List Labs can perform both in process, QC analytical assays, and release testing for products. For Live Biotherapeutic Products, List Labs performs viability assays by colony forming units (CFU) or live/dead staining, identification, total cell counts, moisture, bioburden using USP<61> and UPS<62>, and bioactivity assays. We also have a number of analytical techniques to characterize protein and toxin products including native and SDS-PAGE, Western Blot analysis, protein concentration, endotoxin, KDO and phosphate analysis, ELISA, HPLC, thin layer chromatography, cell cytotoxicity assays, cytokine assays, fluorescent and colorimetric enzyme assays.
Through contract services, we offer a highly sensitive assay to detect low levels of botulinum neurotoxin type A (BoNT/A) in complex matrices and diluted plasma. We also have a sensitive and specific assay for detection of anthrax lethal factor (LF) in plasma.
For further information on QC analytical capabilities, see the following link: [link]