VITTI LABS™ IS A TISSUE BANK WHICH FOCUSES ON LIFE SCIENCE RESEARCH, DEVELOPMENT, AND MANUFACTURING.

  • AATB ACCREDITED

  • CGMP CERTIFIED

  • FDA REGISTERED

It’s our life’s work to create breakthrough therapeutics resulting in measurable, impactful solutions that positively transform lives. 

  • We believe research is invaluable.

  • We engage in peer, physician, and patient collaboration.

  • We respect and uphold regulatory guidelines through a proactive culture.

  • We establish and follow rigorous protocols and procedures to ensure high-quality products, safety, and consistency. 

  • We prove our processes with above industry standard testing by third-party labs. 

Regulations: Vitti Labs™ implements and maintains quality and regulatory assurance in alignment with FDA (Federal Drug Administration) regulations.  We do so by building strict protocols to uphold these requirements. In addition, we perform FDA mock audits annually. Additionally, we are AATB (American Association of Tissue Banking) accredited, cGMP (Current Good Manufacturing Practices) certified, follow GTP (Good Tissue Practices), and WHO (World Health Organization) protocols and procedures to meet applicable requirements.

Sourcing: Vitti Labs™ only accepts bio-ethically donated 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.

Testing Guidelines 

Testing + Validation: We exceed industry standards for lot testing. 20% of 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.

 

VITTI LABS™ TESTING GUIDELINES

1. USP 71 Sterility Guidelines (All Fungus, Mold, Yeast, Bacteria) in accordance with AATB and FDA guidelines.

2. Endotoxin guidelines and environmental testing in accordance with AATB and FDA guidelines.

3. 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.