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Biotech Case Study: Quality

The Client

A publicly traded company with a leadership position in diagnostics was experiencing difficulty with reference material from a vendor. Variances in reference material specifications placed shipments of the company's lead products in jeopardy.

Technical Need

Significant variations in the reference materials caused continuous changes to lot specifications during the manufacturing process. The original assay lacked the required specificity and repeatability due to operator technique subjectivity and insufficient robustness in the product release assay.

Cambridge Biomedical's Service

We listened to the client's need and proposed a plan of action. The client approved the project scope and the project team started efforts at the assay standard material level. We implemented requirements for the vendor to supply reference standards within tight specifications. Scientists redesigned the assay from the ground up, developing strict protocols and metrics, which eliminated operator subjectivity.

Results

With Cambridge Biomedical's assistance, the client was able to manufacture and ship product with confidence, knowing that they had a well understood and robust process that would stand up in the field.