3D printing may potentially have an impact on the way that pharmaceuticals and vaccines are produced, including those for fighting the SARS-CoV-2 virus that causes COVID-19. The E.U.’s NESSIE project is a transnational European initiative that brings together five partners across Austria, Norway, and Portugal to develop a new generation of monolithic columns for separating molecules for biopharmaceutical production. The end result may be a quicker, more efficient and less expensive method for making vaccines. To learn more, we spoke to Martin Schwentenwein, head of materials for ceramics 3D printer manufacturer Lithoz.
The project is dedicated to improving the process of chromatography used to separate and purify molecules for pharmaceutical purification. During chromatographic operations molecules and proteins are separated based on size or selective interactions, such as how well they dissolve in water or fats. This is accomplished by pumping a pressurized liquid solvent with the material being purified through a column filled with a specialized material, which separates impurities or unwanted byproducts. The members of the NESSIE project are working to improve this column component to make the process more efficient.
The group is developing methods for tailor-making these columns to optimize the behavior of the fluid running through them and reduce changes in pressure that occur during the purification process. In particular, the fluid pressure drops as the material interacts with the column, limiting the speed of purification. By reducing this drop in pressure, the entire process can be made more efficient, thus improving speed and reducing cost.
Lithoz was brought into the project due to the fact that existing columns are made using silicon dioxide material. As a specialist in ceramic 3D printing, the company is able to offer its expertise to producing columns with the fine resolution and materials needed for biopharmaceutical purification. Silicon dioxide has the advantage of combining the porosity needed to filter molecules, while maintaining temperature stability. It can also be sterilized, which is often required for processing biopharmaceutical materials.
Depending on the pharmaceutical material that is being researched or manufactured, the purification operation can be made up to 20 percent more efficient. With the processing of easier molecules sped up by up to five minutes per run, this translates into hours or days of work saved in drug R&D or even days or weeks saved in mass production of medications and vaccines. At the moment, the partners have developed a proof-of-concept for improving column designs more generally, but Schwentenwein said that the columns can in principle be tailored for each specific biopharmaceutical product that is studied or produced:
“Of course, improving the speed is the most tangible outcome, but going beyond that, is the vision that the separation mechanics can be improved overall, and you can ideally move significantly beyond this 20 percent times saving. You can move more into the domain where it can really get to half the time that you need. But for that also the whole design has to be optimized, has to be tailored. For now, we’re aiming for this basic proof-of-concept that, by using this 3D printing technique in combination with ceramics, that you can get this improvement for the whole separation process.”
Schwentenwein said that these columns could be used for the purification of basically any molecule, whether it’s during the drug screening and research phase, or for production. This includes the wide array of vaccines and medications being developed to combat the SARS-CoV-2 virus.
Currently, there are about 23 companies creating such solutions. This includes more inexpensive drugs for treatment, such as the decades-old antimalarials from the chloroquine family of medications to more potentially costly medicines like remdesivir. As for vaccines, products range from more traditional vaccines derived from the inactivated virus to much newer DNA and RNA vaccines, classes of vaccines that were previously not considered acceptable for human use due to the fact that in some cases they could not provide immunity, may have unpredictable effects and could potentially cause unintended consequences.
Despite the uncertainty about these newer vaccines, several RNA and DNA vaccines, some developed by partners of the U.S. Department of Defense, are undergoing clinical trials. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in March that a vaccine won’t be available for the public for another 12 to 18 months.
Regardless of the timeline for the public availability of a SARS-CoV-2 vaccine, the technology developed from Project NESSIE wouldn’t necessarily aid in production immediately. However, it could be used to purify a vaccine or drug used to prevent or treat the COVID-19 illness.
At the moment, the team is fine-tuning its production process and ensuring repeatability for printed columns, determining that they are able to achieve feature resolutions of well beyond 100 microns very homogeneously throughout across entire batches parts. This is something that has not been available before. The project is set to conclude at the end of October this year, but it won’t likely be ready for commercialization quite yet at that time.
The group is looking for a manufacturer who is ready to manufacture columns in mass, which would require a farm of Lithoz ceramic 3D printers. According to Schwentenwein, using a single printer that has not been optimized for production, it would be possible to produce 50 columns daily. If this were scaled up, it would be possible to manufacture in the numbers necessary for the market.
The columns currently being developed are smaller, meaning that they are more suitable for R&D purposes, but the size can be made larger for biopharmaceutical manufacturing, which would mean fewer columns per print job. The biggest bottleneck at the moment, Schwentenwein says, is the lack of having a user/partner who is able to produce these columns in a quality controlled environment. However, he believes that they have the technology in place so that, once they find this partner interested in mass production, all that would be necessary would be to “pull the trigger.”
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