18. März 2021 Testing power

Novel coronaviruses are old acquaintances for the team at altona Diagnostics GmbH. In 2003, the predecessor company artus Diagnostics became famous for developing the world’s first commercial real-time PCR test for the SARS virus in record time. As MERS emerged in 2013, altona Diagnostics also had a validated test kit up and running in no time. However, there is no doubt that SARS-CoV-2 and the scale of the coronavirus pandemic stretched the limits of imagination. “The world of virology is small, and we are very well connected,” says Stephan Ölschläger, who is responsible for marketing at altona Diagnostics. “For this reason, in a way, we were well prepared to start the rapid development of a product for the detection of the novel coronavirus,” says Ölschläger.

To ensure that the RT-PCR test for SARS-CoV-2 provided reliable results, it was validated in several national and international reference laboratories. By February 2020, the kit was on the market. With the high volume of testing, demand for the kits exploded. This was a major challenge for the Hamburg-based company, which currently has over 300 employees. “We optimized our production processes and increased capacity,” says Ölschläger. Among other things, the kit sizes were adapted, and the number of reactions per kit was increased to 384 and 4800 instead of the previous 96. “Processes have also become much more efficient in shipping and logistics,” says Ölschläger.

Bottlenecks in the supply of critical raw materials for laboratory reagents have so far been avoided. “We produce many of the essential components used in our PCR kits ourselves.” However, he says, a bottleneck in the supply of plastic materials, known as consumables, is becoming increasingly apparent. At present, altona Diagnostics is pushing ahead with several new in-house developments. “Because of the continuing high volume of tests worldwide, we are concentrating on increasing the availability of our fully automated AltoStar pipetting system,” says Ölschläger. In addition, the company is developing a combination RT-PCR test kit for the detection of SARS-CoV-2 and influenza which delivers results after just one hour - almost halving the reaction time.

High demand for synthetic RNA

With the breakthrough in the first approved COVID-19 vaccines from BioNTech/Pfizer and Moderna, everyone is talking about the biomolecules used in the business activities of the Hamburg-based contract manufacturer _> AmpTec GmbH: Synthetic ribonucleic acids (RNAs). “The efficacy data from the mRNA vaccine studies are fantastic, this is a real breakthrough for mRNA technology in medicine,” says Peter Scheinert, AmpTec’s managing director and founder.

“Our main product series, synthetic mRNAs for therapeutic applications, is benefitting from this huge global interest in mRNAs,” Scheinert says. Demand for mRNAs, whose main applications are not only in the area of mRNA-based vaccine production, but also in cancer therapy and gene therapy via genome editing, has increased significantly, he says. “Demand has also risen sharply for AmpTec’s other product category, molecular diagnostics,” says Scheinert. “We produce the viral reference RNA material for COVID-19 pathogen diagnostics, which runs as a positive control in every test,” continues Scheinert. The purity and homogeneity of the controls is particularly important for reliable test results. Due to high demand, AmpTec has now increased its number of employees to 46 and plans to grow further in 2021. In early January, AmpTec was acquired by German pharma and life sciences group Merck KGaA.

Test system based on electrical biochips

The team at Schleswig-Holstein-based Campton Diagnostics GmbH has taken a different approach to corona diagnostics. The spin-off from the Fraunhofer Institute for Silicon Technology ISIT in Itzehoe , which was founded in 2016, relies on a test system based on electrical biochips. This method detects biomarkers for infections, cancer, autoimmune or other diseases from a few microliters of whole blood within a couple of minutes. “Our system is portable, easy to use and can detect in 13 minutes whether a person has developed antibodies to coronavirus, for example,” says Eric Nebling, Managing Director and Chief Scientific Officer at Campton Diagnostics. “This makes it possible to quickly check a person’s immune status, for example, after a vaccination or an illness.” The central product, the blood analyzer named Campton Reader 100, is expected to be approved for use in research and development in 2021 and will then be used in serological diagnostics in research or clinical laboratories. The system is fully automated like a small single-use laboratory in a cartridge. In addition, the Itzehoe-based team is developing both a protein and a DNA test for SARS-CoV-2, which can be performed almost simultaneously on a reader. “This detection system is particularly suitable for random point-of-care testing.”