The drug substance production line is equipped with mammalian cells and microbial expression system platforms, comprehensively covering the production needs of diverse products including eukaryotic, prokaryotic, vaccine, and oncolytic viral products. The facility has been systematically designed using the Quality by Design (QbD) concept, strictly adhering to GMP standards established by the NMPA, FDA, and EMA. Through a robust quality management system, it ensures efficient and controllable production processes while implementing advanced data integrity assurance measures and information security protection systems, thereby providing comprehensive safeguards for pharmaceutical production quality.

• 6 sets of single-use bioreactors (50L/500L)
• 2 sets of 2000L single-use bioreactors
• Bioreactors support fed-batch and perfusion culture modes

• Custom-built stainless steel reactor trains (20L-300L-3300L)
  
• Capable of high aeration rates and agitation speeds
  

• Single-use system (max 2000L)
  
• Stainless steel system (max design capacity 3000L)

• GEA continuous-flow centrifuge (production-scale)
• Depth filtration system (>20 m²)
• Pro600-scale chromatography columns
  
• Large-scale ultrafiltration systems