Over 10 years ago a leading medical device manufacturer began using Cerilliant Certified Spiking Solutions^® in the preparation of reagents used in core drug test systems as a way to improve operational and material efficiency and to achieve batch to batch consistency. Cerilliant continues to provide this customer with a variety of these Certified Spiking Solutions^® which have been customized for concentration and fill volume. Cerilliant manufactures and stocks inventory based on customer projections and ships just-in-time as directed.

More recently, this manufacturer had become frustrated by inconsistent supply of key reagent components outsourced to other vendors. Consistency and accuracy of materials used in diagnostic test systems is highly critical to system performance and to patient care. Cerilliant was called upon to synthesize several key reagent components including some tied to core platforms and several which were in the development stage and many of which had no literature precedence. In addition, the customer did not have detailed analytical specifications – knowing only that the materials must work in their analyzers. After the first successful batch, additional batches were prepared for validation in the customer’s manufacturing process. Cerilliant worked with this customer to determine and agree critical specifications for future lots of each compound.

Cerilliant was chosen because of our devotion to quality, consistency, robust documentation, and regulatory compliance; our expertise in organic synthesis; our ability and willingness to scale up from development batches to production batches and to grow with the success of the test system; and our relationship approach.