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- MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concernsAt The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
- 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…