standards, and is processed in accordance with GMP standards. Only tissue from donors with approved test results are evaluated for transplant. In addition all screening and testing results are reviewed according to the company’s quality systems.
Screening, collection and processing of amniotic tissue is done following strict safety procedures. All testing and safety standards meet or exceed FDA standards.
Donor tissue is recovered using the safest recovery techniques and sterile equipment to protect from contamination. Our careful multi-step PūrAMP process, carefully collects, preserves and protects the structural integrity of the amniotic membrane to maintain the tissue’s regenerative properties while expediting delivery to the lab.
Donor blood samples taken prior to or at the time of recovery were tested by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) and were found negative using FDA licensed tests for, at minimum:
• HBsAg: Hepatitis B Surface Antigen
• HBcAb: Hepatitis B Core Antibody
• HCVAb: Hepatitis C Antibody
• HIV 1/2/Ab: Human Immunodeficiency Virus
Types 1/2 and O Antibody
• HCV NAT: Hepatitis C Virus
• HIV NAT: Human Immunodeficiency Virus
• HBV NAT: Hepatitis B Virus
• RPR/STS or Equivalent: Syphilis
Donated tissue is immediately transported to the lab for processing following our careful collection processes. To comply with 21 CFR 1271.290 requirements, a Tissue Tracking/Transplant Record (TTR) is maintained to record chain-of-custody of every allograft. We record the patient information, the transplant facility name and address, the allograft tissue information and comments regarding tissue use on the TTR.
Our FDA registered lab begins processing immediately upon receiving the donated tissue to preserve integrity of the tissue. We maintain a highly controlled regulatory and quality assured processing environment with strict recovery techniques and sterile equipment to counter the risks of disease transmission at every step. Allografts meet the FDA’s stringent standards for minimally manipulated tissue.
CellGenuity’s allograft products are derived from amniotic tissues, which are typically discarded but instead have been donated by healthy consenting mothers delivering a full term healthy baby by scheduled, Cesarean Section. All donors are thoroughly screened for communicable diseases and a careful medical and social history is collected in advance to ensure that mothers meet all eligibility requirements.
All donors are pre-screened through a Strict regulatory and quality assurance compliance that includes an intensive medical review and prenatal evaluation and medical and social history screening.