Recently, my colleagues and I worked with a BioPharmaceutical Manufacturing company to apply predictive analytics methods to solve a critical product quality problem. We were looking for root cause(s) of this complex problem.
The company manufactures vaccines under strict regulatory guidelines for sterile manufacturing and packaging environments.
The Problem: Specifically, in an important part of the process in which they manufacture one of the active ingredients for a vaccine, they were scrapping about 30% of batches.
Conservatively, scrap at this level resulted in millions of dollars