Many different rapid microbiological methods (RMM) have been developed in recent years, although their acceptance and implementation in the pharmaceutical industry has been slow. To stimulate the integration of RMMs in the pharmaceutical industry, the Food and Drug Administration (FDA) introduced the Process Analytical Technology (PAT) initiative in 2004. A year later, the Encyclopedia of Rapid Microbiological Methods, edited by Michael J. Miller, was published. Miller, senior research fellow in the manufacturing and science department at Eli Lily, recruited many authors, mainly from highly recognized institutions in the United States, to contribute to the work.
The encyclopedia comprises three volumes, each with 17 to 18 chapters. Each chapter ends with short biographies of the authors. In the first volume, themes such as the history of microbiology, validation strategies, PAT, and the PDA Technical Report No. 33 are covered. Volumes two and three deal with different RMMs and include instrumentation and users’ and suppliers’ points of view. Volume two deals with growth-based methods and volume three mainly with nucleic acid-based techniques.
The title of the books, Encyclopedia of Rapid Microbiological Methods, is perhaps misleading, because it is not an encyclopedia (an encyclopedia is a book or set of books providing information on one or many topics and arranged in alphabetical order). Nevertheless, the books are a valuable source of information for anyone interested in the different RMMs that are available. Additional sources will be necessary to get an in-depth view of certain methods.
Volume one starts with an overview of the early history of microbiology. Biographies of important microbiologists such as Antonie van Leeuwenhoek, Lazzaro Spallanzani, Louis Pasteur, and Robert Koch are included. One of the most valuable chapters in volume one is Chapter 14, “The PDA Technical Report No. 33.” After the choice of rapid microbiological methods has been made, a critical next step is determining the strategy for implementation. Chapter 14 answers many questions and could be useful in strategy decisions.
Volume two explores methods currently in use and well-established in the pharmaceutical industry including the Vitek 2 system, Biolog, Microscopy, and ATP bioluminescence. A good deal of attention is given to ScanRDI, a method that combines fluorescent labeling of viable microorganisms with laser scanning detection. Because three chapters deal with the ScanRDI, repetition is inevitable. It is also questionable whether another three chapters are necessary to cover the Rapid Bacteria Detector (RDB) 3000, a fully automated, laser-based technology that uses the principles of flow cytometry.
Volume three covers methods such as fatty acid methyl esther analysis, mass spectrometry, ribotyping, sequencing, automated Rep-PCR, quantitative PCR for mycoplasma testing, microarray analysis, and others. One of the most interesting methods is explained in Chapter 9, 16S rRNA gene sequencing using the Microseq. Although the first part of this chapter is well written, the second part contains mainly the figures from the Microseq manual with minimal explanation. More technical information along with the figures would be useful for the increasing numbers of pharmaceutical companies interested in using this system for identification of bacteria and fungi.
The Hybrid-Mycoplasma Q-PCR is described in Chapter 14 of volume three. Although the rapid detection of mycoplasma is very important to the pharmaceutical industry, valuable information is missing. The chapter does not explain how many different mycoplasma species were actually tested in the assay described, for example. A theoretical 100% sequence identity of 60 species does not necessarily mean that all species will be detected.
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Overall, the three volumes are a good investment, providing a lot of valuable information. However, additional references are necessary for a thorough understanding of the methods. Though the books were published in 2005, many of the described techniques are still considered “new” to the pharmaceutical industry. Like many books published by PDA the price is on the high side.
The Encyclopedia of Rapid Microbiological Methods (Michael J. Miller, editor) is published by DHI Publishing, LLC, River Grove, IL, USA 2005. The hardcover edition is available from the Parenteral Drug Association (www.pda.org) at the member price of $795 ($989 for nonmembers, government Price $685).