GMP Manufacturing
GMP Manufacturing
Clinical Manufacturing

Relying on Henlius’ abundant experience in technology transfer, clinical manufacturing, and registration of monoclonal antibodies, bispecific antibodies, fusion proteins and other projects, Aton can help customers complete the pilot scale-up of production processes, the production of non-clinical and clinical research drugs and IND application with lower investment, less time and higher fault tolerance rate.

Using a combination of disposable production technology and stainless-steel production equipment, Aton has formed an efficient and stable production platform. For shared equipment, effective cleaning procedures, and monitoring and evaluation of cleaning can reduce the contamination risk in the collinear production of different products.

  • There are 3 cell culture lines (200 L*2; 500 L*2; 200 L*1+500 L*1) with disposable bioreactors, 3 downstream production lines in Fed-batch mode and 1 intelligent continuous production line
  • DP has the capability of liquid filling and lyophilization, compatible from 2R to 50R specifications
  • Has successfully completed the technology transfer of 20+ clinical application projects and has established a scale-up model from 5 L to 200 L/500 L
  • Bilingual in Chinese and English, batch production records that meet the requirement of the GMP document system
  • Completed 100+ batches of 200 L&500 L non-clinical and clinical batch production

Commercial Manufacturing

Xuhui Facility and Songjiang First Plant of Henlius have started commercial operation with a total capacity of 48,000L, and the total capacity is planned to reach 144,000L in 2026. Meanwhile, Henlius started construction of Songjiang Second Plant in 2019. The first phase of the project is planned to have a total capacity of 96,000L, of which 36,000L is expected to be put into commercial operation by the end of 2024.

Henlius will rationally allocate and dynamically adjust manufacturing capacity planning according to marketing demand and continue to explore the maximum utilization of capacity and technology. The plan is to allocate 24,000L of Xuhui Facility to Aton for commercial orders at the end of 2024, which will further accelerate Aton’s global GMP standard manufacturing layout, enable Aton to realize efficient connection from early clinical production to commercial production, and strive to meet the needs of global customers and improve the project delivery capability with experienced manufacturing and quality team.


Quality System

Aton has established a whole life cycle quality system from R&D to commercial production. It follows the basic principle of "quality first" and refers to relevant laws and regulations of the mainstream market (China, EMA, US-FDA) and other quality guidelines for drug R&D and manufacturing, such as WHO, ICH and PDA.

The quality strategy of Aton is progressive quality control, and different levels of cGMP control requirements are implemented in different stages of drug production. Start from the R & D end to implement step-by-step enhancement, and fully comply with cGMP control requirements in clinical phase III. Progressive quality control not only realizes product safety control, but also avoids excessive quality cost investment in the early stage and ensures cost optimization.