IVD Test Kits Case Study
The OEM Project Situation
A manufacturer of IVD lateral flow tests needed to quickly develop a new product to diagnose an infectious disease that had suddenly spread to several regions of the world, causing serious public health risks. The manufacturer's R&D group was tasked with creating a robust assay in the fastest way possible. Knowing that product performance and accuracy are extremely dependent on the raw materials used, choosing a raw material supplier that could provide the right level of quality, consistency and support in order to accelerate time to market was critical to the manufacturer.
MilliporeSigma's Operational Support
MilliporeSigma provided extensive technical support to the manufacturer's R&D team and consulted on production scale-up, quality control specifications and regulatory concerns. With decades of experience in lateral flow technology, antibodies and other critical components of lateral flow assays, the manufacturer was able to leverage MilliporeSigma's internal resources to seamlessly develop a product in a shortened period of time.
The Customized Solution
MilliporeSigma's dedicated support team of Application Scientists and Quality Engineers understood the manufacturer's unique challenge and provided solutions that enhanced the final design of the new diagnostic test kit. Having been very satisfied with the performance of MilliporeSigma's Hi-Flow™ Plus membranes from previously developed products, the manufacturer selected these high-quality membranes in addition to specific antibodies within MilliporeSigma's broad portfolio to develop a suitable assay in record time.
For this project, MilliporeSigma employed its ISO-compliant global facilities and network of supply chain partners to provide the manufacturer with a wide range of fit-for-use raw materials and unparalleled supply chain security in order to ensure every need was met for the desired kit.
Following the successful collaboration with MilliporeSigma, the diagnostic manufacturer was the first to market with this one of a kind diagnostic test kit, surpassing their competition, but more importantly, making a great stride to limit the spread of the infectious disease. This collaboration solidified a loyal relationship and led to discussions about designing future kits utilizing MilliporeSigma's OEM capabilities and expertise. MilliporeSigma is proud of this partnership and others of its kind, and is ready to help with other infectious disease challenges that require custom diagnostic kit solutions, which ultimately make a lasting impact on global human health.
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