The biomedical industry is a strategic emerging industry related to the national economy and people's livelihood. As a new generation of digital production technology, biomedical intelligent manufacturing has been proposed by the national "14th Five-Year Plan" for the development of the bioeconomy and other policies, and has become an important direction for the transformation and upgrading of the biomedical industry. This paper starts from the study of the background and significance of the intelligent transformation of the biomedical industry, introduces the goals of the intelligent transformation of biomedical enterprises, and puts forward relevant countermeasures and suggestions to accelerate the promotion of high-end and intelligent biomedical industry in China.
*: China Institute of Machinery).
1. The background and significance of the intelligent transformation of the biomedical industry
The world is currently facing a new industrial revolution with the core idea of enabling integration between the virtual and real worlds through various elements that will allow for greater automation and digitization of processes. Intelligent manufacturing is a new generation of information technology and advanced manufacturing technology deep integration, based on artificial intelligence, big data, Internet, robots comprehensive application, throughout the whole process of research and development, production and management, with self-learning, self-perception, self-adaptation of the new production mode, for the reconstruction of the biomedical industry chain, to achieve intelligent, flexible, integrated transformation has a very important role and significance.
1.1. Construction of digital value chain.
Technological advancements in the biopharma industry are leading the speed and scale of digitalization in every way, and innovative drugs are becoming more complex, expensive, and challenging. Intelligent manufacturing can empower the whole life cycle management of drug R&D, production, quality, logistics, etc., and on this basis, support the continuous optimization of the operation and management of pharmaceutical enterprises. In order to achieve this goal, pharmaceutical companies will transform the process-oriented management system into a digital-oriented management system, explore the establishment of a digital governance model in line with their own development model, and implement digital transformation at each stage of the drug discovery, clinical trial, supervision, manufacturing, commercialization and monitoring process, so that the drug value chain and product life cycle perspective can be combined, and it is possible to integrate the system, equipment and other links, so as to optimize the allocation of biomedical industry resources and industrial layout. Realize the improvement of industrial competitive advantage.
1.2. Give full play to the unique advantages of intelligent manufacturing.
The integrated development of intelligent manufacturing and pharmaceutical industry is an important measure to solve the bottleneck problem, which is of great significance for promoting the intelligence, informatization and traceability of drug manufacturing, which can not only greatly solve the innovation bottleneck of all links in the industrial chain, promote the improvement of the core research and development capabilities, intelligent equipment technology, manufacturing chain quality and efficiency of the enterprise, and then break the "low-end lock" trap of the industrial value chain, but also promote the transformation of physical production and manufacturing to virtual production and manufacturing, forming an intelligent manufacturing model with virtual and real interaction and two-way effect. Support traditional manufacturing to move towards intelligent manufacturing, and drive the improvement of enterprise production efficiency. Drug quality and safety is the foundation of the biomedical industry, and biomedical intelligent manufacturing will minimize human interference in the production process, promote the high compliance of GMP and the traceability of the whole life cycle of products, and significantly shorten the product research and development cycle, improve production flexibility, ensure the stability of drug quality, and accelerate the realization of import substitution, so as to further enhance the international competitiveness and voice of China's biomedicine.
1.3. Leading the gathering of the biomedical industry.
Industrial agglomeration is a process of high concentration in a specific geographical area and the convergence of capital elements in a specific spatial range, and industrial agglomeration plays an important role in national competition.
The intelligent transformation of the biomedical industry is not only to form a natural selection mechanism of "survival of the fittest" with a competitive self-strengthening mechanism, but also to attract and derive new enterprises with scale advantages by encouraging various forms of cooperation, improve the competitive advantage of regional "clusters", and achieve efficient networked interaction and cooperation in the industrial chain. Therefore, as an important supporting force for cluster development, intelligent manufacturing in the biomedical industry is the highland of regional industrial innovation and the core carrier of industrial development, and plays an important role as a "bridgehead" in undertaking the transformation of innovation achievements, the cultivation of small and medium-sized enterprises, and enterprise services, which plays an important role in cultivating and expanding a large number of leading enterprises in biomedical intelligent manufacturing, promoting the construction of the industrial chain and the linkage innovation of product technology, and helping the biomedical industry to achieve high-quality development.
Second, the goal of intelligent transformation of biomedical enterprises
2.1. Empower biomedical R&D and innovation.
With the rapid development of computer science and technology, artificial intelligence, big data and biomedicine have complemented and promoted each other in recent years, and computer-aided drug design has become one of the main technical methods for innovative drug research. In July 2022, the "14th Five-Year Plan for the Development of the Pharmaceutical Industry" jointly issued by 9 departments including the Ministry of Industry and Information Technology clearly stated that it will promote the systematic upgrading of pharmaceutical manufacturing capabilities, empower pharmaceutical R&D with a new generation of information technology, promote the deep integration of information technology and production and operation, and actively develop new models and new formats. During the "14th Five-Year Plan" period, we will explore the application of artificial intelligence, cloud computing, big data and other technologies in the field of R&D, improve the discovery efficiency of new targets and new drugs through biological data mining and analysis, simulation and calculation, and shorten the R&D cycle and reduce R&D costs in the construction of laboratory animal models, drug design, pharmacology and pharmacodynamics research, clinical trials, data and other links. Therefore, from biomedical R&D design to clinical data collection, the flexible use of new digital technologies (such as AI, big data, platforms and other technologies) to further improve the success rate of drug R&D and shorten the drug R&D cycle will become an important breakthrough point in the field of biomedical R&D.
