Tissue Safety and Quality Assurance

AmnioGraft®, AmnioGuard™, and PROKERA®  are procured and processed according to Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP) regulations established by the United States Food & Drug Administration (FDA). Placental tissues are retrieved from donor mothers after elective cesarean section under full informed consent. The donor mothers are screened at delivery for infectious, malignant, neurological and autoimmune diseases and other exposures or social habits and also undergo a physical exam to determine the suitability for human transplantation. Donors are tested by a CLIA certified independent laboratory using FDA licensed test kits around the time of delivery and found to be serologically negative for, at minimum, the following tests:

  • HIV 1 & HIV 2, Antibody
  • HIV 1 Virus (NAT)
  • Hepatitis B surface antigen (HBsAg)
  • Hepatitis B core antibody (HBcAb)
  • Hepatitis C Antibody (HCVAb)
  • Hepatitis C Virus (NAT)
  • HTLV 1 & 2 antibodies
  • Syphilis (RPR)
  • West Nile Virus, WNV, (NAT)
  • Chagas (T. Cruzi)

Amniotic membrane is processed using a validated, proprietary method to produce AmnioGraft®, AmnioGuard™, and PROKERA®. The final product is released after microbiological testing yields no growth of microorganisms (aerobic, anaerobic, or fungal). AmnioGraft®, AmnioGuard™, and PROKERA® are preserved in a validated and patented storage medium.

Bio-Tissue’s Quality Policy

Bio-Tissue is committed to providing quality tissue & cell-based products that:

  • Are safe and effective
  • Bring value to users by delivering clinical, technological and innovative solutions globally.