Case Study: Dendreon achieves right‑first‑time, paperless PROVENGE production with MasterControl Manufacturing Excellence (Mx)

How a digital manufacturing solution embeds quality into cellular therapeutics production

Dendreon, a pioneer in cellular therapeutics and maker of the FDA‑approved autologous immunotherapy PROVENGE, faced the challenge of delivering personalized treatments within a tight, time‑sensitive window. Paper batch records, siloed teams across multiple sites, and manual review processes risked delays or errors that could prevent patients from receiving their therapies on time.

Dendreon implemented MasterControl Manufacturing Excellence (and later Quality Excellence) to digitize batch records, embed quality into manufacturing, and enable real‑time collaboration with review‑by‑exception. The solution removed paper from cleanrooms, unified manufacturing and quality workflows, cut review and release time by nearly 50%, and preserved a 99% right‑first‑time release rate.

Dendreon

Nadeem Sheikh

Vice President Manufacturing and Research Sciences