The importance of rapid methods, particularly those designed to support microbiological practices, was made by Andrew Hopkins who is an Expert Good Manufacturing Practices inspector with the UK’s regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA).
The value of adopting new technologies was made at the annual conference of the Pharmaceutical Microbiology Interest Group (Pharmig), which is a global society specializing in microbiological control of pharmaceutical and healthcare products. The meeting took place at the end of November 20717.
What are rapid methods?
Rapid microbiological methods is a broad term, covering methods that are both faster (either in set-up time or in relation to time-to-result) and more accurate (or sensitive) compared with traditional methods. The traditional methods are those described in pharmacopoeias, of which the United States Pharmacopeia and European Pharmacopeia are the global leads.
Some of the methods described in these texts are approaching one hundred years old and are premised by ways of thinking that only microorganisms that can be grown on standard culture media are a concern. The reality is very different, with an estimated 90 percent of microorganisms in the environment not growing on standard culture media (either because the media does not provide the necessary growth factors or because the organisms have undergone a physiological stress response).
In is conference address, Hopkins described how rapid methods have been around for thirty years and yet the pharmaceutical sector has made little progress in adopting them. While there are several technological and developmental reasons for this, the industry remains too conservative. It is the task of regulators, Hopkins said, to encourage pharmaceutical and healthcare facilities to adopt the best available technologies.
There are several reasons for this, the regulator explained. Results are delivered faster, which allows those tasked with contamination control (and hence medicinal safety) to make decisions faster; and results are more accurate, providing a more meaningful picture of the product and manufacturing environment risks.
There are also advantages for drug manufacturers. Culture based microbiological tests take several days for a result to be obtained (up to fourteen days for a test for product sterility, for instance). These lead times can be reduced significantly through rapid methods.
Examples of rapid microbiological methods include growth-based; biochemical and carbohydrate utilization for microbial identification; viable Staining and Imaging LED Raman Spectroscopy for cell counting; and respirometry, pressure sensing for detecting microbial presence.
Personalized medicines initiative
A further factor that should be pushing the demand for rapid methods, according Hopkins, is the expansion of personalized medicines. A driver in healthcare is towards smaller batches of medicines being produced for one patient. Here there will only be a limited number of available samples. In addition these products only have short shelf-lives and may, based on patient risk, need to be used before traditional text results are available.
Based on these reasons, and the advantages for pharmaceutical manufacturers in reducing inventory costs, the slow pace of rapid methods adoption needs to accelerate.