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Recombinant expression in BL21(DE3) E. coli is a relatively simple and cost-effective method for production of certain therapeutic proteins. The manufacturing and purification process of these products leaves the potential for contamination by host cell proteins (HCPs) from BL21(DE3) E. coli strain. Reduction of HCP impurities to the lowest practical level is a regulatory requirement.

Cygnus BL21(DE3) HCP ELISA Kit, F1060, has been developed to aid in optimal purification process development, process control, routine quality control and product release testing.

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• Based on a broadly reactive anti-BL21(DE3) HCP Antibody detecting over 90% HCPs as determined by Antibody Affinity Extraction and Mass Spectrometry.
• Provides the specificity and sensitivity (LOD ~0.4 ng/ml, LLOQ ~3 ng/ml) to detect HCPs with reproducibility that supports regulatory compliance.
• Robust simultaneous protocol with time to results in under 3 h.

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InVivoKines™ are a new generation of recombinant fusion proteins for immunotherapeutic, preclinical and translational in vivo research, developed in-house by AdipoGen Life Sciences. InVivoKines™ are Fc-based fusion proteins using the Knobs-into-Holes (KIH) technology.

InVivoKines™ Quality Features

• Native Conformation − Production in HEK 293 or CHO Cells
• Production under Animal-Free Conditions
• High Bioactivity tested by ELISA/Cell-based Assays
• Verified Purity & Homogeneity by SEC
• Low Endotoxin Levels
• Batch-to-Batch Consistency