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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue.

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Transforming high-throughput screening with mass spectrometry

Drug Discovery World

HTS as a tool for drug discovery has evolved rapidly since the origin of the technique in the 1990s. Trapped ion mobility spectrometry: Improving the specificity of MALDI-MS-based HTS . Wagner, MALDI imaging mass spectrometry: Bridging biology and chemistry in drug development, Bioanalysis, 2011, 3: 2427–2441, [link].