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Rapid Microbiological Methods (RMMs)

 

Fast quantitative 2D NMR for quantifying analytes in complex mixtures
Fast quantitative 2D NMR for quantifying analytes in complex mixtures
article

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…

article

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…

collaboration
collaboration
article

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).…

Reducing microbial contamination via sterile risk assessment
Reducing microbial contamination via sterile risk assessment
article

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…

Article 3: The implementation of rapid microbiological methods
Article 3: The implementation of rapid microbiological methods
article

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…

article

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 cellular component-based rapid method technologies
Detection of microorganisms using cellular component-based rapid method technologies
article

Detection of microorganisms using cellular component-based rapid method technologies

20 June 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the third 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 viability-based rapid microbiological methods (RMMs), such as flow and solid-phase cytometry. In this article, we will review some of…

Reducing microbial contamination via sterile risk assessment
Reducing microbial contamination via sterile risk assessment
article

Overview of rapid microbiological methods evaluated, validated and implemented for microbiological quality control

19 April 2011 | By Oliver Gordon, Jennifer C. Gray, Hans-Joachim Anders, Alexandra Staerk & Oliver Schlaefli, Novartis Pharma Stein AG and Gunther Neuhaus, University of Freiburg

The risk for patients through spoiled or otherwise adulterated pharmaceuticals has been acknowledged for many centuries and led to the establishment of Good Manufacturing Practice (GMP) and pharmacopoeial guidelines. Besides chemical purity, pharmaceuticals also have to meet microbiological standards, the latter primarily depending on the administration route. Drug products which…

article

Article 1 Rapid microbiological methods 2011

16 February 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC

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,…