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Conducting cell research against ticking time bombs

Will we soon have better treatments for cancer and diabetes? To address this issue, Merck KGaA, Darmstadt, Germany has developed two products, SmartFlare and Clarisolve®.

WHAT IS THE FUTURE OF BIOPHARMACEUTICAL RESEARCH?

In order to understand nature, you have to measure it. To find out how fast children are growing, use a yardstick. If you are afraid of getting heatstroke, take a look at the thermometer. In neither of these cases does the measuring equipment influence the measurement result. 

Biopharmaceutical researchers would also like to have such methods to assist them in their quest for treatment strategies for widespread illnesses such as cancer and diabetes. Unfortunately, biological cells are so tiny that any attempt to measure them risks changing or even destroying them. Until recently, researchers were unable to analyze individual living cells repeatedly without killing them. As a result, it was impossible to obtain important scientific data. 

Outliers disappear in the statistical noise

An adult human being consists of more than 37 trillion (37,000,000,000,000) cells. In many cases, however, dangerous illnesses can be caused by a mutated gene in a single cell. 

Standard diagnostic methods cannot discover such cells at an early stage. This is because traditional diagnostic procedures analyze cell samples as a uniform mass. Since even tiny samples contain billions of cells, individual outliers become invisible in the average statistical values of such swarms.

Cells are as unique as human beings.

amish patel

Merck KGaA, Darmstadt, Germany

research center in Temecula, California (USA)

Biopharmaceutical researchers are therefore seeking new methods for defusing the time bombs in people’s bodies before they can do too much damage. This task is facilitated by the state-of-the-art analysis of individual cells. “In the same way that each person is unique, each individual cell, even cells from the same lung biopsy sample from a patient, for example, behaves differently,” says Amish Patel, a product manager within Life Science business of Merck KGaA, Darmstadt, Germany. “Individual cells within the same population of cells may differ dramatically, and these differences can have important consequences for the health and function of the entire population. For example, while many chemotherapies are effective against the majority of cells, there still remains a small subset of tumor cells, cancer stem cells, that are resistant to these treatments allowing the cancer to persist.”    

Biopharmaceutical research: Scanning the same cell over and over again

Merck KGaA, Darmstadt, Germany has reached a real milestone on the road toward making this vision a reality. The company’s research center in Temecula, California (USA) has developed a new product called SmartFlare — a reagent that enables researchers to detect and quantify specific biomarkers in individual living cells. Such measurements enable scientists to draw important conclusions regarding the current condition of a cell. 

Because the reagent leaves the cell again after the measurement is taken, the cell’s condition remains unchanged for future analyses. This makes it possible to systematically scan cells for various clinical pictures, thus increasing the likelihood that hidden dangers could be discovered early on.

The potential importance of SmartFlare for biopharmaceutical research was recently highlighted by the professional journal R&D Magazine, which presented the product with one of its annual R&D awards in 2014. With these awards, the renowned publication has been honoring the 100 most technologically advanced products of each year for the past 52 years. 

With its Clarisolve® depth filter, Merck KGaA, Darmstadt, Germany even had a second innovation among last year’s top 100. Whereas SmartFlare opens up new opportunities for cell analysis, Clarisolve® increases the effectiveness of cell production, thus boosting the economic efficiency of the process.     

Clarisolve® makes biotech more efficient

Fermentation capacity used to be a limiting factor in the production of biopharmaceutical molecules. This was the case in the production of monoclonal antibodies (mAbs), which account for a significant part of the total market value. However, the biopharmaceutical industry has managed to eliminate this bottleneck by developing high-performance hosts in the form of yeasts, bacteria, and mammalian cells. With the help of optimized nutrient media, these hosts generate much higher cell densities than in the past. The challenge now is to attain the same level of efficiency for the separation of the cells from the nutrient media.

Clarisolve® depth filters provide a completely new solution for this task. The filters were specifically designed for the feed flows of mammalian cell cultures that have a high cell density to enable mAb production. The size of the particles in these feed flows can vary. The filters have also been successfully used in microbial and vaccine applications. Unlike surface filters, which retain materials such as particles and gases on their surfaces, depth filters store the separated materials in their interiors.     

The Clarisolve® depth filter makes the production of biopharmaceutical products more efficient – for example, here at the company’s facilities in Cosier-sur-Vevey, Switzerland. The Clarisolve® depth filter makes the production of biopharmaceutical products more efficient – for example, here at the company’s facilities in Cosier-sur-Vevey, Switzerland.

The Clarisolve® depth filter makes the production of biopharmaceutical products more efficient – for example, here at the company’s facilities in Cosier-sur-Vevey, Switzerland.

“Clarisolve® enables users to separate the cells from the feed flow in a single process step,” says Jennifer DeKarski, a marketing manager within the Life Science business of Merck KGaA, Darmstadt, Germany. As a result, centrifuges are no longer needed. In addition, the filter’s design and composition reduces the effort needed to put them into operation. “On average, the volume yield from Clarisolve® is twice as high as that of conventional depth filters,” says DeKarski about the results from initial customer projects.

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