April 19, 2017

The Cost and Impact of a Bioburden Incident


Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. Apart from the potentially tragic impact on patients, the economic consequences of a batch failure are enormous. For the mAb blockbusters, a one-month production stop can result in lost revenues of up to US$1 billion. A typical QA investigation could cost US$ 20,000. These are big and scary numbers.

There are, however, solutions for decreasing the risks. Read more in the blog article.


Tags: Protein A, monoclonal antibodies, Mabs, contamination, microbial, bioburden