The ratio of nicotinic acid to nicotinamide as a microbial biomarker for assessing cell therapy product sterility
Jiayi Huang, Cui Liang, Meenubharathi Natarajan, Paul W. Barone, Jacqueline M. Wolfrum, Yie Hou Lee, Scott A. Rice, Stacy L. Springs
Abstract
, significant increase of NA to NAM ratio was detected using LC-MS after 18.5, 12.5, and 24.5 h, respectively. In contrast, compendial sterility test required >24 h to detect the same amount of these three organisms. In conclusion, the NA to NAM ratio is a useful biomarker for detection of early-stage microbial contaminations in CTPs.
Topics & Concepts
Bacillus subtilisMicroorganismBacteriaMicrobiologySterilityBiomarkerCandida albicansCellBiologyChemistryNicotinamideInoculationFood scienceBiochemistryBotanyImmunologyEnzymeGeneticsVirus-based gene therapy researchBacillus and Francisella bacterial researchViral gastroenteritis research and epidemiology