ADC Service
Core Services:
● Linker+Payload pool for XDC drugs development.
● Antibody-drug conjugation process development.
● GMP production of ADC Drug Substance.
Core Strengths：
● Mature Technology Platform:Scalable, milligram-to-kilogram production of highly potent APIs for R&D, pilot and commercial use.
● Quality Integration for Split Manufacturing:For cross-site production of DS and DP, we provide complete technical solutions including analytical method transfer, quality standard alignment and process bridging validation to reduce cross-facility quality risks.
● Global Regulatory Compliance Capability: We are proficient in the requirements of major regulatory authorities including NMPA, FDA, and EMA. With 20 years of industry experience in DMF filing, IND applications, and commercial registration, we provide full-cycle regulatory support to accelerate project approvals.
