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Case Study

The Project Situation

A large, established diagnostic manufacturer was seeking the help of an external manufacturing partner for production of their IVD HPLC buffers for their diagnostic instrument. The client was seeking OEM support for two reasons: 1) the client had reached production capacity at their ISO 13485 site for a routine HPLC buffer used on their diagnostic instrument, truncating further product development and 2) the client's production site was situated in a geography prone to natural disasters so there was a strong need for back up production capabilities.

Our Operational Support

MilliporeSigma set up a dedicated team to evaluate the formulation of these buffers, cost out the project and prepared a proposal for production. The team evaluated the raw materials and helped the client validate alternate raw materials from our catalog where appropriate to increase supply chain strength and lower costs. The client was brought in to audit our Saint Louis ISO 13485 manufacturing site.

The Customized Solution

We developed a robust manufacturing procedure for the buffers, successfully assisted the client in validating our raw materials and delivered a cost effective final proposal.

Results

MilliporeSigma is now primed for back up production in case of emergencies and is progressing with the client towards taking over a portion of the routine production for these products.