Journal of Bioprocessing & Biotechniques

John P Welsh

Publications

• Research Article
  Demonstrating β-glucan Clearance in CHO- and Yeast-Produced Monoclonal Antibodies during Downstream Purification Processes
  Author(s): Fengqiang Wang, Hong Li, Zhi Chen, John P Welsh, Douglas Richardson, Jennifer M Pollard, Daisy Richardson and Mohammed ShameemFengqiang Wang, Hong Li, Zhi Chen, John P Welsh, Douglas Richardson, Jennifer M Pollard, Daisy Richardson and Mohammed Shameem
  
  Biologics production using yeast or CHO with Yeastolate as cell culture additives often introduces β-glucan, which could potentially pose immunogenicity risk, if not adequately removed. Although a previous study has shown the effective clearance of Yeastolate-derived β-glucan by Protein A chromatography, the clearance pattern of yeast cell derived β-glucan remains unknown. In this study, we characterized the β-glucan clearance patterns during downstream processing of three monoclonal antibody (mAb) products, one mAb fragment from Pichia pastoris (mAb A) and two full mAbs from CHO expression system (mAb B and mAb C), by Glucatell assay. We demonstrated effective β-glucan clearance in both small (100 L) and large scale (5000 L) batches of mAb A as well as in one batch of mAb B. Protein A purification step removed an average of 97.74% (1.7 log10 reduction) of .. Read More»
  DOI: 10.4172/2155-9821.1000185

  Abstract PDF