Preventing Mycoplasma Contamination
Key learning objectives
Recent, high-profile contamination events involving major biopharmaceutical manufacturers have exposed the potential flaws in adopting a passive approach to defending against microbial threats, which can result in contaminated drug batches, regulatory intervention and in extreme examples even lead to tumbling share prices. Such contamination events cannot easily be detected or removed from a process once present. Therefore a multi-faceted preventative approach in addition to a thorough understanding of the manufacturing process is required to reduce the level of risk to a minimum.
The risk posed by Mycoplasma is discussed, together with how this may impact biopharmaceutical drug production processes. Current industry approaches to Mycoplasma control will be described with particular emphasis on the Parenteral Drug Association’s Mycoplasma Task Force and the resulting guidance derived from their work.
The practical application of microbiological detection methods, filtration technologies and process control techniques will be considered. Specific focus will be given to process control and its direct impact upon filter performance, relating to retention studies performed on a known Mycoplasma contaminant organism.