(1) BioLeague's Bio-AP microservice platform ---- strategic plan to build a digital ecosystem for precision medicine and innovative biologics R&D
01/ Digitalization in the life sciences industry - the theme of future development
As we all know, digital transformation is the core concept of Industry 4.0, and end-to-end integration is an important core content of Industry 4.0 strategy. In the language understood by the life sciences industry, end-to-end integration is the digital management of the entire life cycle of biopharmaceutical preclinical R&D, IND, NDA, marketing and sales, which means that higher requirements are put forward for digital systems and IT infrastructure.
The 2nd edition of the GAMP5 guide to incorporate new and evolving topics in the life sciences industry, such as blockchain, artificial intelligence/machine learning (AI/ML), cloud computing, and open source software (OSS), speaks volumes about the new technologies, including cloud computing, that are being embraced by the life sciences industry.
Bio-AP Microservice Platform: Focusing on gene and biotechnology, providing smart laboratories and intelligent manufacturing solutions, including Bio-LIMS© smart laboratory information management system, Bio-Research© R&D laboratory management system, Bio-CELL© cell and gene therapy data integration information platform system, Bio-Vaccine© innovative biologics production data integration information platform system, It covers the whole life cycle process from scientific research to production. Biolimon's Bio-AP microservices platform provides solutions that are fully compliant with regulations and norms in the life sciences industry:
● At the basic regulatory level, it complies with 21 CFR Part 11 (Electronic Records and Electronic Signature Regulations), ALCOA+CCEA Principles (Data Integrity Principle) and the Electronic Signature Law of the People's Republic of China;
● At the level of laboratory specifications, it meets the requirements of GLP (Good Laboratory Practice), ISO17025 (Laboratory Certification for Testing and Calibration), ISO15189 (Medical Laboratory Certification), CAP/CLIA (American Society of Pathologists Laboratory System Certification) and other relevant regulations for computerized systems;
● At the level of GMP specifications, it complies with ISPE GAMP5, NMPA "Computerized System", NMPA "Drug Record and Data Management Practice", NMPA "Biological Products", NMPA "Cell Therapy Product Manufacturing Quality Management Guidelines (Trial)" and relevant regulations and norms of FDA and the European Union.
BioTechLeague | Build a digital ecosystem for precision medicine and biopharmaceutical R&D
02/ Alibaba Cloud Box Software and hardware integration - local deployment of public cloud
In 2022, Biolim and Alibaba Cloud Cloudbox reached an in-depth cooperation to jointly release the "Digital Joint Solution for Precision Medicine and Innovative Biopharmaceuticals on the Cloud" by integrating the advantages of both parties, realizing the localized deployment of BioLeague's Bio-LIMS© smart laboratory information management system, Bio-Research© R&D laboratory management system and other information systems in the field of biotechnology. Third-party medical testing laboratories, gene and biotechnology technology companies and other enterprises create a one-stop service for the whole life cycle from scientific research to production.
As a public cloud localization deployment service that integrates software and hardware, Alibaba Cloud Cloud Box provides users with product capabilities and user experience consistent with public clouds, meeting the needs of local deployment of customer data, nearby processing of massive data, and low business latency.
In other words, a set of cabinets such as CloudBox allows users to bring back a cloud of Alibaba Cloud and quickly deploy it where customers need computing power.
Based on Alibaba Cloud's rich industry experience in the field of life sciences, the alliance between Alibaba Cloud and Biolimon combines the advantages of Alibaba Cloud Cloudbox's on-site computing power, cloud-native PaaS product capabilities, multi-active disaster recovery, and O&M-free to realize the localized deployment of Biolimon's precision medicine and innovative biopharmaceutical digital solutions, with four advantages: security compliance, interconnection, unified management of multiple branches, and flexible expansion.
