Regulatory Focus™ > News Articles > 10 > The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

Posted 04 December 2018 | By Satish Kumar MohanveluJessica Shea 

In recent years, pharmaceuticals have become more complex, progressing from primarily small molecule drugs to an increasing array of recombinant proteins, monoclonal antibodies and cell and gene therapies. This has led to necessary changes in regulations to accommodate new, more complex manufacturing processes that have more steps and are more sensitive to variability and contamination. ….Read the full white paper


This article is sponsored and does not reflect the views or opinions of RAPS.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe