Highly advantageous

perfusion culture platform

Manufacturing Process

We are one of the few pharmaceutical companies in China who are capable of applying perfusion cell culture technology to long-term, large-scale commercial manufacturing.We have established an industry leading CHO cell-based perfusion culture platform.

The production scale of bioreactor Cells in culture can be kept for up to 120 days, which is 5-10 times higher than the efficiency of the batch culture process.

The company has an experienced manufacturing staff and has established a strong biologics production quality control system which ensures the rapid industrialization of products with stringent closed-loop quality management.

Highly advantageous perfusion culture platform

  • Minimizing the degradation of target proteins
  • The cells in culture can be kept for up to 120 days
  • Perfusion culture technology is five to ten times more efficient compared to fed-batch culture technology
  • Requiring significantly less capital investment up front to build the manufacturing facilities
  • Lower operating costs for manufacturing the same product yield as compared with fed-batch bioreactors
  • Perfusion culture technology enjoys obvious advantages in cell culture efficiency and product quality

Production process of PUK

The manufacturing process of PUK can be divided into two phases: raw material manufacturing and formulation manufacturing. Regarding these processes, raw material manufacturing is more time consuming and formulation manufacturing takes less time.

Raw material manufacturing: Mainly completed in the cell culture workshop and purification workshop. Starting from CHO cell recovery, cell culture fluid is obtained through seed culture expansion and large-scale cell perfusion culture, and the intermediate is obtained after multi-step purification of cell culture fluid. The intermediate is then subjected to virus removal and purification steps to form a stock solution, completing the raw material manufacturing phase. The stock solution is stored at low temperatures and has a certain validity period.

Formulation manufacturing: The formulations are mainly produced in the formulation workshop. The stock solution and auxiliary materials are prepared, sterilized and filtered to give a semi-finished product, and then the finished product is obtained by filling, lyophilization, capping and packaging. The stock solution, semi-finished product and finished product shall be sampled by the QA department and sent to the QC department for testing. The products can only be sold after passing the tests and being released by the QA department.

CHO Cell Recovery

Seed Culture Expansion

Perfusion in Bioreactor CHO

Multi-step Purification

Final Drug Product

Manufacturing Operations