Biolimon & Alibaba Cloud | Build digital solutions for precision medicine and innovative biopharmaceuticals on the cloud
Biolimon's digital system for precision medicine and innovative biopharmaceuticals based on cloud-native architecture can be deployed at any designated location of the customer to realize the data localization of SaaS applications in the life sciences industry and meet the data security compliance requirements of life science enterprises.
Vertically, the integration of online digital management and offline "R&D + production + quality control + operation business management + traceability" is realized; Horizontally, it helps enterprises achieve seamless connection with existing enterprise businesses, and creates an integrated digital platform for cloud-edge collaboration.
For the model of one center and multiple branches of precision medicine laboratories, such as the multi-center scenario of "R&D, production, and operation" of innovative biological drugs, the unified entrance, unified planning, and unified control of the system can be realized. At the same time, it can also reduce the investment of operation and maintenance labor costs while reducing TCO.
The joint solution supports a subscription payment model, and the lightweight output can save costs for start-up life science enterprises. At the same time, Alibaba Cloud Box can flexibly expand to hundreds of nodes, facilitate the rapid digital construction coverage and business operation in other regions in the future, and meet the business expansion needs of large life science enterprises.
On the other hand, Biolimon has completed the integration of its applications with the cloud through Alibaba Cloud Nest to help customers build digital solutions for precision medicine and innovative biopharmaceuticals on the cloud with one click, simplifying the complexity of cluster deployment. Compared with the traditional delivery cycle in days or even weeks, the delivery efficiency has been greatly improved.
With the strong cooperation between Alibaba Cloud and Biolimon, Biolimon will be able to further maximize performance, better integrate software with the cloud, greatly improve the efficiency and user experience of software services in delivery, deployment, and follow-up management, and take a step forward on the road of helping users reduce costs and increase efficiency. At the same time, Biolimon has joined the Digital Intelligence CRO Ecological Alliance established by Alibaba Cloud's medical industry line, and the two parties jointly help CRO companies digitize and online service resources and process management.
In the future, Alibaba Cloud will carry out continuous, long-term and in-depth cooperation with Biolimeng at more levels, and deeply integrate Biolimon's multiple biotechnology information systems with Alibaba Cloud Cloud Box as the technical base, so as to help large-scale research hospitals, national laboratories and research institutes in the field of life science and medicine, third-party medical testing laboratories and other industry institutions improve the level of informatization and intelligence in an all-round way, and provide a path for continuous innovation in future medical construction.
(2) Bio-AP microservice platform---- lightweight, completeness, flexibility, and speed
Bio-AP Microservice Platform | Lightweight & Complete&Flexible & Fast
It can be seen from the relevant reports in 2021 that at present, enterprises generally pay attention to "information security-related construction, business process reshaping and sorting, marketing management innovation in response to business changes, and infrastructure optimization", and focus on "digital middle platform, RPA, AI blockchain technology, and innovation mechanism establishment" are ranked behind.
"Ensuring compliance, reducing compliance costs, realizing data and information traceability, realizing data integration and interconnection, and solving information silos" is still the current status quo of life science enterprises, and more enterprises are still in the process of transforming from paper-based office to digital office to solve the above problems.
From the perspective of the international environment, many enterprises have introduced cloud services, machine learning, and deep learning (such as R&D cloud service software applications). Machine learning has been widely used in quality management, laboratory management, R&D and production management, etc., such as active experiments, intelligent management of production quality, active intelligent scheduling, intelligent decision-making analysis of operational data, data predictive substitution of past tense, classification and prediction of various information of R&D experiments and production, etc., and it is believed that China will gradually move towards this trend.
