Response of a concentrated monoclonal antibody formulation to high shear.

  title={Response of a concentrated monoclonal antibody formulation to high shear.},
  author={Jared S Bee and Jennifer L Stevenson and Bhavya C Mehta and Juraj {\vS}vitel and Joey Pollastrini and Robert D. Platz and Erwin Freund and John F. Carpenter and Theodore W. Randolph},
  journal={Biotechnology and bioengineering},
  volume={103 5},
There is concern that shear could cause protein unfolding or aggregation during commercial biopharmaceutical production. In this work we exposed two concentrated immunoglobulin-G1 (IgG1) monoclonal antibody (mAb, at >100 mg/mL) formulations to shear rates between 20,000 and 250,000 s(-1) for between 5 min and 30 ms using a parallel-plate and capillary rheometer, respectively. The maximum shear and force exposures were far in excess of those expected during normal processing operations (20,000 s… CONTINUE READING
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