Similar to the screening process performed by tissue banks, donors are tested for HIV, HTLV, Hepatitis B, Hepatitis C, Syphilis and CMV. Kimera Labs® goes beyond these FDA requirements by testing for these viruses and additional testing for Zika, EBV, Hepatitis E, HHV6, HHV7, HHV8, HSV1, HTLV1, HTLV2, BKV, and Norovirus. Exosomes produced by Kimera Labs® remain under quarantine prior to release for research use until testing confirms that they are negative for these pathogens.
In addition to understanding the rigorous screening and testing process for pathogens, it is important to note that placental mesenchymal stem cells are not a natural reservoir for these viruses. Any possible risk of contamination of donor tissues despite rigorous screening is furtherer reduced during the MSC culture and exosome isolation process. Finally, sterility and endotoxin assays are performed after the final stage of production to confirm the absence of any infectious agents.