ICH Q5A requires a demonstration that biopharmaceuticals intended for human use are free of viruses and other potential pathogens. Process safety assurance is achieved by an evaluation of both upstream and downstream manufacturing. Upstream strategies minimize risks by cell bank, raw material and cell culture harvest screening to rule out the presence of mycoplasma or viruses. However, all screening assays have LODs and there is still the potential for an undetected low-level contaminant to persist in a bioreactor, evading detection. Downstream manufacturing is evaluated for viral clearance or inactivation; however other potential microbes like bacteria, fungi or mycoplasma are monitored at vulnerable steps. Two recent technologies being investigated to minimize mycoplasma risk are UVc inactivation of cell culture media/post-capture product intermediate and small-pore filters for media pre-treatment. These two technologies have the ability to inactivate/remove parvoviruses and mycoplasma; however, there are few published reports on their effectiveness or potential deleterious impacts on the cell culture or the product. A more thorough understanding of the risks and benefits of these barrier technologies could support their introduction, help reduce the rate of contamination events and make for safer products.

Investigation of barrier technologies for clearance of mycoplasma in bioprocess solutions

253rd National Meeting (2017)

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