Manufacturing lateral flow assays using Creonate
Lateral flow assays (LFAs) provide low-cost, rapid and portable diagnostic tools for several therapy areas, from respiratory diseases like COVID-19 and flu to pregnancy, gastric-related diseases and cancers. Manufacturing LFAs not only needs specialist equipment but a highly regulated environment to ensure that every production step is controlled, meets specifications and ensures final product reproducibility. Creonate is a British contract manufacturer of lateral flow assays for medical applications. We work together with our clients to produce highly sensitive and specific lateral flow assays.
Creonate’s state-of-the-art facilities offer rapid and flexible contract manufacturing solutions
Creonate’s state-of-the-art 22,000 sq ft manufacturing facilities are spread across three floors. These separate units allow us to manufacture multiple products simultaneously. Our building management systems monitor temperature and humidity, and in-built cameras are used to inspect specific processes. Our facilities provide the ideal environment to manufacture and assemble your LFA device.
Our flexible manufacturing system allows clients to customerise processes to produce solutions that fit their specific needs. The assembly line is capable of small and high-throughput production, using both manual and automated production. We ensure the delivery of high-quality products by rigorously checking each manufacturing step. We are committed to continuous process improvements and monitoring production efficiency to ensure diagnostic devices are affordable.
Creonate has established experience in producing LFAs certified under medical device and quality system standards
Prior to establishing Creonate, we offered our custom-manufacturing services on behalf of Global Access Diagnostics (GADx). As part of GADx, we have developed in vitro diagnostic (IVD) and Research Use Only (RUO) lateral flow and immunoassays employing nanoparticles and latex beads for academic and commercial organisations. We have already manufactured LFAs in various formats for applications in infectious diseases, Peptests for acid reflux, diagnostics tests for cancer, as well as environmental testing.
Creonate works to ISO 13485 medical device and ISO 9001:2015 quality management system standards. We are able to rapidly employ or develop Standard Operating Procedures and Quality Control procedures.
Creonate’s fully trained staff have specialised knowledge and expertise in manufacturing, from the development of technical component production through to the finished LFA device.
Creonate has an extensive network of suppliers
Creonate’s established infrastructure is optimised for rapid product delivery. We have an extensive network of suppliers and component manufacturers, which results in a quick turnaround time for manufacturing LFAs. In addition, we work with our preferred local suppliers to offer sustainable plastic solutions that incorporate soluble plastics.
Our large warehouse facility can accommodate 360 Euro pallets and is available for short and long-term storage. We also offer a kitting and packing service, which includes boxing, palletising and wrapping products. As part of this service, we inspect and test packaging components to ensure they meet quality standards. Conveniently located, our secure facilities have excellent HGV access for quick dispatch following manufacturing. Contact us to learn more about how we can help you develop and manufacture your lateral flow assays.
