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- Early CDMO engagement: balancing speed with flexibility in CMC planningBringing a new therapy to the clinic requires clinical, non‑clinical, regulatory and CMC activities to move forward together. In early development, having drug material available is often on the cr…
- Study shows low extractables in single-use components support ADC manufacturingCytiva conducted extractables testing on disposable chromatography column housings and flow kits used in antibody-drug conjugate production. The tests used dimethylacetamide (DMA) and dimethyl sul…