Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and Technology (ASAT) at Genentech.
With companies striving to produce cost-effective and high‑quality therapeutics, utilising the most efficient methods possible has become a critical focus. Thus, the lengthy incubation periods needed with traditional culture‑based microbiological monitoring techniques have long been a source of frustration. The introduction of alternative and rapid microbiological methods (ARMMs), without such extensive time requirements, is therefore helping companies overcome such limitations. However, the potential benefits of ARMM technologies are not limited to time saving.
One ARMM currently under investigation is the biofluorescent particle counter (BFPC), which detects the fluorescence of components in microbial cells to provide a measure of the bioburden level within air or water samples.1 Unlike their traditional counterparts, BFPCs gather data continuously and in real time, enabling them to act as a process analytical technology (PAT). Additionally, since culturing the organisms is not necessary for detection, BFPCs can detect viable but non-culturable (VBNC) microorganisms, which is believed to provide a more accurate measure of microbial contamination.1,2 Such systems have also often been found to have higher sensitivity than traditional methods.
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