Product Testing
Last quarter, we detailed the rigorous donor screening and testing we perform prior to accommodating any animals at Miracle Ranch (https://anicellbiotech.com/anicell-summer-2018-update/). We also made the case for treating our collection facility like a blood plasma facility–isolated from many of the communicable diseases that could be spread between horses in a traditional boarding facility. Our insistence on controlling the handling of tissue material through our supply chain, from the collection of amnion tissue to aseptic processing in our laboratory, guarantees an unbroken chain-of-custody among other quality assurance measures.
This quarter we will discuss the testing performed during the processing of the finished products. One of AniCell’s Core Values is Safely Extending ACTIVE life with Innovative Solutions; correspondingly, AniCell performs a quality control check at every stage of product processing. These quality checks include not only internal safety measures but also product testing done externally through third-party labs to ensure independent corroboration of our results. For our implantable products, these third-party labs test for both bacterial and fungal bioburden, LAL-endotoxins content, and any incidence of mycoplasma contamination. As for our biological bandage products such as BioScaff, StemWrap, and AniOcular, those products are sent off for terminal sterilization using Electron Beam Irradiation.
Our final installment in this series will discuss product efficacy and safety tracking treatment phase.
