Innovation in Biologics
Our proprietary PūrAMP PROCESSING™ preserves the products that can be used in a wide range of surgical and non-surgical applications.
CellGenuity only utilizes gestationally derived biologics from healthy consenting mothers who have delivered a full term healthy baby during a scheduled, elective Cesarean Section. All donors are subject to strict regulatory and quality assurance compliance, medical and social history screening, informed consent, and medical records history review.
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 required tests for:
- 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
Donor tissue is recovered using the safest recovery techniques and sterile equipment to protect from contamination. Our careful multi-step “DAY-ONE” process, carefully collects, preserves and protects the native proteins and the gestational tissue maintains the tissue’s regenerative properties while expediting delivery.
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.
Timing matters. Our production 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.
All screening and testing results are reviewed according to the company’s quality management system, which is designed to meet the requirements specified in the FDA’s Good Tissue Practice regulations and in the standards of the American Association of Tissue Banks. All donor screening and testing records are reviewed and accepted by QA personnel. Only tissue from donors with approved test results are released.
All policies and procedures for donor screening, serologic, and microbiologic testing comply with all current standards and regulations established by the FDA.
There have been no reported adverse reactions associated with any CellGenuity products.