With an incubation period of at least 14 days, it’s no secret that the current compendial sterility tests are too long for a variety of industries and product types. The USP expert panel identifies four main stakeholders when discussing the need for a compendial rapid sterility test:
- Sterile compounding manufacturers
- Positron emission tomography (PET) drugs/short –lived radiopharmaceuticals
- Cellular therapeutics
- Traditional pharmaceutical manufacturers
Below are some important take away from the recent USP Modern Microbiological Methods Expert Panel publication.
The expert panel has identified 15 major User Requirements Specifications (URS) for a rapid sterility test system. Six of the most critical are listed below:
- The ability to detect a wide range of microorganisms (specificity)
- Limit of detection (LOD)
- Time to result
- Improved patient safety
- Sample preparation
- Sample quantity (i.e. compatibility with the compendial sampling requirements)
With the proposed URS in mind, the panel recommended 6 unique technologies to serve as proof of concept studies to develop a risk-based compendial rapid sterility test.
- Adenosine triphosphate (ATP) bioluminescence (offered at Gibraltar Laboratories)
- Flow cytometry
- Isothermal microcalorimetry
- Nucleic acid amplification
- Solid-phase cytometry
The formation of the USP expert panel to help develop a compendial rapid sterility testing chapter is not to help manufacturers increase their profit margins… The focus is to improve patient safety by allowing the quicker release of treatments and/or ability to implement corrective actions sooner. The development of a risk-based rapid sterility testing system will primarily serve to benefit manufacturers of short shelf life products such as the compounding, cell therapy and PET industries. However, it has been observed that some rapid instruments have shown to be more sensitive to even the compendial test. Similarly, the limitations of the compendial sterility test are well documented. For this reason, it is important to think not only of a rapid sterility test as a means to increase the time to result but also as a more sensitive, objective and reliable means of detecting a contaminated batch. As the field of microbiology continues to advance, so do the microbiological detection technologies. The addition of this committee is a step in the right direction for progressing the field of industrial microbiology.
As these technologies continue to advance, our customers can rest assured that Gibraltar will as well. As part of our mission to stay atop of these advancements to provide you with the best, most up to date microbiological testing service available.