Zencore Biologics has made significant progress in entering the global CDMO market by commissioning its first-in-class cGMP manufacturing facility in China at the end of 2022. The Phase I facility features 3×2,000L (single-use) and 3×5,000L (stainless steel) production suites with separate purification lines. Zencore will add 21,000L of commercial production capacity in total to meet the ever-increasing demand for drug manufacturing. For Phase II expansion, an additional 6×15,000L production capacity is planned. These manufacturing facilities are designed to support production from Phase III clinical trials to full commercial-scale manufacturing and are compliant with international facility construction and regulatory guidelines.
• NMPA, FDA, and EMA regulations
• "Data-driven analytics to accommodate Industry 4.0"
• Industry-leading automation
• Supply chain and logistics for the global market
We have invested in best-in-class commercial production equipment to provide our clients with superior service. The 2,000L production line is designed as a single-use bioreactor line, and the 5,000L production line is a stainless steel bioreactor line, which will significantly lower COGS. The Phase I facilities are designed with flexibility in mind to accommodate client processes.
Flexible and convenient product changeover
Low failure rates
Highly automated systems
Cost efficiency
Flexible processes
Single use bioreactor and downstream stainless steel system hybrid production line
A wider range of processing capacity compatible with expression levels ranging from 0.5g/L to 12g/L
Easily configurable to client process
Comprehensive production recipe management and batch management
Integrated electronic batch records
Extendable PAT functionality
Bioreactor：Single use, 3x2,000L production line
Solution preparation and intermediate storage: Stainless steel + single use
Purification equipment：stainless steel + single use
Stainless steel equipment in both upstream and downstream
Advanced bioreactor in-process controls
Single-purpose bioreactors and complex downstream production lines
Accommodates titers between 0.5 g/L to 12.0 g/L
Easy to configure to fit client's needs
Comprehensive automation and digitization for the production management
Integrated electronic batch records
Extendable to PAT functionality
High productivity
Low failure rate
Highly automated
Low cost
Process flexibility for customers
Bioreactor: stainless steel, 3 x 5,000L
Solution preparation and intermediate storage: stainless steel
Purification equipment: stainless steel
