Zencore Biologics has made an important progress in joining the global CDMO market by commissioning its first-in-class cGMP manufacturing facility in China at the end of 2022.,. The phase-I facility has 3x2,000L (single use) and 3x 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 demands for drug manufacturing. For phase II expansion, an additional 6x15,000L production capacity has been planned. These manufacturing facilities are designed to manufacture phase III to commercial products and compliant with international facility construction and regulatory guidelines.
To meet the needs of our global customers, Zencore 's commercial facility is designed and constructed to meet the requirements:
• NMPA, FDA and EMA regulation
• "Data-driven analytics" to accommodate "Industry 4.0 "
• Industry-leading automation
• Supply chain and logistics for global market
We are committed to providing our clients with "Transparent Manufacturing" options. Clients will be able to track production progress starting from initial tech transfer activities to product release. Software and hardware infrastructure in the new manufacturing facilities will enable seamless communication.
We have invested in the 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 as stainless steel bioreactor line which will significantly lower the COGS. Phase Ⅰ facilities are designed with the flexibility in mind to accommodate client processes.
Flexible and convenient product change over
Low failure rates
Highly automated systems
Cost efficiency
Flexible process
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