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LLC - Articles and news items
Improving the quantitation of live antigens used to produce rabbit generated serotype specific antiserum
This is the first paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. Flow cytometry represents one of a variety of viability-based RMM technologies that are currently available to the pharmaceutical industry. In flow cytometry, individual particles are counted as they pass through a laser beam in a very narrow flow cell.
This is the second in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. In my last article, I provided an overview of growth-based rapid microbiological methods (RMMs). This was a good place to start my review of RMM technologies, as most of us continue to use conventional agar and liquid medium for the growth of micro – organisms. In the current article, I will significantly depart from growing microorganisms to the direct detection of microorganisms using viability-based technologies, which will include flow cytometry and solid phase cytometry.
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Last year, I provided an overview of rapid microbiological methods (RMMs), including validation strategies, regulatory expectations, the technical and quality benefits of RMMs as compared with conventional techniques, and an overview of a variety RMM presentations and plenary sessions during the 5th Annual PDA Global Conference on Pharmaceutical Microbiology.
During the year I also provided updates on what was new and noteworthy in the world of rapid methods, through my blog on www.rapidmicromethods.com. The response to this series was so overwhelming, I was asked to repeat the series again in 2011. Of course, I couldn’t resist (actually, my response to continue to provide guidance on RMMs was quite rapid!). As there are literally dozens of different RMM technology platforms, and just as many applications that they can be used for, it was obvious that this series would need to demystify the task of matching the right rapid method with the right application. Therefore, it is necessary to review the types of systems that are currently available, and those that are in development.
This is the sixth and final paper in a series of articles on rapid microbiological methods that have appeared in European Pharmaceutical Review during 2010. Over the past year, we have explored the world of rapid microbiological methods (RMMs), focusing on validation strategies, regulatory expectations, and the technical and quality benefits of these novel systems as compared with conventional techniques. It should be obvious by now that RMMs will significantly impact the future of microbiology within the pharmaceutical and biotech industries. But don’t just take my word for it.
This is the fifth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. In my previous four articles, I have provided an overview of the benefits of rapid microbiological methods (RMMs) as compared with conventional methods, validation strategies and regulatory perspectives on the implementation of RMMs, especially from the US FDA and the European Medicines Agency. Some regulatory authorities rely on the published literature as a means of staying current with regard to new technologies that are being introduced, in addition to which companies are implementing these technologies in their manufacturing facilities.
This is the fourth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Believe it or not, today’s regulatory authorities encourage the use of rapid microbiological methods (RMMs), and when applicable, they have put policies in place that provide guidance on how to get a RMM approved. Because there are different regulatory perspectives on RMM implementation, a company should understand what each regulatory body expects with regard to validation, submission and implementation strategies. In my last article, I discussed a number of RMM implementation perspectives from the U.S. Food and Drug Administration (FDA). In this article, I will focus on the European Medicines Agency (EMA) and their expectations on the introduction of new RMM technologies.
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