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COMMERCIAL MANUFACTURING · 2,000–5,000L

Commercial manufacturingCommercial Manufacturing

Rooted in China and looking to the world. To build ultra-large-scale, first-class manufacturing capacity for global market expansion, Zencore has completed a large-scale commercial manufacturing base in Lingang (Linjia Base): its two drug substance production lines are equipped with 3×2,000 L single-use bioreactors and 3×5,000 L stainless-steel bioreactors respectively, reaching the 20,000 L+ ultra-large-scale tier and now in operation to serve Phase III clinical and large-scale commercial manufacturing. An even larger 6×15,000 L production line is also in preparation.

3×2,000 L single-use line3×5,000 L stainless-steel line6×15,000 L in preparationNMPA · FDA · EMATransparent manufacturing
Back to Biologics CDMO Services
20,000L+
Ultra-large-scale production lines in operation
0.5–12g/L
Broad processing capability across a wide range of protein expression levels
5–15%→1%
Substantially lower process failure rate with single-use systems
6×15,000L
Even larger production lines in preparation
Site Vision

Positioning of the commercial baseBuilt for Global Supply

In view of diverse future client needs and Zencore's vigorous global business expansion, Zencore'sThe first commercial manufacturing basewill be built into:

01comply with NMPA, FDA and EMA standards
02"data-driven", aligned with the "Industry 4.0 pathway"
03Degree of automationIndustry-leading
04world-leadingFacility design, equipment and instruments
05Covering and meetingGlobal supply chain system
Zencore's commitment is to provide clients with"transparent manufacturing"- clients can participate in and track every detail of their product's manufacturing throughout. Our future facility designs provide the hardware foundation for delivering on this commitment.
Architectural rendering of Zencore's Lin-gang Commercial Manufacturing Facility
Linjia Base · Zencore Biologics Lin-gang Commercial Manufacturing Facility
Two Dedicated Lines

Two drug substance production linesDrug Substance Lines

Zencore has invested significantly in commercial manufacturing equipment: the 2,000 L line uses a hybrid single-use and stainless-steel configuration, while the 5,000 L line uses an all-stainless-steel system. This balances production flexibility, reduces process failure risk and lowers manual-operation and supply-chain maintenance risks that could affect production quality and timelines.

Single-Use Hybrid

3 × 2,000 L single-use lines

A hybrid production line combining single-use bioreactors with downstream stainless-steel systems

technical requirements
  • Flexible product changeover
  • Low failure rate
  • Highly automated
  • Controllable cost
  • Flexible processes
Specific features
  • Wider processing capability: suitable for expression levels from 0.5 g/L to 12 g/L
  • easily adapted to any client's process
  • Comprehensive formulation and bulk management
  • Integrated electronic batch records available
  • Expandable PAT functionality
Technology selection
  • Bioreactors: single-use 3×2,000 L
  • Solution preparation and intermediate storage: stainless steel plus single-use
  • Downstream purification equipment: stainless steel plus single-use
All Stainless Steel

3 × 5,000 L stainless-steel lines

Fully stainless-steel upstream and downstream facilities, with single-use bioreactors

technical requirements
  • High production efficiency
  • Low failure rate
  • Highly automated
  • Low cost
  • appropriate process flexibility
Specific features
  • Advanced bioreactor process control
  • Single-use bioreactors and a hybrid downstream production line
  • Usable from 0.5 g/L to 12 g/L
  • easily adapted to any client's process
  • Comprehensive formulation and batch management
  • Integrated electronic batch records available · expandable PAT functionality
Technology selection
  • Bioreactors: stainless steel 3×5,000 L
  • Solution preparation and intermediate storage: stainless steel
  • Downstream purification equipment: stainless steel

Preparing for Phase III clinical and commercial supply

20,000 L+ dual single-use and stainless-steel production lines, transparent manufacturing and a global supply chain - joining you on the path to product launch.

Inquire about commercial manufacturing