In general, how have conventional and rapid microbiology methods evolved over the last 20 years?
Although conventional methods haven’t evolved tremendously over the years, we and others have made continuous improvements to these mainstays whose versatility and robustness is demonstrated by their longevity in the industry. One such improvement was our introduction of the first environmental monitoring plate with a lockable lid, LOCKSURE®; which helped reduce the number of technician errors by increasing sample security. Similarly, bioMérieux’s development of flexible-temperature storage EM media with longer shelf life has given our customers more options to not only improve performance in the lab, but also streamline quality control and supply chain operations. At launch, we had less data and experience proving their robustness and their superiority in enough settings. It took time to build evidence, to overcome some regulatory complexities and to define which were the best areas of implementation. Rapid methods, have a narrower scope of performance or usefulness than conventional. Our first platforms weren’t built for pharma originally, we had to adapt them and determine where we could add the best value and help our customers overcome the complexities and get the most out of these technologies. Some of our customers pioneered and built the vision with us. For example, in the US, three years ago, our continuous efforts to advocate for the ScanRDI® for high-value added products met the specific need of the compounding industry, looking for adequate ways to ensure the sterility of their production. We were looking for a specific configuration where they required instant results for high-value added drugs, with very short shelf life and produced in very small batches. It further helped to structure this market and improve its practices in microbial control. In the past years, the boom in bioproduction and cellular therapy is creating new needs in microbial contamination control for complex and extremely high-value added drug products and some totally disruptive therapies, not sterile by design, but with the need to be non-contaminated. The underlying science is being built now as we speak.
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Over this same time period what has been bioMérieux’s mission? How has the company helped the pharmaceutical industry bring safe and effective treatments to market over the last 20 years?
We have always been committed to the continuous improvement and evolution of conventional media be it environmental monitoring, sterility testing or media fill testing. We have invested in manufacturing facilities and in R&D to provide the best in class solution and push the limits of the performance of conventional media. bioMérieux has always believed strongly in the long term needs and adequacies of rapid methods. We have constantly developed and put in the market new solutions, aiming at improving time to result, traceability and data integrity, fitting the needs of crucial steps in the value chain transformation. bioMérieux’s greater mission is to pioneer diagnostics.
In the pharma Industry, we embody this vision in pioneering rapid methods and providing constantly improved solutions adapted to an industry in perpetual evolution itself.
As the manufacturing processes become more and more complex and requirements from the regulatory bodies are becoming more stringent, we have increased our interaction with our strategic accounts to develop innovation closer to their specific needs and where we could maximize the value of rapid methods in microbial contamination control. There’s not a single project now where we don’t involve our main partners to define and make products adapted to their context, whilst keeping in mind a bigger community.
Specifically, can you describe how the company’s conventional microbiology methods, rapid microbiology methods and data integrity tools help pharmaceutical companies meet their clean/ sterile manufacturing requirements?
Our greatest attribute is the breadth of our product portfolio. We started working with pharma companies with our existing clinical range based on culture media and ID platforms. We have enlarged our portfolio to fit each step of the microbial contamination control for all the pharma processes. Our media has been improved to fit the pharma needs and the specific regulation requirements. Our methods are designed for providing faster and rapid solutions for specific processes where time is a critical element in their transformation of raw materials into high value medical products. We have a view of the whole chain of transformation on drug products and ensure we provide to our customers a global solution with continuity.
In cell and gene therapy, we have our standard portfolio of environmental testing solutions and ID solutions and to test a new category of drug products. In addition, we are working with our customers to adapt our automated technology BacTalert® to the specific needs of rapid sterility assurance for non-sterile-non-contaminated therapies, which require rapid manufacturing and almost immediate re-implantation in the patients’ body.
Looking ahead, are there any microbiology technologies/services being developed now that will help pharma companies bring safe products to market? How will bioMérieux meet this challenge for its current and future clients?
We are currently developing a full range of recombinant factor C for endotoxin testing, bringing more robust and easy to operate solutions for pharma customers, notably adapted to the complexity of biologic products, medical devices, and cellular therapies. We are also investing in bringing more rapid and easier to use automated solutions for the testing of mycoplasma, an increasingly important parameter in the context of the development of cellular and gene therapies. We are bringing added data integrity features to our conventional range.
When providing rapid solutions we always offer a systematic level of service implementation with specialized assistance to help companies in the support of complex systems and regulatory requirements. We try as well to contribute to the scientific debate with the publication of studies and regular scientific communications on topics which matter to the community. We want to be active and leaders also in the scientific animation of the microbial contamination community. It’s part of belonging to our community, expressing our pioneering spirit and moving forward in the development of new methods.
The way we envision technology and scientific leadership comprehends collaboration and integration of the best concepts and methods through partnerships and mergers and acquisitions.
The advancements in science and technology are numerous and constant, we can’t be at the origin of all innovations. We are therefore constantly benchmarking ourselves to ensure we contribute to the development of the best solutions for our customers, regardless of where they were invented.