24/7 mass production on NETSTAL ELION MED
Disposables for new Roche SARS-CoV-2 antibody test

Following their breakthrough in COVID 19 testing, Roche has now announced the development of a reliable SARS-CoV-2 antibody test. The test will enable the identification of people previously infected with the new coronavirus who are therefore presumably immune to the virus. In the coming months, vast amounts of disposable pipette tips and cups for carryover-free pipetting will be required. A perfect task for the high-performance NETSTAL ELION MED from KraussMaffei.

Text Michael Birchler  Photos KraussMaffei

Within a brief period of time, the SARS-CoV-2 virus has radically changed the lives of billions of people. The core component for overcoming the pandemic is effective diagnostics. Because in most cases the symptoms of COVID-19 are very similar to that of a normal flu or cold, the testing of currently infected people via PCR diagnostics remains a major priority. 

Without antibody tests no reliable data basis

The next important step is the broad-based search for antibodies. Swiss pharmaceutical group Roche is again the driving force in this area. A few days ago, the global market leader in diagnostics consequently announced it had developed a serological antibody test. The test will establish whether a person has been previously infected with the new coronavirus and whether their immune system has formed antibodies. Although not definitively proven, scientists assume that after recovering, infected people are immune to the SARS-CoV-2 virus for a certain period at least. The detection of antibodies is epidemiologically crucial because it enables the so-called level of endemic infection within the population to be determined. This allows the actual death rate to be calculated using a database that is as conceivably complete as possible. Public health measures implemented in the fight against the spread of the disease are also better and more purposefully coordinated.

Disposable items for antibody assays
Disposable items for antibody assays
Pipette tips and cups in racks are manufactured in the clean room on all-electric injection molding machines of the NETSTAL ELION series.

40,000 analytical systems worldwide in search of antibodies

Roche aims to have the serological Elecsys anti-SARS-CoV-2 test rolled out in all countries accepting the CE mark by early May. American regulation agency, the FDA, has applied for emergency approval. The procedure involves an in vitro test in which human serum and plasma from a blood sample is measured under luminescence to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. 

Two antibodies are sought during the analysis, the immunoglobulins M and G. M is formed shortly after infection. By contrast, G is only evident later, but is activated upon reinfection so that the body can successfully fight the virus. The antibody tests are carried out on Cobas e analyzers, which are widely used in laboratories and hospitals. Roche is said to have over 40,000 antibody analysis systems on the market across the globe. The fully-automatic machines deliver test results in around 18 minutes, with a throughput rate of up to 300 tests per hour, depending on the model.

With a doubling of the output, the system requires only 50% of the floor space compared to previous systems also operated with NETSTAL.

24/7 production of pipette tips and cups for test kits

Roche plans to ramp up test kit capacity at its Penzberg production facility in Germany to produce quantities in the high tens of millions per month by June. Production after that will be further increased as quickly as possible. Without injection molded plastic disposables the tests could not be carried out. Substantial volumes of disposable tips and cups will be needed to enable carryover-free pipetting. As a consequence, production capacity at supplier companies that specialize in these items will also need to increase. The NETSTAL ELION, one of the top performing injection molding machines for demanding diagnostic applications, is frequently the go-to machine in such cases. Many customers rely on NETSTAL to set up their systems. Applications operating today in cleanroom environments (ISO 8 GMP C) are run on high performance, medically equipped NETSTAL ELION series machines. Although involving disposable mass-produced items, maximum precision, perfect material homogeneity and optimum reliability are decisive in the manufacturing process. This all hinges on a number of factors: In continuous, year-long operation, the extremely robust machine design has to ensure reliable and mold-sensitive operation 24/7. At the same time, precise shot-to-shot consistency guarantees production within extremely tight tolerances and with minimal rejection. All this in cycle times of just a few seconds. 

Clean room compliant mold installation space
Clean room compliant mold installation space
The clamping unit of the NETSTAL ELION MED was consistently designed for use in clean rooms.
Clean Purge
Clean Purge
The patented nozzle hood reduces particle discharge during purging by automatically controlling the volumetric flow.

230 million units with two NETSTAL ELION machines in one production cell

A particularly powerful all-in-one system solution for manufacturing Elecsys cups with tips is currently in operation at three leading manufacturers. Each system comprises three all-electric NETSTAL injection molding machines. The pipette tips are produced in 64 cavities on a NETSTAL ELION 1200-530, while the cups are made on a NETSTAL ELION 1750-530 equipped with a 64-cavity full hot runner mold. These two machines feed the centrally arranged handling solution encompassing total in-line camera quality control, fully automatic cup and pipette placement and transport-ready packaging of the finished products. 

The required racks are manufactured in a stack mold on an adjacent NETSTAL ELION with a clamping force of 2,200 kN and are fed into the system prior to placement. A high-performance system such as this has an annual output of up to 230 million units. The key feature: With a doubling of the output, the system requires only 50% of the floor space compared to previous systems also operated with NETSTAL. Against the backdrop of costs per cleanroom square meter, this provides a substantial competitive edge, which is only amplified in this coronavirus era. When demand suddenly increases, NETSTAL users can benefit enormously from the higher productivity per unit of area.

Up to 230 million units per year

System solution with three NETSTAL ELION injection moulding machines for the production of disposable pipette tips and cups in racks

Highest purity and cleanliness for reliable test results

Roche is the first large concern to develop a Sars-CoV-2 antibody test. Dozens of small and medium-sized companies in Asia, Europe and the USA are already on the market. The array of test kits range from those that have to be used in laboratories right through to self-tests that people can do at home. A major problem so far is the high error count of these tests. This has consequently led to millions of tests from an Asian manufacturer having to be destroyed because only 30 percent of the results were correct. Users may be lulled into a perilous false sense of security if they receive a positive result despite never having been infected with the coronavirus. Contrastingly, operation of the Roche Elecsys anti-Sars-CoV-2 test is fully automatic and is also extremely easy to use. After initiating the analysis in the lab, manual intervention is no longer required. The risk of contamination or user error is therefore extremely small, which according to Roche makes the test very reliable. Not least, also due to the fact that the disposables produced on NETSTAL ELION machines are of the highest standard in terms of purity and cleanliness.