Since 2020, the biomedical industry has received a lot of attention. A series of policies have been issued from the country to the local area to support the development and growth of the biomedical industry, and the entire industry has ushered in vigorous development. In this context, upstream biopharmaceutical equipment has also received high attention from the market. The industry expects that under the new situation, disposable systems will gradually replace traditional stainless steel reactor equipment.
Recently, the Changsha factory of Truking Siyoute Biotechnology Co., Ltd., a subsidiary of Truking Technology, located in Ningxiang, Hunan, was officially put into operation on the morning of May 12.
The establishment of Truking Siyoute and the construction of its Changsha factory are important steps in the expansion of the product chain layout of Truking Science and Technology, and also one of the important achievements in the investment promotion of the Ningxiang industrial chain and the development of the biomedical industrial chain. Truking Siyoute focuses on the R&D and production of disposable technology and its products, and already has products such as disposable bioreactors, liquid dispensing bags, liquid storage bags and their membrane materials.
In the context of the rapid development of the biomedical industry, the related equipment industry in the industrial chain will also face opportunities and challenges. The industry believes that in the future, disposable systems will gradually replace stainless steel equipment and penetrate into research, clinical and commercial applications. "Compared with traditional large-scale stainless steel bioreactors, the disposable system is more flexible, has a shorter construction period, lower initial investment costs, and higher production capacity, which can accelerate the commercialization process of biopharmaceutical companies."
Single-use mixing technology is used in the pharmaceutical field for mixing homogeneous liquids and solids. It can be roughly divided into three applications: liquid/liquid mixing, solid/liquid mixing and solid/solid mixing.
With the passage of time, single-use mixing systems have become more and more widely used in pharmaceutical processes, and the operating volume has ranged from tens of liters to hundreds of liters, and now it can be as high as thousands of liters; the range of applications ranges from protein drugs to vaccines, etc. A variety of applications; the process points used are becoming more and more critical.
Disposable magnetic stirring liquid dispensing bag is one of the important products independently developed by Truking Siyoute. The special membrane material is the key raw material and key component of this disposable liquid dispensing bag.
Magnetic stirring system is the most commonly used mode of disposable stirring system. The stirring paddle at the bottom of the 3D stirring bag is driven by magnetic force to achieve the mixing effect of liquid/liquid or solid/liquid. The disposable stirring paddle of the magnetic stirring system is built into the stirring bag, which can be divided into two categories: magnetic bearing stirring system and magnetic levitation stirring system.
The stirring paddle of the magnetic bearing stirring system is connected with the bottom of the mixing bag by an inert bearing, and the paddle does not come into contact with the membrane material inside the bag when it rotates. The magnetic levitation system uses superconducting drive. Once a stable magnetic field is formed, the stirring paddle is suspended and rotated for stirring and mixing. The magnetic levitation stirring paddle has no bearings and seals in the bag, so there is no friction between the levitating blade paddle and the bag film material or bearing, and is recognized as an ultra-clean stirring system. It is mainly used in the key process points of preparation filling.
Like mechanical shaft stirring, 3D magnetic stirring bags require a fixed-shaped container for support. Generally, the support container is cylindrical or cubic. From the perspective of mixing efficiency, the cubic support container can bring better mixing efficiency, because the four walls of the cube support container form a natural baffle, which helps to break the laminar flow and expand the mixing range. If the liquid distribution system adopts a cylindrical support container, it is recommended to use the eccentric mode for large volume mixing, that is, the eccentric position of the stirring blade at the bottom of the mixing bag.
As more and more drugs are commercially produced, disposable dosing systems that can cover the full volume are becoming more and more important.
In recent years, the entire medical field in China is ushering in a rare opportunity for development. However, in the midst of rapid development, industry insiders and investors have also discovered that in the entire upstream industry chain of the medical field, China still has many deficient subdivisions.
At present, more than 20 biopharmaceuticals and vaccines manufactured using one-time production technology in China's pharmaceutical field have been approved by FDA, EMBA and other countries and regions to enter clinical trials. There are 3~5 commercial GMP production plants that have been built or are under construction around the world, using advanced disposable production equipment, such as CRUCELL, ITERO, and BIOINVENT, etc. FDA also recognizes and supports the development of disposable technology.
As an important part of the single-use production system, industry insiders pointed out: "Once the drugs produced using single-use production technology are approved by the FDA and other regulatory agencies, in commercial production, single-use equipment will be more expensive than those that are fixed and expensive." The stainless steel production system has stronger competitiveness.
For domestic companies, finding manufacturers that can provide domestic alternatives in a timely manner is not only to reduce costs and reduce procurement troubles, but also to take precautions to ensure the security of the company and even the country.
Source: New Industry Insights