In collaboration with Origin, Henkel recently announced that it has leveraged its ability to carry out biocompatibility and mechanical testing at its facility in Concord, Calif., and provided a range of 3D-printable medical photopolymers designed for use on Origin’s material development systems. With the onset of the COVID-19 pandemic, the demand for medical supplies such as testing kits has outpaced supply. The primary protocol involves conducting a nasopharyngeal (NP) swab test, which collects viral material from inside a person’s nasal cavity. Globally, few companies manufacture the swabs commercially, and all are overwhelmed with demand.
The swabs are traditionally made from multiple materials and adjoined prior to sterilization and packaging. Working cooperatively with Origin, Henkel supplied knowledge and technology to help design a swab that could be 3D printed at scale.
“From inception, the vision behind Henkel’s Open Materials Platform was to enable collaboration all along additive manufacturing’s value chain,” said Ken Kisner, head of innovation for 3D Printing at Henkel. “Working together with Origin, we were able to develop a product which is [as] effective as its mass-produced counterparts. With the constraints commercial medical suppliers are facing, this presents a significant opportunity for the 3D printing industry to demonstrate its capabilities, beyond prototyping.”
Origin’s programmable photopolymerization (P3) technology reportedly enabled the company to test different materials, print parameters, and designs in parallel to find an optimal solution in just a few days. The final clinically validated swab utilizes an intricate lattice design to collect the virus sample. It balances patient comfort with the ability to collect a reliable and sufficient sample.
The development effort also leveraged Henkel’s Albert software platform, which accelerates the innovation of new products by determining the materials that are utilized. With its ability to access Loctite’s material and post-processing knowledge and data, Henkel reports that Albert allowed it to recommend the best-performing material for the NP swab application.
“Nasal swabs are actually very complex instruments,” said Nick Talken, chief technology officer of Albert Software at Henkel. “The head of the swab utilizes a detailed lattice structure that’s designed to maximize the amount of virus collected. The whole thing has to be flexible and strong, not to mention safe for medical use. With the help of Henkel’s Albert Software, we were able to quickly match the best Loctite material for this specific application.”
In leading the effort, Origin also collaborated with Beth Israel Deaconess Medical Center (BIDMC) on the swab’s development. BIDMC conducted an initial clinical evaluation for human factors and materials testing, and ensured that the final product would be compatible with the polymerase chain reaction (PCR) method that is used in laboratories to test for COVID-19.
“By working collaboratively and utilizing each other’s technologies, we identified, optimized and scaled the manufacturing process to bring an application to market extremely fast,” said Chris Prucha, founder and CEO of Origin.
Origin’s NP swab is classified as a sterile device and is considered a finished medical product. This means it must adhere to “current good manufacturing practices” (cGMPs), which are regulations enforced by the U.S. Food and Drug Administration (FDA) and documented in the Code of Federal Regulations (title 21, part 820). Both Henkel and Origin collaborated to conduct testing and validate each step in the sterilization process, which includes ethylene oxide (EtO) and autoclave sterilization. They also performed mechanical testing and packaging validation, which determined the product’s FDA-compliant shelf life.
The NP swabs are reportedly 100% traceable and contain a digital thread that can be traced back to the manufactured base chemistries, which were produced using Albert software. Origin’s sterile NP swabs are currently shipping to leading healthcare facilities, government institutions, and independent testing centers in the U.S. and several other countries.