Biochemical Assays, Cell Based Assays and Drug Development

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Biochemical Assays

Cell Based Assays

Drug Development

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

For example, in describing how potency should be demonstrated for CGT products, the 2011 guidance simply stated that potency for gene therapy products is derived from “at least two biological activities for its potency: the ability to transfer a genetic sequence to a cell; and the biological effect of the expressed genetic sequence.”

Production

Production FDA Therapies Biochemical Assays

Transforming high-throughput screening with mass spectrometry

Drug Discovery World

OCTOBER 14, 2022

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].

Synthetic Chemistry

Synthetic Chemistry Cell Based Assays Biochemical Assays Analytical Chemistry

Drug Discovery Digest

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Transforming high-throughput screening with mass spectrometry

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