CELL BANKING

CDMO provides MCB, WCB, and EOPCB banking service in compliance with European EMA, and Chinese NMPA GMP regulatory requirements.

• Dual-site cell bank storage
• Dedicated cell banking suite
• Real-time cell bank monitoring system and safety management measures

PROTEIN RELATED DRUG DS/DP MANUFACTURING

CDMO offers manufacturing services including cell culture by using disposable bioreactors, purification, formulation, fill/finish (both liquid and lyophilized) and package of drug product. State-of-the-art equipment ensures product to be consistently produced with high quality.

• cGMP Production facilities are fully in compliance with GMP regulations
• Multiple production scales at 50L, 200L, 500L, 1,000L and 2,000L implementation of disposable equipment to reduce cross-contamination risks and shorten production cycles
• Quality management system ensures GMP compliance.

ADC DS/DP MANUFACTURING

CDMO is the one of the leading companies for ADC drug development in the world that provides technically challenging service from development to commercial production including both payload and ADC. CDMO is equipped with state-of-the-art fill/finish equipment with aseptic filling and lyophilization with automated operation to ensure manufacturing with efficient control. Innovative linker/payload technologies are implemented to ensure product with good therapeutical window and safety. Robust ADC manufacturing process produces ADC with consistent drug to antibody ratios (DAR).

• Large scale linker/payload synthesis under GMP conditions
• Broad range of conjugation scales
• GMP fill/finish of ADC products

PRODUCT TESTING

Product testing/release, specification setting are based on EMA, NMPA filing principles and ICH guidelines and life cycle management.

• In Process Testing and Control: Titer, Protein Concentration, Osmolality, Bacterial Endotoxin, Sterility and so on.
• Release Testing: for DS/DP release testing, comprehensive assay will be performed, such as identity, purity/impurity, potency, protein strength and safety test, general test, etc.
• Stability Study: Long Term Stability, Accelerated Stability, Forced Degradation Stability Test and In-use Stability, etc.