English to Polish Medical Medical: Pharmaceuticals

Może chodzi o "dopuszczenie do obrotu"?

The methods provided herein also can be used as release or stability assays for quality control (QC) purposes. For example, methods as described herein can be used to test antibody production lots, wherein the presence of ADCC activity or the level of ADCC activity is used to certify the antibody product as meeting quality control guidelines (e.g., in GMP (Good Manufacturing Practice) or other standards). In some cases, the mere presence of ADCC activity can be used as a qualitative determination that an antibody meets quality control guidelines and is suitable for release. Such methods thus can require no interpretation beyond a determination that impedance is decreased in the presence of the antibody being tested. In some embodiments, a sample of the lot of an ADCC antibody to be certified can be deliberately degraded and used as a negative control for comparison with the antibody lot to be released. The real time ADCC readout curve for the two samples can be compared, and a quantitative or qualitative cut-off can be established for quality control certification. The exact concentration-dependent response and assay parameters can be determined by trial and error.
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18. A quality control assay for an antibody, comprising: (a) monitoring the impedance between electrodes on a non-conducting substrate that supports the growth of target cells in an assay medium; and (b) adding effector cells and the antibody to the assay medium, wherein the antibody binds to the target cells; wherein a decrease in the impedance between the electrodes on the substrate following addition of the effector cells and the antibody is indicative that the antibody is suitable to be released for use in ADCC induction, and wherein an increase or no change in the impedance between the electrodes on the substrate following addition of the effector cells and the antibody is indicative that the antibody is not suitable to be released for use in ADCC induction.