Assessment of cleaning procedures of a biotherapeutic manufacturing process
AssigneeAmgen Inc.
InventorRammahipal Kouda
Life of this patent
Estimating the term…
Abstract
Provided herein are methods of assessing or validating a cleaning procedure of a biotherapeutic manufacturing process, said method comprising analyzing by a surface plasmon resonance (SPR)-based assay the binding activity of a cleaned sample to a ligand which binds to a biotherapeutic produced by the manufacturing process. In various embodiments, the cleaning procedure comprises one or more steps to inactivate and/or degrade the biotherapeutic. In various instances, the method demonstrates that greater than about 99.99% degradation of the therapeutic is achieved by the cleaning procedure comprising the one or more steps to inactivate and/or degrade the biotherapeutic.
Claims25
A cleaning validation assay for a biotherapeutic manufacturing process, comprising:
- determining the binding activity of a cleaned sample to a ligand by a surface plasmon resonance (SPR)-based assay, where in the which binds to the biotherapeutic produced by the biotherapeutic manufacturing process wherein the cleaned sample is obtained by carrying out a small-scale cleaning procedure, which simulates a large-scale cleaning procedure, on a sample comprising the biotherapeutic, wherein the cleaning validation assay has a limit of detection (LOD) that is less than 20 ng/mL.
A method of assessing a cleaning procedure of a biotherapeutic manufacturing process, comprising:
- a. carrying out a small-scale cleaning procedure, which simulates a large-scale cleaning procedure, on a sample comprising the biotherapeutic produced by the biotherapeutic manufacturing process, to obtain a cleaned sample,
- b. determining the binding activity of the cleaned sample to a ligand which binds to the biotherapeutic, wherein the binding activity is determined by a surface plasmon resonance (SPR)-based assay, which correlates the binding activity to a concentration of the biotherapeutic;
- and
- c. determining the concentration of the biotherapeutic of the cleaned sample based on the binding activity determined by the SPR-based assay.
Dependencies are inferred from the claim text.