| abstract |
The present invention relates to methods of operating chromatographic columns in anti-TNF antibodies, such as anti-TNFα antibody SIMPONI® (golimumab), and methods of making certain pharmaceutical compositions of such antibodies. The method includes collecting column exit signals and cumulative flow parameters of at least one mobile phase transition front at two or more intervals during operation of a chromatography column comprising column packing. . A model gamma cumulative distribution curve is determined based on the cumulative flow rate parameter and the column exit signal collected for at least one mobile phase transition wire. The theoretical plate equivalent height (HETP) value is calculated for at least one mobile phase transition wire using the parameters of the model gamma cumulative distribution curve, and the quality of the chromatography column packing is evaluated based on the calculated HETP value. During routine column monitoring, if adverse trends in HETP are observed or control limits are exceeded, elution product quality, column process performance, and/or impurity removal data to ensure product quality for the identified batch. Should be evaluated. If any of the product quality or column performance does not pass the set of criteria, appropriate calibration activities such as conditioning, repacking or replacement of the column, and qualification should be performed prior to release for further use. |