Nontuberculosis mycobacterium contamination of a mammalian cell bioreactor process for biologics manufacture

CASE STUDY A bulk harvest from a mammalian cell bioreactor process was submitted to the authors for evaluation in a 28-day in vitro adventitious virus screening assay as part of an investigation of a bioreactor problem at a biologies manufacturing site. IMPLICATIONS FOR THE INDUSTRY The nontuberculosis mycobacteria appear to represent a potential risk to the biopharmaceutical industry, due to their propensity for forming biofilms, their ability to proliferate in water under relatively low nutrient conditions, their resistance to typical water disinfection methods, and their relatively slow growth in nutrient media (2-5).