The BE Biologic Process
BE Biologic only only uses human umbilical cord derived stem cellular tissues. The donations of umbilical cord tissue come from consenting, disease-free, healthy donors.
BE Biologic's provides a safe and reliable source for physicians to use human umbilical cord tissue regenerative medicine products that contain mesenchymal stem cellular tissues. Since this is a non-invasive therapy, it avoids the inherent risks of surgery such as infection, blood clot and the recovery period for both donor and patient.
Umbilical cord donation is regulated by the American Association of Tissue Banks (AATB) for quality, safety and ethics. In order to assure the product is safe, the tissues are taken from healthy donor volunteers who are rigorously screened for pathogens. As a result, the tissue is obtained during a non-invasive, simple procedure from informed consensual donors. The tissues donated are from safe, reliable hospital sources using strict ethical protocols.
BE Biologic's Stringent & Compliant Standards
The tissues are procured, processed, and tested in accordance with standards established by the American Association of Tissue Banks (AATB) and FDA requirements. Infectious disease testing is performed at a certified lab in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLA) and 42 CFT part 493 and the FDA. Tests are completed each step of the way to ensure the highest quality safety standards are maintained. Products are compliant under 21 CFR part 1271 and section 361 of the Public Health Services Act.
Each donor is tested for HBsAg (hepatitis B Surface Antigen), HBcAb (hepatitis B core Anti-body), 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), CMV, and HCV NAT (HCV Nucleic Acid Test).
All products are tested post-processing for endotoxins and to demonstrate the absence of bacterial, yeast and fungal pathogens. The products are quarantined until test results are received, reviewed and approved by scientists. It is only then, that they are released for production. They are periodically retested.
All testing results are reviewed by BE Biologic prior to release of our product. Considerable precaution with multiple steps are taken to help ensure the safety of products and meet all applicable compliance guidelines and standards established by the FDA.
A proprietary process is utilized which maintains the structural properties of Wharton’s Jelly of the human umbilical cord and creates a cryopreserved flowable sterile product without the use of enzymes or digestion. It is minimally manipulated and preserves the therapeutic elements of the mesenchymal stem cellular tissue, cytokines, growth factors, and other elements present in Wharton’s Jelly.