Recombinant protein expression in the yeast Pichia pastoris is a relatively simple and cost-effective method for production of complex proteins. The manufacturing and purification process of these products leaves the potential for impurities by host cell proteins (HCPs) from P. pastoris cells. 
This simple-to-use, specific and broadly reactive kit is intended for use in determining the presence of P. pastoris protein impurities in products manufactured by recombinant expression in Pichia GlycoSwitch® host cells. The Pichia GlycoSwtich® strains allow for the engineering of human-like glycosylation structures on the protein of interest. This kit is “generic” in the sense that it is intended to react with essentially all of the HCPs that could contaminate the product independent of the purification process. The antibodies have been generated against and affinity purified using Pichia GlycoSwitch® HCPs recovered from conditioned media. The antibodies used in this kit were characterized by Antibody Affinity Extraction (AAE™) and Mass Spectrometry, demonstrating reactivity to 88 -100% of HCPs. The F1015 kit aids in optimal purification process development, process control, and in routine quality control and product release testing.
This new Cygnus Technologies' P. pastoris 3rd Generation HCP ELISA Kit provides the specificity and sensitivity (LOD ~0.2 ng/ml, LLOQ ~3 ng/ml) to detect HCPs with reproducibility that supports regulatory compliance. Please use Sample Diluent, Item No. I028, with these kits; available separately.