Lubricant Particulate Contamination Brought One
Biopharmaceutical Launch to a Screeching Halt
By Jackson Thornton, Ph.D. – Associate Director of Research
During their pre-clinical trial studies, one pharmaceutical company found protein/silicone oil aggregates in their prefilled syringe. The company already had a production line commissioned, built, and qualified at their contract manufacturer’s facility. This protein/silicone oil aggregate posed a significant risk for the product moving forward. With huge investments of money and time in the product development, the silicone-oil syringe lubrication stopped the entire launch in its tracks.
TriboFilm Research was brought in to see if TriboLink-Si® technology could solve the silicone oil contamination issue. Our team demonstrated that downstream plasma crosslinking of the silicone oil could reduce the particle burden by more than 85%. This technique required minimal changes to the production line and no changes to any of the syringe components which kept all of the quality systems intact. With minor changes, the project was back on track for clinical trials and product launch.
TriboFilm realized that replacing silicone oil with another liquid would not be the solution. Instead, our team wondered: what if we designed a lubricant that attaches to the surfaces of the prefilled device?
This research (partially funded by the National Institutes of Health through an innovation grant) culminated in a patented Downstream Atmospheric Plasma Technology that crosslinks and immobilizes a lubricant onto a pharmaceutical container.
Immobilizing the lubricant reduces the tendency of the lubricant to displace from the syringe barrel and into the drug product, which results in fewer sub-visible particles.