2.2. Ensure continuous and stable product quality.
Product quality is the lifeblood of biomedicine. The implementation of quality management and risk control throughout the life cycle of drug R&D, production and circulation is an important part of accelerating industrial upgrading with intelligent manufacturing. In December 2021, the National Medical Products Administration and other 8 departments jointly issued the "14th Five-Year Plan for National Drug Safety and Promoting High-quality Development", which proposed to implement the whole-process supervision of drug safety and continue to promote the construction of a standard system. The construction of intelligent factory is to use digital software and automation system to continuously improve and improve the production quality management system and pharmacovigilance system, create advanced standards for quality traceability informatization in the production process, accelerate the informatization construction of production execution system, data acquisition and monitoring system, laboratory management system, quality management system and big data platform, build a modular, transparent and intelligent production quality process control process, improve the quality management level in multiple dimensions, and fully implement the main responsibility of product quality. Strictly control product quality and provide safe and high-quality biomedical products for the society.
2.3. Continuously improve the level of cost reduction and efficiency increase.
Reducing costs, improving efficiency, and creating growth are important value manifestations of intelligent transformation. Biopharmaceutical companies can use digital tools to achieve a more reasonable synergy between demand and supply and improve the overall efficiency of business operations through process changes in the first-chain business. Intelligent transformation is not only about improving the efficiency and capabilities of drug discovery, design, and development, but also about opening up new markets and adopting new business models in the field of digital health. Therefore, through AI intelligent technology, we can strengthen the management of the best chain and customer relationships, open up the business process information island, enable the rapid flow of information between departments, and enterprises can use digital tools to reshape the customer experience, actively respond to the diverse needs of business scenarios, and capture new business growth opportunities. By summarizing, optimizing and solidifying personal experience, we can reduce the dependence on personal experience and realize the systematization, corporatization and inheritance of personal experience. Combined with the powerful functions of the enterprise resource planning (ERP) system, the overall planning of material requirements planning according to the production plan can be realized, so as to optimize resource allocation, reduce capital occupation, improve inventory turnover rate, and reduce production costs.
3. The trend and direction of the intelligent transformation of the biomedical industry
The biomedical industry is a strategic emerging industry related to the national economy and people's livelihood, and it is of great significance to strengthen basic research and scientific and technological innovation capacity building, seize the opportunity of intelligent development, and promote the high-quality development of China's biomedical industry, which is of great significance to improving people's livelihood and well-being, realizing Chinese-style modernization, and jointly building a community of health for mankind.
3.1. Open up new fields and promote the extension of the biomedical industry to the high-end direction
The deep integration and self-iteration of biotechnology and information technology have introduced a new paradigm to promote the technological progress of the biomedical industry. It is necessary to promote multidisciplinary cross-collaborative public relations with computational medicine as a new tool for drug research and development, and rely on artificial intelligence technology, biomedical and health big data resources to develop intelligent decision-making knowledge models and algorithms to assist in the research and development of personalized new drugs. Vigorously develop new technologies such as information technology, spatial structure analysis technology, molecular simulation technology, machine learning technology, cloud computing, and blockchain in biomedical manufacturing, and introduce new paradigms for innovative research and development through free energy computing, stereochemical analysis, molecular docking, and deep learning, and enhance independent design and source innovation capabilities in the research and development of new vaccines and innovative drugs. Using cutting-edge technologies such as 5G, blockchain, and the Internet of Things to realize the full life cycle management of drugs and vaccines from production to use, we strive to build a benchmark for a digital, high-end, and intelligent biomedical industry chain, and realize the intelligence and digitization of the whole chain of project R&D, production, management, and sales.
3.2. Cultivate new momentum and promote the development of the biomedical industry in the direction of synergy
As the division of labor in the biomedical industry becomes more and more specialized, all links in the industrial chain begin to disperse to different organizations. Due to the characteristics of the biomedical industry with a long R&D cycle, large risks and rapid changes, the industry has promoted the development of the industry in the direction of networked collaboration, and a wide range of dynamic allocation of resources between organizations on demand, upstream and downstream transactions in the industrial chain, service and collaboration have become an important way of industrial management, and the marginal fuzziness of the organization between biomedical enterprises in the same industrial chain will greatly improve the R&D and production efficiency of related enterprises, thereby increasing the competitiveness of the industrial chain. Therefore, it is necessary to seize the opportunity of the digital and intelligent transformation of China's biomedical industry, deeply implement the project of supplementing and strengthening the chain, focus on the shortcomings and weaknesses of key links in the industrial chain, carry out collaborative research and integrated verification of the industrial chain, and promote the popularization, application and iterative upgrading of biomedical achievements.
3.3. Build new advantages and promote the biomedical industry to move forward in the direction of intelligence
Based on the digitalization of quality tracking in the whole process of production and manufacturing, we will vigorously develop biomedical intelligent equipment and intelligent factories to ensure that the production process is fully recorded and controllable, and the production process is automated, transparent, lean and closed-loop integration. Further enhance the original application ability of digital technology in the field of biomedicine, based on the whole process of traceability, electronic information, process visualization, comprehensive supervision, open platform and convenient use, promote the efficient coordination of the industrial chain, accelerate the construction of information technology such as production execution system, data collection and monitoring system, laboratory management system, quality management system and big data platform, implement quality management and risk control throughout the life cycle of drug research and development, production and circulation, and fully implement the main responsibility for product quality. Strictly control product quality, provide safe and high-quality products for the majority of patients, and shape an innovative ecosystem for biomedical intelligent manufacturing. (Author: Zhang Shuping).
The institute originated from industrial competitive intelligence monitoring, developed and grew in industrial planning consulting, and became famous in the national new city and new area planning whole chain consulting. Focus on big data, consulting, planning, design, investment promotion, operation and hosting of industries and industrial parks.