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Microbiology Consultants LLC

 

The limitations of the colony-forming unit in microbiology

6 January 2016 | By Tony Cundell, Microbiological Consulting LLC

The recent revision to USP General Informational Chapter Validation of Alternative Microbiological Methods that became official on December 1, 2015 contained a section discussing the limitations of the colony-forming unit (CFU) in terms of enumerating only those microorganisms that readily grow on solid microbiological media. The section highlights its inappropriateness…

The Encyclopedia of Rapid Microbiological Methods: The new fourth volume discusses technologies, regulatory acceptance and validation case studies

13 June 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and rapidmicromethods.com

This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies,…

Improving the quantitation of live antigens used to produce rabbit generated serotype specific antiserum

21 February 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC, Silvia Fragoeiro, Ananthi Ramachandran and Paul van Empel MSD Animal Health

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…

Rapid micro methods and the next generation in ATP bioluminescence

25 October 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC and Noe Miyashita, Researcher, Hitachi Plant Technologies, Ltd

This is the fifth paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. As many of you know, I am always on the lookout for the next generation of rapid microbiological method (RMM) technologies and solutions. In this article, I…

Opportunities for rapid methods discussions: where the experts are meeting!

3 September 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the fourth paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Over the past few years, a number of professional meetings have focused on strategies and case studies for the validation and application of rapid microbiological methods (RMM).…

Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations

10 July 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the third paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Rapid sterility testing is one of a number of applications that novel microbiological technologies afford the pharmaceutical industry. RMM technologies have already been validated and implemented for…

Rapid micro methods and EMA’s post approval change management protocol

26 April 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the second paper in our continuing series on Rapid Microbiological Methods that will appear in European Pharmaceutical Review during 2012. In my last article, we discussed a number of myths or misconceptions associated with the validation and implementation of rapid microbiological methods (RMMs). In fact, most RMM myths…

New year, old challenges!

28 February 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the first of many articles in our continuing series on Rapid Microbiological Methods that will appear in European Pharmaceutical Review during 2012. For the past two years, I have enjoyed sharing with you a broad range of topics associated with the validation and implementation of rapid microbiological methods…

Detection of microorganisms using micro-electro-mechanical systems (MEMS)

13 December 2011 | By Michael J. Miller, President, Microbiology Consultants

This is the sixth and final article in our series on Rapid Microbiological Methods (RMMs) that have appeared in European Pharmaceutical Review during 2011. In our last article, we reviewed the world of nucleic acid amplification technologies, including PCR-DNA amplification, RNA-based reverse-transcriptase amplification, 16S rRNA typing and gene sequencing for…

Detection of microorganisms using optical spectroscopic-based rapid method technologies

31 August 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the fourth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Previously, we discussed a number of cellular-component rapid microbiological methods (RMMs), such as ATP bioluminescence, fatty acid analysis, MALDI and SELDI time of flight mass spectrometry, Fourier transform-infrared…