Molecular Design

SEPTEMBER 18, 2024

In the Compatibility Issues section the authors state: Looking beyond laboratory-to-laboratory variability of assays that are nominally the same, there are numerous reasons why literature results for different assays measured against the same “target” may not be comparable.

Biochemical Assays 69

Biochemical Assays Biophysical Assays Drugs Cell Based Assays 69

Molecular Design

DECEMBER 19, 2023

Regardless of whether binding to target is covalent or non-covalent, the concentration and affinity of substrates (as well as cofactors such as ATP) need be properly accounted for when interpreting effects of chemical probes in cell-based assays. As measurement of k.inact/K.i values for a covalent chemical probe.]

Small Molecule 66

Small Molecule Biochemical Assays Cell Based Assays Drugs 66

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 40

Production FDA Therapies Biochemical Assays 40