All birth tissue products are obtained from C-section deliveries from normal, full-term pregnancies. Donors that consent to use of their birth tissues are carefully screened prior to the use of their tissues in manufacturing.
Comprehensive medical and social histories of the donors are obtained and tissues are procured, processed, and tested to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493.
Each donor is tested for HBsAg (Hepatitis B Surface Antigen), HBcAb (hepatitis B core Antibody), HCV (hepatitis C Antibody), HIV I/II-Ab (Antibody to Human Immunodeﬁciency Virus Types 1 and Syphilis detection test, HIV NAT (HIV Nucleic Acid Test), and HCV NAT (HCV Nucleic Acid Test).
All products are tested post-sterilization to demonstrate the absence of bacterial and fungal pathogens and are non-pyrogenic.