The In-vitro Testing Laboratory has had a busy start to 2017. Most recently, we presented at the Society of Toxicology (SOT) conference on the improvements of the multiple hemocompatibility tests, including the In-vitro Blood Loop Assay and Platelet/Leukocyte Count Assay. Collaboration with the FDA is ongoing for the In-vitro Blood Loop assay – we have submitted our methods and protocol to the FDA who is actively reviewing and providing feedback. We are hopeful that this will conclude within the next couple of months, with the intention to have a readily accepted assay to replace or reduce the number of In-vivo Thrombogenicity studies. Additionally, the ASTM Platelet/Leukocyte assay was recently modified by our Technical Scientist by altering the anticoagulant from sodium citrate to a low concentration of heparin (~1 unit/mL), which has increased the sensitivity of the assay and positive results have been consistently observed. These two tests provide our clients with meaningful assessment of thrombogenicity in both dynamic and static models and, in contrast to the current paradigm of testing, offer predictive outcomes to help our clients in screening of materials and/or gaining FDA acceptance of a finished product. The progress made in these two assays has been solid and we continue to investigate improving industry standards for hemocompatibility testing, including evolving the Complement Activation Assay. Recent efforts are pointing to an integrated system where multiple hemocompatibility endpoints can be leveraged from less client material! Our R&D in biocompatibility testing does not stop at Hemocompatibility. We strive to research, improve and perfect assays in as many modalities of testing as possible.
While the IVT lab remains busy with routine biocompatibility assays, we are constantly looking towards the future. The lab is actively pursuing validation of the In-Vitro Skin Irritation Assay, the In-Vitro Skin Sensitization assay, and the In-Vitro Pyrogenicity Assay. The plan is to complete validation by the 3rd quarter this year. While the industry may not be ready to replace the In-vivo assays, we will continue to present a compelling argument for change and we will be ready when that change takes hold.
Finally, the IVT team at APS is here to help you with any test requests or customs studies. Even with all of the forward looking research that is ongoing, our experienced team will always be conducting standard assays for your development or submission needs – with over 20 years of experience in the biocompatibility industry, we assist clients every day with questions, concerns or issues related to testing and results. Our goal is to provide you with whatever testing services or regulatory assistance you may require, no matter the size of the scale. From In-vitro services, analytical testing, regulatory services, to large animal interventional services, APS has the staff and the expertise to provide with best-in-class testing that can see your product throughout the product development cycle – from feasibility testing to FDA submission and through post-market surveillance regulatory services.