Recently, junshi biological third product to achieve commercialization. In its Shanghai Lingang production base, there are more drugs in the clinical trial stage, which are continuously produced through advanced intelligent production lines.
This base pioneered the one-time intelligent production of domestic biopharmaceuticals, the whole process of data exchange, implementation of control, can achieve more efficient and accurate production and quality control. At the beginning of this year, junshi bio's precision distribution scene was also selected into the list of excellent scenes of the national 2021 intelligent manufacturing pilot demonstration factory.
Let's take a look at how smart this factory really is?
"Production in the dark" transforms into "transparent production"
In the traditional biomedical production process, the production process still relies on manual paper and pencil to record, collect, organize and analyze. How can pharmaceutical companies ensure the integrity and consistency of data to the greatest extent, capture every information point in the production process, trace all production processes, and realize real-time tracking and automatic preservation of all data, excluding the interference of human factors?
The digital transformation of the biomedical industry is imminent. To this end, at the beginning of the design of the Shanghai Lingang production base, the informatization team of Junshi Bio learned from the advanced practices that could be implemented at that time and tried to design the factory from an advanced perspective.
"As early as the moment junshi bio decided to land in Lingang in 2016, it was determined to achieve comprehensive digitalization of the plant from design to construction, automate production and manage digital operation into actual production, and strive to achieve a digital factory with four transformations." Xie Wan, deputy general manager of Junshi Biotech and head of Lingang production base, said.
Four transformations, namely, through the digitization of production lines, workshops and factories, the original biopharmaceutical "dark production" is transformed into "transparent production"; through networking, the original biopharmaceutical "data lags behind the product" into "data synchronization is synchronized with the product"; through data analysis and control, the original biopharmaceutical "experience determines quality" into "process assurance quality"; through the overall digitization of "man-machine material legal ring", the original biopharmaceutical "employment management drug quality" is transformed into "" The system guarantees the quality of drugs", so as to ensure the safety of drugs from the source.
Four platforms ensure four 100%
Today, this large-scale modern biomedical industrialization base covering an area of 80 acres has subverted the management mode of traditional biopharmaceuticals, ensured drug safety from the source, and successfully created a digital intelligent manufacturing benchmark in the biopharmaceutical industry.
At the scene, it can be seen that the Lingang production base of Junshi Bio is completely independent of the flow of people and logistics through a corridor in the middle of each division. Xie Wan introduced that this Internet of Things system makes the production building, warehouse and quality center of the base are connected in series, laying the foundation for the automatic transfer of materials.
Digitalization is a systems engineering, so a customized platform is needed to have full control over it. As a result, Junshi Bio Shanghai Lingang Production Base has established a whole-process interaction system for intelligent manufacturing.
This system manages the logistics, production, quality and plant facilities of the whole base, ensures that the materials in the base are 100% timely and error-free, ensures that the production links are 100% accurate and completely controlled, ensures that the quality management is 100% true and completely traceable, and ensures that the factory facilities are 100% prepared and environmentally friendly and energy-saving.
Even in the face of different production modes of different production units at the base, the system can flexibly and efficiently realize the rapid switching of production products and the rapid change of production capacity.
Not only that, after more batch production, through the accumulation of production process data, the digital system will look for the "golden batch curve" - that is, the best situation of cell culture, through the comparison and analysis of production process data, to adjust the changes in the subtle parameters of the production process, and strive to make each batch of production close to the "golden batch curve".
Digitalization brings zero error
In order to improve efficiency and space utilization, the base set up a common liquid dispensing area in the B3 workshop, and provided medium and buffer for the three original liquid production lines. This means that dozens of materials need to be transported from the warehouse to the common dosing area for centralized preparation, and then different kinds of media and buffers need to be transported to different equipment in different production lines on a time basis, and each equipment also has multiple inlet and outlets. After the whole process is operated, the probability of manual error is high.
Therefore, for the production and quality departments, the most prominent demand in this link is to ensure "zero errors" in feeding. Once an error or possible cross-contamination due to material confusion occurs, the entire batch of the drug will be directly scrapped, which will be a high economic loss for the biopharmaceutical enterprise.
In the digital construction of Junshi Bio's Lingang production base, in view of this problem, IT (information technology) and OT (operation technology) are fully integrated, and finally a set of solutions is formed, and bar code has become the key to tracking.
In the material pipeline to the interface and equipment are pasted with the corresponding bar code, the staff scan the bar code, after the system determines the consistency can be carried out follow-up operation, the formation of step-by-step binding, point-by-point verification of the closed-loop operation verification mode. Starting from the above-mentioned barcoding of consumables, the application of barcoding has gradually spread to all aspects of the factory.
In the future, Junshi Bio will further form a digital central control and systematic management and operation mode at the group level on the basis of digital intelligent manufacturing factory, such as establishing a data platform for R&D and production sharing, achieving the goal of continuous process testing, and opening up information channels between different subsidiaries and headquarters in the group. In addition, the base itself is also seeking the coverage and innovative application of 5G technology in the base, keeping up with the trend of digital frontier development.
Text: Chen Shuo
Editor: Ying Zou
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