CMC News and Resources

Expert Insight

Robust Analytics for Novel Modalities: Industry Leaders Share Strategies

As cell and gene therapies, RNA-based platforms, and antibody-drug conjugates accelerate toward commercialization, the pharmaceutical industry must develop analytical methods robust enough to characterize increasingly complex therapeutic modalities while remaining flexible enough to evolve with emerging science. PharmaSource asked analytical

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Expert Insight

Why Early CMC Planning Still Fails—and How to Fix It

“CMC success is rarely the product of last-minute fixes. It comes from embedding strategic foresight, regulatory awareness, and cross-functional collaboration from day one.” — Evelien Stalmeijer Evelien Stalmeijer, Chief Cell & Gene Therapy Consultant at eXmoor Pharma, brings deep expertise

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