This case chronicles the challenges of establishing an innovative tissue bank service to accelerate the research and development processes of biotechnology and pharmaceutical companies worldwide. Asterand’s two major challenges involved achieving a standardized approach to collecting tissue samples in hospitals all over the world and achieving the highest possible quality of tissue samples shipped to their primary customer, Amgen. Despite the identified need for high-quality tissue samples, Asterand was experiencing multiple quality control problems in their processes and procedures. Tissue samples were being packaged poorly, labeled incorrectly or delivered at the wrong time or to the wrong place. Additionally, there were quality issues with the RNA analysis of the samples, which was a critical factor in the usability of the tissue sample for research and development of new therapies and drugs. The head of pathology at Amgen’s California facility was threatening to terminate their existing order and communicate the failure of Asterand to all company employees, which would have a devastating ripple effect across the industry and likely destroy opportunities for any future orders with Asterand. If this happened, Asterand would not be able to secure contracts with customers and was at risk of losing investors and going bankrupt.
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