Sterility & Pathogens
Sterility & pathogen screening
Cell products must be tested for microbial contamination and screened for pathogens. Both donor and final product testing matter.
Testing
What sterility & pathogen reports should cover
Bacterial and fungal sterility testing on the final product
Mycoplasma testing
Endotoxin testing (LAL or equivalent)
Donor pathogen panel: HIV, HBV, HCV, syphilis, HTLV where applicable
Documented chain of custody from donor to processing
A clinic that cannot provide sterility documentation should not be administering live cell products.
Ask before you pay or travel
Send your stem cell offer or clinic documents for private review.