Capacity
Production Line
Competitive Advantage
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 90,000 L Drug Substance is in planning.
Media Production Capacity: 200 tons/year media powder.
ADC Production Capacity: 10 ~ 100 L glass reactors, 2×50 L and 2×200 L stainless steel reactors. 2×500 L stainless steel reactors are in planning.
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.
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
Pilot production for Phase I & II clinical trials;
cGMP: 1×500L, 2×200L;
Non-GMP: 2×200L;
10,000 ㎡
Lin-gang Commercial Manufacturing Facility
Phase III & commercial production;
DS manufacturing: 3 x 2,000L; 3 x 5,000L, 500L perfusion
Fill/finish
66,000 ㎡
ADC
Manufacturing Facility
Pilot production for Pre-clinical, Phase I & II clinical trials;
Phase III & commercial production;
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;
6,400㎡
20400 Century Blvd, Suite 100, Germantown, MD 20874, USA
+1(240) 243-6179
Bldg 16 (C4), 356 Zhengbo Rd, Lin-gang Special Area, Shanghai, China
+86-21-6818 9888
201318
Bldg 6, 860 Xinyang Rd, Lin-gang Special Area, Shanghai, China
+86-21-6818 9888
201419
289 Zhengjia Rd, Lin-gang Special Area, Shanghai, China
+86-21-6818 9888
201419
Bldg 31 (F1), 356 Zhengbo Rd, Lin-gang Special Area, Shanghai, China
+86-21-68189888
201413
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