Leads Biolabs has established a highly integrated and efficient antibody drug development platform including process development (cell culture, protein purification, and FFF), analytical method development, quality control and pilot GMP DS production in Nanjing Biotech and Pharmaceutical Valley.​​​​​​​

Leads Biolabs has established a lifecycle quality management system from discovery and development through manufacturing and delivery, which complies with all applicable standards and regulations adopted by the U.S. Food & Drug Administration (FDA) and the China National Medical Products Administration (NMPA).
We have advocated and practiced such a principle: Quality is everyone’s resposibility so that we can consistently deliver innovative medicines that are safe, effective and accessible.​​​​​​​

Our medical team develops product development and registration strategies based on the project characteristics. Our goal is to achieve differentiated deployment and highly efficient clinical development in China and globally. We actively communicate with China NMPA, US FDA and other drug regulatory agencies during the clinical process to ensure the high standards of studies and obtaining approval.​​​​​​​