Standardization And Control - Protecting Your People, Product And Reputation

By David Heaney

“It takes 20 years to build a reputation and five minutes to ruin it”. Wise words from Warren Buffet.

And in biopharmaceutical manufacturing, these words certainly ring true.

Process variation or operator error in downstream processing can have huge consequences for biopharmaceutical manufacturers, CMOs (contract manufacturing organizations) and CDMOs (contract development and manufacturing organizations).

If a batch is lost due to contamination through human error, for instance, a manufacturer may not only suffer significant financial losses but more importantly, there may be a market shortage of life-changing drugs that patients depend on. The subsequent damage to a company’s reputation can be enormous.

To operate effectively and serve their customer bases, biopharmaceutical manufacturers, CMOs and CDMOs, therefore, need consistent, defined outcomes.