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Disposable closed biological manufacturing system may be a future direction
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Disposable closed biological manufacturing system may be a future direction.
Disposable technology is favored by more and more biopharmaceutical companies due to its “efficient, safe and flexible” process characteristics.
With the development of the biopharmaceutical industry, the disposable process technology has undergone continuous innovation and matured day by day.
Nowadays, biopharmaceuticals have gradually transformed into a closed biomanufacturing system, in which disposable process technology plays an irreplaceable role.
In today’s biopharmaceutical production, whether it is more traditional biological products such as monoclonal antibodies, vaccines, serums, or new processes such as cell and gene therapy (see Figure 1), the safety, effectiveness and flexibility of production are all biopharmaceuticals.
Indispensable for business. In response to these demands, fast, safe, and economical one-off process technologies have emerged, bringing many conveniences to pharmaceutical production, and are gradually being recognized by the global biopharmaceutical market.
Figure 1 Technical requirements of biopharmaceutical manufacturing industry
Looking back at the development history of disposable process technology (see Figure 2), we have experienced a period of triggering and vigorous development of technology.
With the improvement and stability of technology and craftsmanship, the change of mainstream users, and the gradual improvement and improvement of production requirements and regulations, it has inevitably entered the bottleneck period of technology.
Figure 2 The development of disposable technology
According to the BioPlan survey report on biopharmaceutical production capacity and output from 2012 to 2018 (see Figure 3), it can be seen that the proportion of disposable process technology in process development, scale-up, and clinical production has been greatly reduced, while in commercial production The application of it has been improved year by year.
This shift has brought about the gradual shifting of users’ attention to compliance, cost optimization, and productivity improvement, which puts forward higher standards for disposable technology, and thus brings new changes in technology and work patterns. challenge.
Figure 3 Application trend of disposable products (2012-2018)
Correspondingly, as a manufacturer of disposable products, it is also necessary to establish relevant GMP control measures in response to changes in customer needs:
1. Strict control of the product supply chain:
- Supplier qualification review
- Improve supply chain transparency
- Improve the manufacturing environment
2. Strict control of production materials:
- The manufacturing material of the product
- Product production equipment material
- Filter material
3. Strict compliance with laws and regulations:
- Process certification and verification to ensure that it can be applied
- Quality risk assessment, such as system integrity
- Change control
The impact of disposable technology on costs (see Figure 4) is mainly divided into two parts. The increased input of consumables will increase the storage cost, but at the same time increase the output and accelerate the launch of the project.
Conversely, one-off technology can reduce investment in fixed assets, public works, and verification costs, thereby reducing investment risks.
Figure 4 Cost influencing factors of disposable technology
Therefore, the general trend of the market is to simplify operations. The core is two questions:
① How to further simplify the process and save costs?
② How to use the existing old workshop to be compatible with one-off processes?
This puts forward a new concept of closed systems, the closed manufacturing system (Closed manufacturing system), that is, to adopt appropriate environmental control measures to minimize the risk of pollution.
The acceptance criteria depend on environmental quality, testing frequency and production steps and conditions.
Under the background of pursuing high efficiency, high yield and safety, the industrial production method of biopharmaceuticals has gradually changed from an open system that exposes products and is difficult to control to a functional closed system, and ultimately leads to drugs and products that are never exposed during the production process.
The closed system transformation in the environment. Eventually, the traditional workshop (see figure 5 top) develops to the ball room (see figure 5 bottom).
Traditional workshop VS ball room
Figure 5 Traditional workshop layout (top) and ball room workshop layout (bottom)
Different from open systems (products are exposed to the environment, the environment controls product quality), or functional closed systems (systems are regularly opened but produced in a closed state), closed manufacturing systems rely entirely on disposable technology to achieve the entire The system is closed, sterile and safe.
Therefore, the closed system will greatly save the cost caused by environmental control, and it will also have great compatibility with the environment.
The existing monoclonal antibody process usually has about 14 unit operations, but these unit operations are like islands, and the closed system connects these islands in series, so it simplifies the operation The complexity of the system, taking into account the use requirements of different application scenarios, and reducing the investment of workshop personnel.
With the demand for new biological processes and the emergence of new biological products, the advantages of disposable closed systems have become more obvious. Some biological products, such as oncolytic viruses or whole-cell vaccines, cannot be used to obtain final products due to their relatively large molecules, which require higher environmental control. The one-time closed system can solve this problem well.
In addition, some personalized treatment programs, such as cell therapy, have a large number of patients but a small amount of products per person.
During the construction of the workshop, it is impossible to build a clean workshop for each product. At this time, a closed system can be used for workshop layout. .
In addition, it has been proposed that using a disposable closed system, traditional biological drugs, such as monoclonal antibodies, can we produce in the same workshop or in-line, or even whether we can produce in a CNC environment, which will greatly reduce the construction of the workshop.
Investment and maintenance costs, while improving the flexibility of the production line.
So, how do we build a one-time closed system? First of all, we need to have a full understanding of our own process, because the entire process system is divided into many steps, there are many different materials in and out, the entire process needs to be fully designed.
Then for different steps and needs, choose the appropriate disposable equipment and consumables. Subsequently, it is necessary to select a suitable connection scheme and flow path design, and connect individual equipment and consumables in series according to the process flow to form a completed production system.
Disposable closed systems have many advantages, but of course there are also challenges. The biggest problem is how to ensure that the built system is closed. In order to reduce risks, the first choice of disposable equipment and consumables must be guaranteed.
Suppliers must have a complete quality system to ensure that the products they provide are safe and meet regulatory requirements.
At the same time, there must be a certain detection method to ensure that after the assembly of the production system is completed, there is no leakage and no risk of contamination.
The disposable closed system has become a development direction for the production of biological products in the future, and will provide a powerful solution for the cost reduction and efficiency enhancement of medicines.
Disposable closed biological manufacturing system may be a future direction
(source:internet, reference only)