Manufacturing
Overview

Capacity

Production Line

Competitive Advantage

Capacity
  • Drug Substance Capacity: 22,300 L capacity in operation; 90,500 L capacity is in planning

  • Drug Product Capacity: a vial fill finish line (liquid/lyophilized) with 10 million/ year capacity; a prefilled syringe line with 10 million/year capacity

  • Filling line for 90,000L  Drug Substance is in planning

  • Media Production Capacity: 200 tons/year media powder

  • ADC Production Capacity: have 10 ~ 100L glass reactors, 2×50L and 2×200L stainless steel reactors. 2×500L stainless steel reactors are in planning

Production Line
  • Pilot Production (Drug Substance): 2×200L GMP production line, 1×500L GMP production line, 2×200L Non-GMP production line

  • Commercial production (Drug Substance): 3× 2,000L single use production line, 3×5,000 L stainless steel production line

  • Commercial production (Drug Product): lyophilization production line, vial filling production line, prefilled syringe production line

  • Media production line: Zencore has a cGMP & ISO13485 certified mediua dry powder production line, the manufacturing capacity is from 1kg to 1200 kg, and has 200 tons/year media production capacity, which can support media production from preclinical to clinical stage. 

  • ADC production line: The pilot production lines for drug substance :2×10L, 2×20L, 2×50L, 2×100L meet cGMP requirements. The commercial drug substance manufacturing has 2×200L production lines that meets cGMP requirements, and another 2×500L production lines that is in preparation; It has pilot-scale drug product vial filling and 5m2 lyophilization production line that meet the requirements of cGMP. And commercial preparations of vial filling and 20m² lyophilization production line.

Competitive Advantage
  • Six major R&D and manufacturing facilities are located at Zhoupu Medical Valley, Lin-gang Life Blue Bay in Shanghai, China, and Maryland, USA (within the FDA, NIH and NIST regions).

  • Zencore provides integrated services from preclinical research to commercial production for domestic and foreign pharmaceutical companies, boosting and accelerating the global bio-pharmaceutical R&D and industrialization process.

  • The company has a wide range of R&D capabilities, covering pharmaceutical evaluation, cell line development, upstream and downstream process development, analytical method development, and medium formulation development in the bio-pharmaceutical industry.

  • Core business  cell line development and media customization have a strong competitive advantage in the industry. Collaborate with leading enterprises in media industry to expand business and capacity.

  • With strong production capacity, the total production capacity is 22,300L. And an additional 90,500L planned in the future.

  • Versatile drug product lines, Aseptic Vial Filling, Lyophilization, Prefilled Syringe can be performed.

  • Lin-gang Pilot Manufacturing Facility

    Business Capability:

    Pilot production for Phase I & II clinical trials;

    Production Scale:

    cGMP: 1×500L, 2×200L;

    Non-GMP: 2×200L;

    Space:

    10,000 ㎡

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  • Lin-gang Commercial Manufacturing Facility

    Business Capability:

    Phase III & commercial production;

    Production Scale:

    DS manufacturing: 3 x 2,000L; 3 x 5,000L, 500L perfusion

    Fill/finish

    Space:

    66,000 ㎡

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  • ADC

    Manufacturing Facility​

    Business Capability:

    Pilot production for Pre-clinical, Phase I & II clinical trials;

    Phase III & commercial production;

    Production Scale:

    ADC pilot & commercial production:

    2 × 50L LDPE reactor;

    2 × 200L LDPE reactor;

    1~100L glass reactor;

    Fill/finish:

    1 x 5 m² lyophilizer;

    1 x 20 m² lyophilizer;

    Space:

    6,400㎡

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