• High-throughput Fully Human Monoclonal Antibody Development Integrated Platform HitmAb®
  • High-Efficiency Antibody Expression CHO-GS Cell Platform
  • Process Development Platform
  • Bioanalytical Platform

High-throughput Fully Human Monoclonal Antibody Development Integrated Platform HitmAb®

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Platform Technical Features
The "High-Throughput Fully Human Monoclonal Antibody Development Integrated Platform HitmAb®" is the company's proprietary core technology for fully human monoclonal antibody development, capable of efficiently screening antibody molecules and identifying drug candidates. Built upon the HitmAb® platform, the company has established an independent, high-efficiency antibody screening system that meets technical requirements for key steps in antibody screening, including antigen design, flow cytometry sorting, gene amplification and sequencing, and cell transfection.

The HitmAb® platform isolates single B cells or plasma cells to obtain specific antibody expression genes for large-scale production and screening of monoclonal antibodies. The fully human monoclonal antibodies produced using this technology undergo natural maturation and expression entirely within the human body, offering core advantages such as low immunogenicity, high specificity, high affinity, and superior safety. This technology platform effectively overcomes the time-consuming, labor-intensive, and complex challenges associated with traditional antibody expression (e.g., vector cloning), achieving high throughput and efficiency. The monoclonal antibodies derived from the HitmAb® technology platform are fully human antibodies matured through the selection of the human immune tolerance environment. They minimize the endogenous immunogenicity of antibody drugs and address the challenge of anti-drug antibody (ADA) responses in clinical applications. Compared to antibodies from library or transgenic animal technologies, they provide enhanced safety assurance for patients.

High-Efficiency Antibody Expression CHO-GS Cell Platform

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Platform Technical Features
The "High-Efficiency Antibody Expression CHO-GS Cell Platform" is an optimized monoclonal antibody (mAb) production system based on CHO-GS cells. It boasts two core advantages: high-efficiency expression and antibiotic-free residue, laying a technical foundation for the company to produce high-purity antibodies at lower production costs. This cell system features both antibiotic-free residue and high-efficiency expression.

Process Development Platform

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Platform Technical Features
The "Process Development Platform" integrates critical development stages such as cell culture processes, antibody purification processes, formulation development processes, and antibody quality analysis. It accelerates CMC (Chemistry, Manufacturing, and Controls) development and has successfully scaled up multiple projects from pilot to commercial production.

Bioanalytical Platform

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Platform Technical Features
The "Bioanalytical Platform" is a key technological platform developed by the company through its long-term research in fully human monoclonal antibodies. It enables efficient detection of specific critical parameters for fully human monoclonal antibodies, providing sensitive and specific analytical methods for non-clinical studies (such as pharmacokinetics, toxicology, and pharmacodynamics in monkeys, mice, rabbits, and dogs), as well as for various stages of clinical research. This platform allows for scientific, reliable, and comprehensive evaluation of systemic drug exposure, in vivo activity, and immunogenicity. Specific analytes include drug concentrations in blood or tissues, biomarkers, anti-drug antibodies (ADA), and neutralizing antibodies against drugs (NAb).