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.
|Articles|May 1, 2019
Integrated Biologics Development
Catalent Biologics provides advanced technologies and tailored solutions for biologic development from DNA to commercial supply.
Catalent Biologics provides advanced technologies and tailored solutions for biologic development from DNA to commercial supply. Catalent recently commenced a $200-million investment to expand drug substance and drug-product manufacturing capacity at its Madison, WI and Bloomington, IN sites. The expansions were in response to increasing demand from existing and future customers following the company’s 30th commercial product approval.
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