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Subsequently, bacteria and endotoxins are translocated into the liver through the portal vein, activating the TLR4/NF-B signaling pathway of liver Kupffer cells, and promoting the liver inflammatory cascade and fibrosis development (Jiang and Schnabl, 2020)

The EUs Annex 1, revised in 2022, specifically requires manufacturers to implement a formal CCS program that covers all critical control points for maintaining sterility, including environmental cleaning and the transfer of materials within the facility