Qualifizierung von Chromatographiesäulen in Herstellungsverfahren zur Herstellung von Anti-Tnf-Antikörperzusammensetzungen

Details

Veröffentlichungs-Nr.

EP4752543

Anmeldetag

19. April 2019

Veröffentlichung

3. Juni 2026

Rechtsraum

EP

IPC

G01N30/56

Abstract

The present disclosure is directed to a method of operating a chromatography column in methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNFα antibody SIMPONI^® (golimumab), and specific pharmaceutical compositions of the antibody. This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is determined based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. The height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value. If during routine column monitoring, an adverse trend in HETP is observed or the control limits are exceeded, the eluate product quality, column process performance, and/or impurity removal data should be evaluated to ensure product quality for the identified batch. Should any of the product quality or column performance fail the criteria set, appropriate corrective action, such as conditioning, repacking or replacing the column, and qualification should be performed prior to release for further use.

Anmelder

Firma

Janssen Biotech, Inc.

Land

🇺🇸 USA