GPCM 2013

Experts still out to whether QbD is a suitable route for biologics approval

To QbD or not to QbD? That is the Question...

By Dan Stanton

Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.

Western CMOs Hold Advantages Over East, says PTI

Western CMOs Hold Advantages Over East, says PTI

By Dan Stanton

Cost of freight, customer service and regulatory compliance offer Western CMOs advantages over their Eastern Counterparts, according to US CMO Pharma Tech Industries (PTI).