Developing Rapid Microbiological Methods

Cynthia Martino of Bionique interviewed by American Pharmaceutical Review

American Pharmaceutical Review Interview with Cynthia Martino

Director, Research & Development of Bionique® Testing Laboratories

1. Mycoplasma testing of cell cultures is essential to ensuring the safety and efficacy of products. Can you briefly outline current testing methods and the trend toward RMM’s?

Traditional mycoplasma detection methods involve direct culture and indicator cell culture techniques. Combined, these two methods represent what has been termed the “gold standard” in mycoplasma testing. However, given the considerable time it takes to generate a result by these standard means, many organizations including Bionique are encouraged by the developments being made with alternative and rapid methods for mycoplasma detection.

2. With the rise of Rapid Microbiological Methods (RMM) for mycoplasma detection, where does the industry currently stand in terms of adopting these alternative methods?

Rapid microbial methods for mycoplasma detection represent a new way of thinking and have created a rather steep learning curve for industry, contract testing laboratories and regulatory agencies alike. However, we are now functioning at a level of understanding that has allowed us to move beyond the initial issues such as interpreting genomic copies vs. colony forming units.

Rapid mycoplasma detection promises to facilitate regular screening that could potentially save millions of dollars by preventing contaminated material from entering downstream processes and, most importantly, enhance consumer safety. In fact, given the emergence of novel cell based therapeutic products that require testing within incredibly short timeframes, this path to safer and more readily available products is absolutely necessary. Many organizations are pursuing PCR as an alternative method for mycoplasma testing and, based on recent conversations with clients and regulatory authorities, I understand there are a number of filings currently under review with the FDA that incorporate this method.

3. What are some of the lessons learned that should be considered during the validation of a RMM for mycoplasma detection?

In the early stages, PCR was initially thought to promise a quick and cheap way to detect mycoplasma. It is a very sensitive and accurate method but, as with any valid assay, it must incorporate adequate control measures in order to qualify the intended use, accommodate for specific manufacturing processes, and evaluate for inhibitory matrix effects. Any mycoplasma PCR that does not offer the assurances that these types of controls provide may be analytically questionable. Bionique is actively engaged in the development of a PCR system that addresses these and other emerging issues.

4. How is Bionique involved in further developing resources for mycoplasma testing?

We’ve made some critical developments including the introduction of a well-characterized line of reference standards to support our efforts and those of our clients in the evaluation, development, and validation of nucleic acid-based mycoplasma testing methods. This was a considerable gap in the development process that we recognized and were able to customize in order to meet evolving regulatory and industry demands. We actively participate in collaborative studies and are constantly engaged with the US and global mycoplasma testing community including regulatory authorities, manufacturers, and our clients in order to address challenges and share successes as we continue to develop a mycoplasma PCR platform. We recently discussed the elements of an effective testing strategy in a book chapter entitled “Identifying Mycoplasma Contamination: Concepts and Tools” published in the PDA text Microbial Identification: Keys to a Successful Program. Look for us at many industry conferences including the upcoming 2013 PDA Pharmaceutical Microbiology conference. We are certainly excited to be at the forefront of this field with so many important developments on the horizon.


This article was printed in the May/June 2013 issue of American Pharmaceutical Review, Volume 16, Issue 4.
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