As the "heart" equipment in the field of biomanufacturing, bioreactors are the core carriers for microbial and cell culture as well as product preparation, widely used in the production and research of antibiotics, amino acids, biomedicine, new materials and other fields. For a long time, the core technologies of high-end bioreactors such as parallel reactors and animal cell reactors have been monopolized by foreign enterprises, forcing domestic research institutions and enterprises to purchase imported equipment at high prices. Today, local enterprises represented by Shanghai Divoxin focus on independent R&D, and a variety of high-performance bioreactors have achieved technological implementation and mass production, breaking the bottleneck in industry development, promoting China's biomanufacturing equipment towards localization, intelligence and flexibility, and laying a solid equipment foundation for the high-quality development of the biomanufacturing industry.
The rapid development of synthetic biology has ushered in an explosive period of front-end innovation in biomanufacturing. With the help of gene editing and automated platforms, researchers can construct hundreds of high-yield strains a year, achieving a qualitative leap in R&D efficiency. In sharp contrast, however, the downstream strain verification link has fallen into a predicament of "holding back". The traditional shake flask culture method has problems such as small sample processing capacity, rough parameter control, poor experimental repeatability, and difficulty in horizontal comparison of data, leading to the burial of a large number of potential strains and the difficulty in rapid transformation of front-end innovation achievements, which has become a key bottleneck restricting the development of the biomanufacturing industry. At the same time, industrial fermentation production has strict requirements on the compliance, accuracy and stability of equipment. Fermentation equipment meeting CGMP standards has long relied on imports, further increasing the cost of industrial localization.
Faced with the dual pain points of industrial scientific research and industrialization, domestic local enterprises have accelerated technological tackling. Enterprises represented by Shanghai Divoxin Bioengineering Co., Ltd. have deeply engaged in the bioreactor field for 16 years. With years of technological accumulation, they have built a complete bioreactor system equipment system covering the entire scenario from laboratory research to industrial production, becoming the backbone of the domestic bioreactor field. On the laboratory end, the multi-connected glass fermenters and parallel bioreaction equipment launched by Divoxin have achieved the dual advantages of miniaturization and high parallelism. The equipment can be directly placed on ordinary experimental platforms, and a single unit can realize the synchronous operation of multiple independent reaction units. Each unit can accurately control core culture parameters such as temperature, pH, dissolved oxygen and stirring. Equipped with a German Siemens PLC control system and a full Chinese operation interface, it realizes real-time recording, storage and remote transmission and analysis of experimental data, reducing the strain performance test that used to take weeks to several days, greatly improving data reliability and comparability, and perfectly meeting the needs of high-throughput strain screening in the era of synthetic biology.
On the industrial production end, Divoxin's automatic fermenter series covers everything from 5L laboratory models to 5000L industrial models, among which the 50L-1000L fermenters meeting CGMP standards have become the main equipment in fields such as biomedicine and vaccine production. This series of equipment adopts a 316L stainless steel tank with an internal polishing precision of Ra≤0.4, equipped with a complete air intake and exhaust treatment system such as an air intake sterilization filter and an exhaust condenser. The double-seal design at the upper shaft end or the lower magnetic stirring design achieves zero leakage, ensuring the sterility of the culture system from the source. At the same time, it is equipped with Mettler high-precision PH and DO electrodes and load cells. Through intelligent PID control, it realizes precise regulation of pH, dissolved oxygen and fermentation broth weight. The multi-channel ventilation design combined with a thermal mass flow meter enables automatic and precise control of air and oxygen flow, fully meeting the strict requirements of industrial biomanufacturing production. In addition, in accordance with the requirements of FDA, WHO and China's new GMP, Divoxin can provide customers with one-stop turnkey engineering services from equipment R&D, process design to engineering installation, commissioning and maintenance, tailor-made complete process solutions, and solve various personalized problems of customers in the process and production.
In addition to core fermenter equipment, Divoxin has also built an upstream and downstream complete product system. Its medium preparation system adopts a modular design, integrating medium preparation tanks, stirring, pipelines and control systems into one, supporting sidewall sampling, automatic recording and network upload of process parameters, meeting the sterility requirements of liquid preparation systems, and widely used in the biopharmaceutical industry. Special equipment such as CIP cleaning tanks and vaccine fermenters realize technical customization for different application scenarios. For example, vaccine fermenters can realize in-situ automatic sterilization of empty and full tanks, with precise control of sterilization temperature and time. Parameters such as pH and dissolved oxygen are equipped with real-time and historical curves, which can directly output batch reports, fully matching the compliance and refinement requirements of vaccine production. The landing of these equipment has filled the "qualitative gap" between traditional shake flasks and industrial fermenters, made the connection between laboratory research and industrial production smoother, and truly become an important bridge connecting laboratories and factories.
The large-scale landing of high-performance domestic bioreactors is not only valuable in improving scientific research efficiency and reducing enterprise procurement costs, but also in escorting the industrialization of biomanufacturing. In the biomanufacturing industry, strains need to go through multiple rounds of process optimization and scale-up verification from "being able to produce" in the laboratory to "mass production" in the factory. If the early experimental data is inaccurate and the culture process is uncontrollable, it is easy to lead to the failure of later scale-up production, resulting in huge waste of human, material and financial resources. The high-quality and scalable process data provided by domestic equipment represented by Divoxin can effectively reduce the trial-and-error cost and risk of industrialization, and accelerate the transformation process of innovative achievements from the laboratory to industrialization. With the deepening dependence of industries such as biomedicine, green chemicals and functional foods on biomanufacturing, the market demand for intelligent, efficient and localized bioreactor equipment continues to rise. The technological breakthroughs and product landing of domestic equipment not only break the import monopoly, but also firmly grasp the equipment initiative of the biomanufacturing industrial chain, providing a solid guarantee for the safe and stable development of the industry.
At present, domestic bioreactors have achieved a technological breakthrough from "0 to 1", and moving from "usable" to "easy to use" and "willing to use" has become the core challenge for the next development of the industry. Industry enterprises said that in the future, they will continue to optimize equipment reliability, software operation experience and after-sales service, while strengthening in-depth adaptation with upstream and downstream processes to improve the comprehensive adaptability of equipment. Local enterprises represented by Shanghai Divoxin will also continue to deepen technological R&D, keep up with the industry development trend, promote bioreactors to integrate more intelligent technologies, such as function upgrades based on AI process prediction, remote monitoring and automatic feedback adjustment, and make the equipment evolve towards a more flexible and intelligent direction.
Driven by both policy support and market demand, the localization process of China's biomanufacturing equipment continues to accelerate. The technological exploration and product practice of local enterprises represented by Divoxin have accumulated valuable experience for the R&D and application of domestic high-end bioreactors, and also provided ideas for the subsequent core technology tackling of more high-end equipment such as animal cell reactors. With the continuous improvement of the R&D strength of local enterprises, domestic bioreactors will gradually realize the transformation from following to keeping pace with and leading the world, providing solid equipment support for China's biomanufacturing industry to rank among the world's top.
in conclusion:Localization Breakthrough of Bioreactors: Driving China’s Biomanufacturing Upgrade
China's localization of bioreactors, led by enterprises like Shanghai Divoxin, has broken foreign monopolies and built a full system from lab research to industrial production, meeting CGMP standards for high-throughput screening and large-scale manufacturing. These domestic devices bridge lab-to-factory gaps, cut costs, and reduce industrialization risks. Now focused on upgrading from "usable" to "user-friendly," they integrate AI and smart technologies. With policy and market support, domestic reactors are advancing globally, securing China's industrial initiative and solidifying its position in world-class biomanufacturing.
