Recombinant expression in BL21(DE3) Escherichia coli (E. coli) is a common, effective, and economical method for producing therapeutic proteins. However, the manufacturing and purification processes may be contaminated with host cell proteins (HCPs) from the BL21(DE3) E. coli strain, and this contamination must be strictly controlled. Reducing HCP impurities to the minimum level to meet regulatory requirements is a crucial regulatory task.

Cygnus has recently launched the BL21(DE3) HCP ELISA Detection Kit (Catalog No.: F1060), which is specifically designed for this purpose. It is suitable for detection scenarios such as purification process development and optimization, process control, routine quality control, and product release.

Features and Advantages:

· Based on broadly reactive anti-BL21(DE3) HCP antibodies, it can detect more than 90% of HCPs through antibody affinity purification and mass spectrometry (AAE-Mass).

· It exhibits high specificity and high sensitivity (with a LOD of approximately 0.4 ng/ml and an LLOQ of approximately 3 ng/ml), along with excellent repeatability.

· It adopts a one-step detection method, enabling the acquisition of experimental results within 3 hours.

Product Information

Cygnus Technologies, LLC. provides products and analytical methods for the biotechnology and biopharmaceutical industries, aiming to accelerate the research and development (R&D) phase and improve product quality. The bioprocess residue kits developed and manufactured by Cygnus are used to detect specific impurities in more than 50 different expression systems. As an expert in high-sensitivity analytical technologies focused on immunoassays for biotechnological applications, Cygnus' products and services have been used by nearly all major biopharmaceutical companies for over 25 years.

As the general agent of Cygnus in China, Beijing Ximeijie Technology Co., Ltd. has established long-term and stable cooperative relationships with numerous well-known domestic pharmaceutical companies and CRO/CMO enterprises. Over the years, Ximeijie's products and services have helped many enterprises accelerate the R&D phase, improve the quality, purity and safety of drugs, speed up the optimization of R&D processes, shorten product time-to-market, and reduce QC costs.