The latest trends in pharmaceutical microbiology

Media manufacturers have started to market new microbiological media; either selective for BCC, or media that will recover BCC (but is not selective). These media can be useful but should be evaluated to ensure whether they are or are not selective for BCC. In some cases, the existing types of media (eg, TSA, R2A, SDA) have also been shown to grow these organisms at the same rate.

The evaluation of rapid microbiological methods has led to the utilisation of other types of media than those that were traditionally used. One such example is the use of Schaedler blood agar with rapid sterility testing in the Milliflex rapid.⁷ 

Facilities used to manufacture antibiotics need to be able to neutralise the monitoring media utilised to ensure that if microorganisms are present they can be recovered. Different enzymes are needed depending upon the type of antibiotic. Additionally, sterility testing of antibiotics also requires neutralisation to allow contaminants present to grow. Another advance in culture media relates to use of enzymes to inactivate various antibiotics. This is important to ensure Traditionally, β-lactamases were readily available to add to culture media. Today, a variety of media are available with the enzymes already incorporated into the media, eg, specific betalactamases for use with penicillins, cephalosporins (first to fifth generation) and carbapenems.⁸ 

Alternative or rapid microbiological methods

While many rapid methods have been introduced in the past 20 or 30 years, the route to implementation has been slow. It does not diminish the importance of these methods. It appears that the implementation of these systems in water testing is moving forward. This allows for almost all water testing to be released in real time. While endotoxin testing is not necessarily real-time, the handheld units can provide results in near-real time.

Identification systems

[bf] There have been many advances in the methods available for “rapid” identification testing. Today, both identification testing and strain typing can be performed using automated systems. 

Pathogen detection

Sandle⁹ provides an overview of several new methods for rapid pathogen detection. He indicates that rapid is probably not a good term to use, as it is subjective. It is probably better to refer to these methods as an alternative. Diagnosing diseases sooner is a key concern of many clinical laboratories, as is the determination of the appropriate level of antimicrobial to prescribe. A prototype chip is available that uses two nanoliters of volume to determine whether any of several antimicrobials are effective against a microbe. 

Other tests include C-reactive protein (CRP) blood tests to show if an infection is present. This test is based upon the correlation of inflammation in the body. ⁹

Avian influenza is a major epidemiological concern. A new biosensor has been developed to determine whether this virus is present in blood samples in about three minutes. This method uses gold nanoparticles that allow the viral particles to be detected with a nanobiosensor. ⁹

qPCR methods have also been developed to detect pathogens.⁹ Other non-molecular assays, like immunoassays, have also been developed for the detection of pathogens.¹⁰

Antibiotic resistance / sensitivity

Professor Jϋrgen Popp, of the Leibniz-IPHT discusses the use of Raman spectroscopy to provide a rapid result (under two hours) to determine whether a bacterial strain is resistant or sensitive to an antibiotic. Furthermore, one can obtain information on the concentration of antibiotic needed to constrain bacterial growth.¹¹ 

Molecular assays have been developed for quick detection of antibiotic resistance. Chromogenic agars can be an inexpensive option in place of molecular assays.¹⁰  

Biography

Jeanne Moldenhauer, Vice-President of Excellent Pharma Consulting, has more than 30 years’ experience in the pharmaceutical industry. She chaired the Environmental Monitoring / Microbiology Interest Group of Parenteral Drug Association for more than 15 years, served on the Scientific Advisory Board of PDA for 20 years, founded the Rapid Microbiology User’s Group, and is a member of American Society for Quality, and Regulatory Affairs Professionals Society. She is the author of many books and numerous publications, including book chapters and magazine articles.

 References

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8. Anonymous (2018) Enzymes for Culture Media. Downloaded from: http://www.emdmillipore.com/US/en/products/industrial-microbiology/culture-media/culture-media-for-pharmaceutical-and-cosmetics-industry/ready-to-use-media/enzymes-for-culture-media/jLqb.qB._P8AAAFAC_1kiQpx,nav on March 22, 2018.
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