Vitti LabsTM is an industry leading manufacturer of human cellular and tissue-based products (HCT/Ps).


A Tissue Bank is so much more than processing. Tissue banking is about building a community of partners to ensure the safety of transplant recipients, donors, medical practitioners, and hospital staff. As a tissue bank, we are responsible for fulfilling the expectations of the tissue donors and the recipients through a strong ethical and regulatory practice.


Vitti LabsTM only accepts bio-ethically donated human birth tissue from healthy consenting mothers in the United States who have passed a comprehensive medical background check, blood screenings, and have full-term, live, C-section births. In addition, we only work with tissue procurement organizations within the United States who use collection techniques that follow the AATB guidelines, prioritizing the health and safety of the mother and baby above procurement. We strive to have an FDA and AATB compliant supply chain and the highest quality procurement.


Minimal Manipulation: Vitti LabsTM processes HCT/Ps in compliance with minimal manipulation guidelines to be regulated as a 361 HCT/Ps.

For structural tissue, minimal manipulation means that the processing of the HCT/P does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement following 21 CFR 1271.3(f)(1).

Original relevant characteristics of structural tissues generally include the properties of that tissue in the donor that contribute to the tissue’s function or functions.


Testing & Guidelines: We exceed industry standards for lot testing. Every lot manufactured is sent for sterility, endotoxin, and environmental testing by a third-party laboratory that is a global leader in pharmaceutical, cosmetic, and environmental testing.

  • USP 71 Sterility Guidelines (All Fungus, Mold, Yeast, Bacteria) in accordance with AATB and FDA guidelines.
  • Endotoxin guidelines and environmental testing in accordance with AATB and FDA guidelines.
  • USP 1116 Environmental Controls in accordance with AATB and FDA guidelines.
  • Viruses, blood, and tissue borne pathogens in accordance with AATB and FDA guidelines including HIV, HBsAg, HCV, HBc Total, HTLV I/II, RPR, HIV/HCV/HBV Ultrio, WNV NAT, CMV Ab, Zika NAT, Lyme Disease, Epstein-Barr Virus, E.coli, Candida, and COVID-19.

* For a complete list of testing please contact your representative.