LVV

Reference Standards & Analytical Reference Materials

• Quantitative HEK-293 Genomic DNA
• BSA for Protein Quantitation

USP-NF Monographs and General Chapters

• <1047> Gene Therapy Products
• <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• <85> Bacterial Endotoxins Test
• <1085> Guidelines on Endotoxin Test
• <87> Biological Reactivity Tests – In Vitro
• <88> Biological Reactivity Tests – In Vivo
• <1125> Nucleic Acid-Based Techniques -- General
• <1126> Nucleic Acid-Based Techniques -- Extraction, Detection and Sequencing
• <1130> Nucleic Acid-Based Techniques -- Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
• <1128> Nucleic Acid-Based Techniques – Microarray
• <1127> Nucleic Acid-Based Techniques -- Amplification
• <1027> Flow Cytometry
• <1040> Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies, in PF49(6)
• <1129> Nucleic Acid-Based Techniques – Genotyping (including SNP, STR, etc.)
• <1040> Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies, in PF49(6)
• <1071> Rapid Microbial Testing
• <1050> Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin