Great insights into Advanced Process Controls expanding in the Biopharma industry by Saly Romero-Torres and team.

Key takeaways:

• The fundamental controls techniques (FDC, SPC, R2R, etc.) used in Semiconductor manufacturing apply in Pharmaceuticals

• FDA regulations make applying active controls difficult, and new guidelines need to be adopted (ICH Q12)

• Use of Advanced Process Controls are a critical enabler to faster, cheaper, more reliable drug manufacturing