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.
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Key Learning Objectives
Understand the potential threat of Mycoplasma
Understand the guidance from industry bodies
Understand how detection, filtration and process control technology can prevent contamination
Understand how to apply these technologies to a biopharmaceutical manufacturing process
This webinar is presented by Andy Kelly, Product Manager (Life Sciences) and Nick Hutchinson, Market Development Manager (Life Sciences) at Parker domnick hunter.
This webinar covers the risks posed by adventitious microorganisms and presents practical strategies for implementation of control technologies to provide a robust approach to preventing contamination events in your bioprocess
Implementing a Risk-Management Based Approach to the Prevention of Mycoplasma Contaminations