Office of New Drug Quality Assessment ONDQA

United States

Office of New Drug Quality Assessment ONDQA

United States

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Shapiro M.A.,Office of Biotechnology Products OBP | Shapiro M.A.,U.S. Food and Drug Administration | Chen X.-H.,Office of New Drug Quality Assessment ONDQA | Chen X.-H.,U.S. Food and Drug Administration
American Laboratory | Year: 2012

Antibody-drug conjugates (ADCs) are both drug and biological molecules. The three components of an ADC include the mAb, the cytotoxic small drug molecule, and the linker. The characterization, manufacturing process controls, comparability, release, and stability assays need to be appropriate for the entire molecule. The identity and purity release methods for the ADC often include the same methods used for the mAb intermediate. Size variants, such as aggregates and fragments should be controlled. Levels of free antibody should be determined. The potency assay for an ADC should demonstrate cytotoxicity specific for an antigen positive tumor cell line. Stability testing should include an assessment of free drug and stability indicating methods related to the mAb. The potency assay for the mAb intermediate typically measures antigen binding. If the mAb provides additional MOA, more than one potency assay should be considered.

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