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Cell And Gene Therapy Definitions
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The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This article discusses the definitions of the above process components based upon statements to be found in recent regulatory guidance documents. Examples from cell and gene therapy processes are given. Read it here.
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By Siddharth Krishnan
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When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.
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CDMO Playbook: How Early Partnerships Cut Rare Disease Costs
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Article | By Dr. Rebecca Abram and Dr. Joanna Norman, FUJIFILM Biotechnologies
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To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.
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Cell 2026 | 12-13 November, London, UK
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Advanced therapy development moves fast, and the companies shaping it are the ones connecting science, scale and strategy in the same room. Cell 2026 is where that happens. Partner with us to reach 800+ senior pharma, biotech and R&D decision-makers through guaranteed 1:1 meetings, speaking slots, roundtables and tailored digital campaigns. Get in touch and we'll design a package around your objectives.
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