[Editor's Viewpoint of China Pharmaceutical Network] The biomedical industry is a key development area of ​​"Made in China 2025" and a key direction of the national manufacturing power strategy. As the "13th Five-Year Plan" progresses, the policy-oriented "dividends" of the national biomedical industry have doubled. It is reported that in recent years, the "Outline of the Strategic Plan for the Development of Traditional Chinese Medicine (2016-2030)", "Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry", "Several Opinions on Carrying out the "Three Products" Special Actions for the Consumer Goods Industry to Create a Good Market Environment" Other policy documents have been issued, pointing out the direction for the future upgrade of the biomedical industry, and the support for the entire industry’s innovation capabilities, quality brands, smart manufacturing and green manufacturing has continued to increase.

With the rapid development of the biopharmaceutical industry, the bioreactor, as a powerful weapon for the production of the biopharmaceutical industry, will also develop rapidly. Insiders said that bioreactor technology has now become the core supporting technology in the industrial development of biotechnology, and it is also an important factor in determining product quality and cost in the production process of biomedicine. Therefore, enterprises need to continuously practice "internal strength" and improve bioreactor technology.

disposable bioreactor (picture from Baidu picture)

The author has learned that the disposable biopharmaceutical system can reduce the repeated cleaning, sterilization, and disinfection processes in the biopharmaceutical manufacturing process, saving pharmaceutical companies the time of trial and error and production, and has a high success rate. With the continuous progress and development of disposable biopharmaceutical systems, they will begin to replace traditional stainless steel systems and are increasingly favored by biopharmaceutical manufacturers.

Sartorius Product Application Support Manager Yang Wei said, “At present, China is at the right time for rapid development of single-use technology. In the past ten years, both in terms of R&D ideas and processes, single-use technology has become increasingly mature. In today’s China, Under the environment of the development of the pharmaceutical industry, disposable production equipment provides a highly advantageous technology platform. Specifically, the disposable technology is very flexible, and it can produce products of different types and scales to deal with various diseases, indications and multiple diseases. Changing market demand. Moreover, compared with stainless steel equipment, one-off technology greatly reduces the initial investment in fixed assets, and at the same time shortens the cycle of plant construction, thereby reducing overall production costs while improving production efficiency."

From a global perspective, with the rapid development of life sciences and biotechnology, the biomedical industry is becoming one of the world’s fastest-growing emerging industries and the commanding heights of competition among major economies. In China, the biomedical industry is an important part of the national strategic emerging industry. In the next 10 years, the biomedical industry may achieve medium-to-high-speed development. The rapid development of the biopharmaceutical industry is both an opportunity and a challenge for the bioreactor industry. On the one hand, it has brought huge market space to the bioreactor industry, but on the other hand, it has also proposed a higher level to the bioreactor industry. Requirements.

Disposable products have revolutionized the field of bio-manufacturing, and can meet the special professional needs of bio-therapeutic drug development and manufacturing. It is reported that disposable bioreactors-these bioreactors are designed as stirred tank reactors for animal cell culture, using the principles of traditional stainless steel bioreactors to help ensure optimal cell culture performance. These bioreactors fully utilize disposable product contact surfaces, thereby reducing contamination and minimizing cleanup, giving them unique advantages.

The author was informed that Sartorius, a leading international supplier of equipment and services for the biopharmaceutical industry, has developed and produced a new generation of BIOSTAT STR® bioreactor system. The new generation of BIOSTAT STR® bioreactor combined with ambr® 250 technology will significantly shorten the time for process development and process scale-up. Manager Yang Wei said: "These highly scalable single-use bioreactors are a smart, low-risk bioprocess development solution, suitable for multi-product manufacturers and CMO institutions for the production of biological products and vaccines. "

Disposable bioreactor is a new type of technology, which is of great significance for the development of biomedicine. But from the current point of view, it still has certain defects. Therefore, companies still need to continuously carry out R&D and innovation to produce safer, more humane, and more in line with market needs, so as to promote the further development of the biomedical industry.

(Source: China Pharmaceutical Network)