
Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.
Combining high performance protein A capturing and a single polishing step on a salt-tolerant anion exchange resin, downstream costs were reduced by 45% in this Tosoh 2-step process for mAb purification.






