Domestic First Set of 20,000 Liter Stainless Steel Bioreactors: The Optimal Choice for Cost-Effective Biopharmaceutical Production
Jul 12, 2024
With the vigorous development of the biopharmaceutical market in recent years, the competition in the global biopharmaceutical field is becoming increasingly fierce, and the focus of industry competition is also increasingly focused on improving productivity. On May 18, 2024, Sherpa Biotech announced the official operation of the new Hangzhou base. In accordance with the cGMP standards of China NMPA, the US FDA, and the European EMA, the first 20,000-liter stainless steel bioreactor in China (a total of four sets) has been successfully built, and a single tank body spans the entire two-story intelligent factory. The new factory has introduced a large number of advanced intelligent equipment, achieving full automation of the production execution system, and with its excellent stability, superior cost-effectiveness, and advanced digital intelligence, it can flexibly meet the personalized needs of different projects, which will greatly improve the production efficiency of the project and reduce production costs.
One of the main advantages of the stainless steel bioreactor system is its excellent stability. The system used by Sherpa Biotech all uses austenitic stainless steel SS316L material, which fully complies with technical specifications and international standards, and its design and verification follow ISPE GAMP5. This material has the characteristics of corrosion resistance, high strength, and high-temperature resistance, and has excellent biocompatibility, which can better avoid the interference of polymer materials that may affect the production process efficiency and inhibit cell growth (such as bDtBPP), becoming the risk of process-related drug impurities, further improving the quality of the drug and ensuring patient safety. In addition, the batch-to-batch differences or fluctuations of stainless steel materials are also smaller, which is conducive to further improving the robustness of the process and increasing the production success rate.
Although the stainless steel bioreactor system requires a higher initial investment, its long-term durability can greatly help customers reduce production costs. In the environment of commercial large-scale production, the stainless steel bioreactor system can significantly reduce equipment replacement and reduce the demand for disposable materials, thereby reducing production and operation costs, showing a high cost-effectiveness. Sherpa Biotech's new Hangzhou base is equipped with the first single-tank volume of 20KL stainless steel bioreactor in China (a total of four sets), with a production capacity of 80KL, which not only meets the large-scale commercial production needs of customers but also helps customers greatly reduce production costs, providing customers with stronger production expansion capabilities.
Sherpa Biotech's stainless steel bioreactor system deeply integrates advanced digital intelligent production technology, which not only greatly improves production capacity but also leads the new trend of intelligent manufacturing, making the large-scale production process more efficient and smooth. The system achieves integrated control through MES (Manufacturing Execution System) linkage with multiple automation systems. Through precise system control, equipment parameters and product shelf life are strictly managed, which greatly reduces manual checks and cumbersome records, effectively improving production efficiency. At present, Sherpa Biotech's stainless steel bioreactor system has completed dozens of projects at different stages, producing hundreds of batches of products, all of which have been successful, providing strong support for the smooth approval of the project.
In summary, choosing the right production system is crucial for ensuring a high-quality, high-output production process and achieving a superior cost-effectiveness ratio. The stainless steel bioreactor system has shown many advantages in the field of antibody production, such as sustainability, cost-effectiveness, process and quality controllability, and environmental friendliness. These advantages together provide customers with a more reliable and efficient production solution. Sherpa Biotech is committed to providing partners with high-quality antibody preparation services, making full use of the advantages of the stainless steel bioreactor system to help partners stand out in the fiercely competitive pharmaceutical market.
Americ Energy (CHINA) Co., Ltd. stands as a prominent manufacturer and distributor of a comprehensive range of stainless steel products, designed to cater to the diverse needs of various industries. Their offerings encompass stainless steel tubes, plates, strips, and square tubes, all manufactured to uphold the highest quality benchmarks.
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