Seite 4: An era of mRNA drugs?

Inhaltsverzeichnis

However, mRNA is very sensitive. In cells, it usually only survives a few minutes. CureVac's printer modifies it to make it more stable and packages it in lipid beads. Purifying the desired mRNA is also essential, says Bergmann, otherwise impurities could harm the patient.

CureVac expects to receive the license to print the first mRNA therapeutics before the end of this year. The company would like to use them to supply university hospitals and large research institutions worldwide for clinical trials. In principle, however, the drug factory could also be located directly at the patient's bedside or taken to countries that are currently struggling with a new variant of a virus, says Bergmann. The factory functions universally and can supply more than just one type of mRNA. The control system for this is currently being developed by Tesla Automation, originally the German mechanical engineering company Grohmann Engineering, headquartered in Prüm. Elon Musk, or Tesla Motors, bought the specialist for microprocessors, memory chips, sensors and control units in 2017.

Trend toward individualization in medicine

Now just two vaccines against covid-19 are based on mRNA. Thousands of other drugs, on the other hand, are made from other substances. Nevertheless, Bergmann believes in an era of mRNA drugs and thus in his flexible mini-factory. The trend toward individualization in medicine gives him hope for change - especially in cancer medicine, where there is a sense of optimism. Patients are now treated differently after their cancer cells have been genetically and molecularly analyzed. CureVac wants to inject precisely that mRNA into the body that causes healthy body cells to form the cancer cell receptor and mobilize the body's defenses against it. Others have also been infected by the spirit of optimism: The U.S. start-up Nutcracker Therapeutics also wants to come up with an mRNA printer to advance into the field of cancer medicine.

"If mRNA therapeutics gain in importance, printing in small facilities is a highly interesting approach to making production more flexible," says Henrik Jeimke-Karge, press spokesman for the Association of Research-Based Pharmaceutical Companies. Others are more skeptical. Glatz adds: "When the genome was deciphered in the 1990s, it was said that we would soon have only gene therapeutics. But classical active ingredients will not lose their importance for many decades to come," he says.

In any case, the pharmaceutical industry would have to change fundamentally if it were to abandon hermetically sealed production halls in favor of bedside devices. Until now, every new active ingredient has required several clinical trials, and their design must meet strict criteria. From Asia to Europe, this regulatory practice has become established. However, Bergmann says, "In our case, only the device and the manufacturing process are then approved, not the drug itself."

Modular plants are in demand in Europe

Detached from the importance of mRNA therapeutics, the industry has caught a trend towards flexible and modular production. Modular plants in which different substances can be synthesized are now in demand in Europe, one hears from the plant manufacturers. On the one hand, they are a tribute to the increasing individualization in medicine - as taken to extremes with mRNA printers. On the other hand, they are a reflection of the increasing cost pressure in the pharmaceutical industry. Before an active ingredient becomes a drug, three extremely costly clinical phases have to be passed through, and the time in which the then approved drugs can be sold profitably under patent protection is short, at 20 years.

The pressure in the pharmaceutical industry to produce these drugs quickly in commercial sizes is great, because generic manufacturers are virtually in the starting blocks with the day of approval for active ingredients that promise broad use. However, planning and building a conventional greenfield plant can take up to three years - time that comes off the profitable 20 patent-protected years. Building modular plants can cut that time to less than two years, according to Exyte, an international plant engineering company based in Stuttgart, Germany. And even if the next pandemic comes, agility - the ability to react as quickly as possible with adapted formulations to new virus variants, for example - is more important than ever. In flexible production plants like the one in Freiburg, the modules for different products only need to be adapted and recombined.

Whether it's pills popping out of a machine next to a patient's bedside, factories running remotely without humans, or countries spending their money to rebuild basic health care, securing access to medicines may need one thing most of all: Diversity.

(jsc)