Anubhav Arora
Director, Discovery CMC Apellis Pharmaceuticals
I’m a senior CMC leader with 20+ years of progressive R&D experience, including 16+ years in pharmaceutical drug substance and drug product development and manufacturing across peptides, oligonucleotides (siRNA, gRNA, mRNA), small molecules, and biologics. My work sits at the intersection of science, execution, and strategy—building scalable CMC solutions that move complex programs from concept through clinical development and commercial launch.
I bring deep expertise in GxP, quality systems, and regulatory‑ready execution, and I’m known for building and leading high‑performance teams across internal organizations and global partner networks. I’ve repeatedly built capabilities from the ground up, leveraging lean, virtual, and outsourced operating models to deliver robust manufacturing and supply strategies under aggressive timelines.
As a collaborative and data‑driven leader, I partner closely with research, regulatory, quality, supply chain, and executive teams to align CMC strategy with enterprise objectives—enabling informed decisions, accelerating development, and reducing risk in highly complex therapeutic modalities.
Seminars
- How are emerging mRNA modalities in CGT changing the biggest process development and CMC challenges teams need to solve today?
- Where are current analytical and control strategies falling short when applied across diverse mRNA-enabled CGT applications – and how should they evolve?
- What does a truly scalable and flexible CMC framework look like when supporting multiple mRNA-driven CGT modalities with differing requirements?
