This development comes at an important time; the industry is under huge pressure to deliver greater productivity against a back drop of spiralling costs in bringing new products to market. If the current trend continues there is growing concern that the industry model is not sustainable.
In the last decade, pharmaceutical companies have been successfully reducing their bottom line costs. Operating efficiency levels, however, remain poor compared to other leading industries, particularly in test laboratories. Product testing is viewed as a high cost, low value-add activity. Companies continue to use high-cost scientists to carry out the testing resulting in poor productivity levels and a high degree of human error. Outsourcing is a potential solution; however, it doesn’t alter the fact that testing remains an inefficient, manual activity.
The product extraction step is the major bottleneck in the current process. This is particularly true for controlled released products with complex matrixes designed to prevent rapid release of the drug. For example, PA knows of some controlled release products taking up to 10 to 12 hours to extract the drug from the formulation using conventional glassware methods such as stirring or shaking. Even with high powered and highly intrusive methods such as homogenisation, extraction remains a major bottleneck in the test process. This poor productivity in sample extraction has meant that many pharmaceutical companies are unable to realise the full benefits of the new generation of fast LC systems and the uptake of these highly productive systems has been slow.
To complicate matters, the Quality by Design (QbD) and Process Analytical Testing (PAT) initiatives launched by industry regulators have increased the test load during development in earlier clinical trials phases. At this stage, where risk is highest, it is adding to the already high costs of drug development.
In response, tried and tested methods based on liquid extraction have suffered from declining investment as the industry looks for rapid non-invasive testing based on spectroscopy. However, this is a long term approach with many barriers to overcome before these immature technologies are properly established for this purpose. In the mean time opportunities are being missed with the mature technologies that exist (e.g. fast LC) that have yet to be fully exploited.
Pharmaceutical development requires more agile automation to off-set growing demand for testing. Equally, it is clear from our work that a new approach also needs to be scaleable to provide a route to high volume testing in manufacturing QC and potentially for at-line testing.
So what does the industry need to solve these problems? The Holy Grail for product testing has always been to have better automated tools that release scientists for more value-adding work. There has been limited success with existing commercially available automated sample preparation systems for testing solid dose products. Of those who have adopted such systems, few have realised a step change improvement in productivity and quality of data. Part of the problem is that implementation of large scale robotic systems causes issues with funding. The systems cross into territory requiring high level approval which often takes time and conflicts with other high priority projects. What is really needed is easier implementation of systems that are low cost and simpler to use for ‘business as usual’, where the business case is clear and effectively writes itself.
To address this un-met need, PA has developed a unique solution for automation of testing of solid dose products that directly addresses the requirements for faster cycle times, at lower operating cost, with less variability. The solution addresses the biggest bottle neck of sample extraction, particularly for controlled release products. Our solution is built on a scientific understanding of drug dissolution, as opposed to the traditional brute force approach of automation. PA has built and successfully tested a proof of concept system for our novel technology, known as RTE (Rapid Tablet Extraction, patent pending).
The technique can quickly create a sample solution from solid product, at the correct concentration, ready for analysis. Our system does not need intrusive mechanical extraction and instead relies on flowing liquids in a similar manner to HPLC. The system has been tested by one pharmaceutical company and has met all performance expectations. Our approach is markedly different to existing systems eschewing large scale robotic automation that is unpopular with scientists. Instead, we believe that a compact scientific instrument that integrates seamlessly into the portfolio of well established test instruments, such as HPLC, is the way forward.
PA is pressing ahead with the commercialisation of the system and plans to have the early models available by end 2010.
To find out more about PA's RTE sample preparation system, please contact us now.
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