TY - JOUR T1 - Mycoplasma clearance and risk analysis in a model bioprocess JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2016.007054 SP - pdajpst.2016.007054 AU - Julie Wang AU - Sarah Johnson AU - Matthew Brown AU - Scott Lute AU - Cyrus Agarabi AU - Alena Dabrazhynetskaya AU - Vladimir Chizhikov AU - Kurt Brorson Y1 - 2017/01/01 UR - http://journal.pda.org/content/early/2017/01/14/pdajpst.2016.007054.abstract N2 - Mycoplasmas are a type of bacteria that lack cell walls and are occasional cell culture contaminants. In a biotechnology setting, because they can pass through 0.2 μm filters, mycoplasmas could pose a potential patient safety hazard if undetected contaminants from the production culture were not completely removed by downstream biotechnology manufacturing. In this study we investigated the ability of typical commercial monoclonal antibody (mAb) purification operations to clear and kill mycoplasmas, using Acholeplasma laidlawii as a model organism. Our spike/removal studies have shown that protein A column chromatography clears about 4-5 log10. Column regeneration effectively prevents A. laidlawii column carryover between chromatography runs. Moreover, low pH hold steps, typically implemented after protein A purification, effectively kill A. laidlawii using either pH 3.8 glycine or acetate buffers (LRV ≥5.30 and ≥4.57, respectively). Solvent/detergent (S/D) treatment, used in some processes instead of low pH hold, also completely kills highly-concentrated A. laidlawii (LRV ≥5.95). ER -