Complete Intra-Laboratory Validation of a LAL Assay for Bacterial Endotoxin Determination in EBV-specific Cytotoxic T Lymphocytes
Molecular Therapy — Methods & Clinical Development（2021）
Key words
advanced therapy medicinal products,ATMPs,endotoxins,qualification,method validation,Limulus amebocyte lysate,LAL,failure mode and effects analysis,FMEA,GMP,good manufacturing practices
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