Friday, 23 August 2013

The Role of Microbial Testing in Biopharmaceutical Manufacturing

"Critical to biopharmaceutical production is bioburden control and testing...The greatest risks to the product stream are;
  • Bacterial Endotoxins – A pyrogenic product (e.g., lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death.
  • Bacteria, yeast and mold – Microorganisms with the potential for growth in biopharmaceutical products. Gram-negative bacteria have the greatest potential for growth.
  • Mycoplasma – Microorganisms associated with plant and animal-derived materials lacking bacterial cell walls that have the ability to pass through 0.2 μm sterilising filters."
So writes Tony Cundell in an informative article titled "The Role of Microbial Testing in Biopharmaceutical Manufacturing".

To read more about the risks and risk mitigation measures, go to: Biopharm

Posted by Tim Sandle

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