“With a complete portfolio of Quality Control solutions, bioMérieux ensures the safety of patients undergoing cell and gene therapies.”
How is bioMérieux partnering with cell and gene therapy manufacturers to ensure the maximum benefits for patients?
These products have the potential to completely transform the treatment of many diseases. In this segment specifically, there are several areas where enhanced quality control can bring value.
The first goal is to help the manufacturers provide patients with cell and gene therapies that are safe, as with all therapies. We work to minimize the particular risks associated with cell and gene therapy, such as contamination. By ensuring the safety of these therapies, we can help protect patients from harm.
The second goal is related to efficacy, which must be clearly demonstrated. This means rigorously evaluating the efficacy of each therapy with well-designed clinical trials to ensure and provide real benefit to patients.
Our third goal regards accessibility. Today, cell and gene therapies are quite complex to develop and very expensive, which can limit their accessibility to patients who critically need them. Ensuring that these therapies are affordable and widely available is crucial to giving patients access to the most efficient treatments as quickly as possible.
Our last goal involves regulatory oversight. Because cell and gene therapy is such a rapidly evolving field, there needs to be strong regulatory oversight to ensure that therapies are developed and used in a responsible and ethical manner. This includes very rigorous clinical trials to test for the safety and efficacy of products, and marketing them in a clear, transparent way in terms of the outcomes of clinical trials.
The quality of bioMérieux’s analytical methods, as well as our close partnerships, help our clients meet all the quality standards that are needed to release their products. At the end of the day, our Quality Control solutions are making our clients’ lives easier.
Could you describe some challenges that the production of cell and gene therapies involve?
These therapies have been recognized from a scientific standpoint for a number of life-threatening conditions. However, the availability varies from country to country because of regulatory approvals. Also, because we are mainly talking about autologous products, samples must first be taken from patients. They are then shipped to manufacturing sites, where the cells are selected, engineered, and formulated before being shipped back to the hospitals where the patient is managed.
So, the supply chain for these kinds of treatments is pretty complex. Time is so precious when we’re delivering these therapies. We can’t accept that it takes several weeks — it all needs to happen in just a few days. Consequently, it is essential that we have a reliable network of manufacturing sites and hospitals that can take full advantage of these therapies. These therapies are not available everywhere, unfortunately.
What are the factors that allow bioMérieux’s customers to achieve the absolute highest levels of quality control?
bioMérieux places massive importance on quality control at every step of development. In the case of autologous approaches, these products need to be delivered quickly. To achieve this speed, we need specific, fit-for-purpose analytical methods for quality control. Furthermore, by reducing the time needed for quality control with automation and innovation, we can also reduce at least some of the costs related to these kinds of therapy. Our role now is to ensure our analytical methods are recognized by the regulatory authorities, so they can lead to safer, more effective, and more affordable therapies that pharmaceutical industries can develop worldwide.
In fact, for bioMérieux, there are three main pillars that guide our work in quality control for cell and gene therapy:
- The first is related to safety control testing, in which we develop and propose products for sterility testing, mycoplasma, and endotoxins. We thus ensure that no microorganisms, toxic substances, or anything bacteria-derived can be inside the product. As we develop innovative solutions to detect pathogenic organisms, we also strive to make them more affordable, more sustainable, faster, and easier to use. All of these things matter equally and fundamentally.
- Our second pillar of quality control is at the cellular quality level. By partnering with the company Accelix™, we are working to provide tools that can control the cells themselves, to ensure their viability, identity, and purity.
- Our last pillar is the environment in which these products are manufactured. To avoid contamination, bioMérieux proposes the 3P® ENTERPRISE solution, which offers full compliance and data integrity throughout the entire environmental monitoring workflow.
I should also mention our BACT/ALERT® platform. This automated, growth-based microbial detection system is now chosen by a lot of manufacturers for their sterility testing.
To sum up, we really do provide a portfolio of products and solutions that few of our competitors can match. It's a very exciting time we are living in to be able to help treat life-threatening diseases.