2,000-5,000L Commercial Manufacturing Facility

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.

3 X 2,000L
  • Technical Specifications
    • Flexible and convenient product change over

    • Low failure rates

    • Highly automated systems

    • Cost efficiency

    • Flexible process

  • Specific Characteristics
    • 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

  • Technology Advantage
    • Bioreactor:Single use, 3x2,000L production line

    • Solution preparation and intermediate storage: Stainless steel + single use

    • Purification equipment:stainless steel + single use

3 X 5,000L
  • Specific Characteristics
    • 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

  • Technical Specifications
    • High productivity

    • Low failure rate

    • Highly automated

    • Low cost

    • Process flexibility for customers

  • Technology Advantage
    • Bioreactor: stainless steel, 3 x 5,000L

    • Solution preparation and intermediate storage: stainless steel

    • Purification equipment: stainless steel

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