Cleaning-in-place of immunoaffinity resins monitored by in situ ATR-FTIR spectroscopy.

ABSTRACT: In the next 10 years, the pharmaceutical industry anticipates that revenue from biotherapeutics will overtake those generated from small drug molecules. Despite effectively treating a range of chronic and life-threatening diseases, the high cost of biotherapeutics limits their use. For biotherapeutic monoclonal antibodies (mAbs), an important production cost is the affinity resin used for protein capture. Cleaning-in-place (CIP) protocols aim to optimise the lifespan of the resin by slowing binding capacity decay. Binding assays can determine resin capacity from the mobile phase, but do not reveal the underlying causes of Protein A ligand degradation. The focus needs to be on the stationary phase to examine the effect of CIP on the resin. To directly determine both the local Protein A liga

SUBMITTER: Boulet-Audet M 

PROVIDER: S-EPMC4551555 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature