1. Why is there a need for rapid testing, specifically in sterility and environmental monitoring?
Some of this may be common knowledge to your readers, but it is worth reiterating. There is a need for rapid microbiological testing in pharmaceutical manufacturing. Businesses continue to test using methods that were developed more than a century ago. You can understand why the method is so prevalent. It works, and it is a low cost. But, there are drawbacks, one of which is time.
In a typical manufacturing flow, multiple steps require some kind of microbial testing that can take anywhere from 5-7 days for water and bioburden and 3-7 days for environmental monitoring. Add to that a 14- day sterility test and product is either waiting for release, or being released at risk.
We hear more and more feedback that companies want to accelerate the micro test, especially in light of the faster testing in other areas of QC, and the risk of shipping contaminated products.
2. Why is this issue so critical right now?
Pressure has continued to increase on pharmaceutical manufacturers to deliver high-quality products in a timely manner. With drug shortages on the rise, it is imperative for manufacturers to operate as efficiently as possible. In addition, quality control departments are overwhelmed and understaffed. Automating repetitive tasks such as plate colony counting and removing manual data entry can alleviate this pressure. Finally, reduction of the time it takes to get results from sterility and environmental monitoring tests can have a direct impact on a drug’s time to market.
3. What are the roadblocks to adopting rapid testing technologies?
This is a question we, and many others in the space, have been asking.
4. Why the delay in the adoption of rapid method?
We have looked at several pieces of research and our own anecdotal feedback from prospects and we have learned a few things, much of which has to do with the technologies currently available in the market.
- Most rapid methods lack breadth of applications. This means that a QC lab has to use multiple technologies and different instruments to conduct their routine testing.
- Some rapid methods are rapid, but come at the cost of introducing complicated, multi-step processes to prepare and analyze the sample. This added handling increases the potential for outside contamination.
- Some methods are destructive, which creates issues since in many instances the sample must be retained for identification.
- Some have low sensitivity, leading to the risk of false positives. Customers have told us that if a rapid method could overcome these issues, that method would be able to overcome the roadblocks.
5. What specific products or services is Rapid Micro Biosystems delivering to the market next year?
We are excited to announce the 2013 availability of two new products; the Growth DirectTM System for Environmental Monitoring and the Growth DirectTM System for Sterility. While the new systems deploy the existing, proven Growth DirectTM detection technology platform,they utilize a revised approach to the automation, providing a high sample throughput in a small footprint, and a touchscreen user interface. In addition, there are new consumables specific to each test.
6. How will these meet consumer needs and overcome challenges with implementation?
These products were developed based on feedback from pharmaceutical professionals working in QC microbiology. They told us that they wanted a technology platform with the following attributes:
- Sample preparation should match their current steps as closely as possible. Our systems support comparable sample preparation steps, making implementation and training simpler.
- The device should align to Lean principles – Many QC labs have Lean Initiatives, and are working to eliminate waste in their processes. Our new technologies automate everything after the sample is prepared and loaded, eliminating unnecessary steps and delivering results remotely and to the LIMS system.
- The test should not destroy the sample – In the event of a contamination, the lab needs to identify the type of contaminant. Many technologies destroy the sample while obtaining the result. Our technology is non-destructive, leaving the sample available for microbial Identification.
- The technology should make my job easier – Because our technology includes an automation component, microbiologists can work on higher priority activities while the Growth DirectTM does the incubation, analysis and reporting of samples, including alerts for out of specification samples.
- The technology should support the closed loop testing requirements of Sterility. Our cassettes are designed for operation in an isolator or clean room, the sample preparation is totally closed loop—so no external contamination is introduced during sample prep. We also support both the aerobic and anaerobic test environments.
- The technology should support the high volumes of environmental monitoring. The automation component of our technology includes two incubators that can process nearly 300 samples per day of a single temperature Environmental Monitoring test and over 200 samples per day if the test requires two temperatures.
- The technology should be rapid. Initial positive results are available within hours of starting the test. For a typical 5-day environmental monitoring test, the results are available within about 2.5 days; for the typical 14-day sterility test, the final results are available in 7 days.
7. When will these solutions become available for customers?
These technologies will be available in the first half of 2013. For parties that work in pharmaceutical manufacturing and would like to see the technology before its release, Rapid Micro Biosystems is hosting half-day, hands-on workshops. Visit the Rapid Micro Biosystems home page for more details: www.rapidmicrobio.com