perfusion culture platform
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.
Tasly Biopharma has built a production workshop that meets GMP standards and began to independently produce the company’s core product, PUK, in 2011. The company has the capabilities of long-term continuous culture of mammalian cells to express target proteins for large-scale commercial production of biologic drugs. The company has formulated “Production Management Procedures” to control the overall production and management process. The Production Director is directly in charge of product production, which consists of a process equipment department, a production department and an engineering department. Among them, the process equipment department is responsible for the management of workshop equipment, technology research and development equipment and quality inspection equipment, the production department is responsible for the daily management of production activities in the cell culture workshop, purification workshop and formulation workshop, and the engineering department is responsible for the management of all public equipment/facilities and plant facilities except for the process equipment. The cell culture workshop, purification workshop and formulation workshop are divided into sections for production. Each section is equipped with corresponding technicians, and each workshop is equipped with a workshop supervisor or workshop manager for specific management.