“CDMOs are partners with deep, extensive technical expertise that can be leveraged strategically—not just a restaurant where you pick from a menu.” Marta Kijanka, founder of MK Bioconsultancy, is a strategic project manager and CMC consultant who guides early-stage biotech
Carole Delauney warns that sterile injectable manufacturing “is not just fill-finish”—a misconception that can cost biotech companies millions and even derail entire drug development programs. She notes, “This is unfortunately not commonly recognized in the industry, but it is a
“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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