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Integrated technology platforms for monoclonal antibody drugs

United BioPharma possesses a full-range monoclonal antibody drug development technology platform, enabling independent, efficient, cost-effective mAb drug development prior to early-stage clinical trial without outsourcing to external organizations.
This integrated technology platform is the foundation of new drug pipelines. United BioPharma is able to create a new mAb drug using internal expertise and capabilities of research and development, as well as by licensing the cutting-edge research targets from academic institutes upon comprehensive and in-depth evaluation.
• Protein monoclonal antibody development technology

Antibody genetic engineering, construction of high-yield cell line for industry use, serum-free cell culture and cell line adaptation, construction and optimization of manufacturing process of mammalian cell culture, protein antibody structure analysis, biochemistry/physical/chemical property analysis, construction of protein drug quality control system.

• Protein monoclonal antibody manufacturing technology
Construction of GMP mother cell bank (MCB) and working cell bank (WCB) and contract analysis, fermentation of mammalian cell, protein/monoclonal antibody purification, design and validation of viral removal during the purification process, cleaning and validation of manufacturing process and equipment, active pharmaceutical ingredient (API) and drug product stability testing, API/drug product quality control system, sterile injectable filling, validation and quality testing of intermediate manufacturing process.