Manufacturing
Pilot Plant
Hongcheng Lingang Pilot Plant
- The Hongcheng pilot production base is named Shanghai chengmu Pharmaceutical Co., Ltd. Chengmu pharmaceutical CMC production platform locates at E2 workshop, building 26,356 ZHENGBO Road, Fengxian District, with a building area of 6359.80 square meters. The future plant is the pilot scale production base that will provide biological products or materials that support phase I and phase II clinical trials. The base can fulfill the production capacity of a variety of products, with the functional production capacity of four upstream bioreactors and two downstream production lines - 1st 200L upstream production line (for IND);2nd 200L upstream production line (for IND); and 500L / 2000L upstream production lines (for Phase II & III). They are all clinical products prepared by disposable technology. At the same time, the base has a product vial filling line (solution or lyophilized powder 6000 vials / batch).
- In the production base, we also have the capabilities of building GMP main cell bank and working cell bank. The QC laboratory, with good quality management system, can release, characterize and test clinical stock solutions and preparation products.
- The CMC production platform of Chengmu pharmaceutical is a technology transfer platform (PC / technology transfer) supporting the pharmaceutical section of bio-drug IND declaration and future commercial production. The pilot plant will transform the clinical research of at least three projects into commercial production products in one year. The plant will be completed and put into use in September 2022.
Commercial Manufacturing
Hongcheng Kangqiao Commercial Manufacturing Base
- The commercial production base of Shanghai Hongcheng Biopharma is located in the southern area of Kangqiao Industrial Zone, Xinchang Town, Pudong New District, with a total land area of about 59.5 acres and a planned construction area of about 80,000 square meters. Construction has started in January 2022 and is expected to be completed in December 2023, and GMP certification will be completed in December 2024 to achieve industrialization.
- The base is composed of a comprehensive building, three production buildings, supporting warehouses, an energy distribution center and other buildings. The overall production capacity is mainly composed of 2-3 3*2000L production lines (Phase 1) and 4 3*5000L (Phase 2) raw solution production lines for biomacromolecule innovative drugs; 2 300v/min vial filling lines (solution, Freeze-drying) and a 300v/min pre-filled needle production line, with a maximum annual production capacity of 36 million preparations. One-time construction of supporting elevated three-dimensional warehouse and energy distribution center has been completed. In the base, we have also planned a main cell bank and a working cell bank with GMP standards.The advanced QC laboratory is responsible for product release, and a complete quality management system will be established to ensure product quality.