After more than 10 years of continuous innovation and exploration, Biolimon has formed a Bio-AP microservice platform that is professionally suitable for laboratory digital services and biopharmaceutical life cycle digital services---- which can be modularly built and assembled according to the actual needs and development stages of different customers. For various hierarchical systems such as the traditional architecture device, cloud service, and decision-making end, it solves the pain points such as low data transmission efficiency and inability to explore data in real time. Industry 4.0 Internet of Things flat digital standards, to achieve different systems can be real-time data exploration, reduce costs, coupled with innovative biological drugs of many types, different processes, fast process upgrades, technology platforms and other practical problems, the need for lightweight systems, functions and modules complete, support flexible configuration and rapid online and implementation of the use of information systems, for research central hospitals, CRO+CDMO, molecular testing, biological drug R&D and production and other enterprise customer services. Help create more tangible enterprise development value.
Especially for some start-up companies, it can be planned in a unified manner, distributed and implemented, and launched by module. For example, in the field of cell and gene therapy, the traceability system that CDE regulations are most concerned about can be launched first, and then the digital modules of production, quality control, and R&D can be launched.
(3) Biolimon's Bio-AP microservice platform AIGC model
From informatization, digitalization to artificial intelligence & from cloud to industry-customized LLM models
AIGC Model | From general to in-depth customization of industry AIGC models
In view of the general trend of the development of the life sciences industry, the current life science industry has reached the stage of "going deep into the microenvironment of genes and cells, breaking through the bottleneck of detection and new drug research and development", and the digital transformation of life sciences has been elevated to the level of national strategic development and the trend of global supervision. The core goal of BioliM's Bio-AP microservice assembly platform is to provide end-to-end digital solutions for the global biopharmaceutical and precision medicine industries.
In addition to the on-premise implementation, Biolim is also exploring how to use the cloud more widely while being compliant. Jointly build a cloud-based precision medicine and innovative biologics information management platform with Alibaba Cloud, tailoring customer solutions for start-up molecular diagnostic enterprises and biological research teams, innovative biologics R&D and production, cell and gene therapy and tumor personalized vaccine R&D and production-oriented enterprises. Cloud services provide large storage, large computing power and scalability support, making it possible to realize large models from information systems to big data, artificial intelligence, and even industry LLMs.
Regarding the current hot large model, the human intention that ChatGPT can achieve comes from the accumulation of multiple technologies such as machine learning, neural networks, and reinforcement learning models, which is a process from quantitative change to qualitative change. The information system generates big data of experiment, production, and quality, and can use machine learning for predictive analysis, and has now progressed to the stage of deepening the LLM large model in the industry.
At present, life science enterprises can use the LLM large model to improve work efficiency, and Biolimon's digital system is also integrating with the LLM large model API to achieve intelligent communication, training interaction, information prompting, data retrieval and other functions. From the general LLM model to the industry-specific LLM model, it is a process of reinforcement learning, a process of repeated training, modeling, and feedback.
(4) Bio-AP micro-service platform
Digital Transformation in Life Sciences--- Value to Customers & Social Benefits & Economic Benefits
At present, BioliM's Bio-AP microservice platform has served the daily management work in the global market (China, the United States, and the Middle East), especially in the Beijing-Tianjin-Wing and Pearl River Delta regions in China.
For example, BioLeague's customer Xingyiang (focusing on the R&D and industrialization of immune cell drugs, and developing allogeneic generic spot immune cell products), cell drugs start from the source stage of R&D, and the digital management of the whole life cycle of IND, NDA, production and operation is the trend of future development.© It solves these core pain points, such as: standardized execution and paperless management of laboratory data, inheritance of valuable technology & experience, data security and knowledge protection, project progress & cost monitoring and management, rapid extraction, analysis and traceability of key value data information, etc.
The core value of Bio-CELL© cell and gene therapy data integration information platform is to realize the computerized system management of the whole process of cell production business of Shanghai Pharmaceutical Biology, record and analyze the whole life cycle of products, ensure the safety, controllability and traceability of products, ensure product quality, and realize CoC (chain of custody) and CoI (chain of identity) of products.
BioTechLeague | Value to customers & social benefits & economic benefits
Biolim released the "Digital Joint Solution for Precision Medicine and Innovative Biologics on the Cloud", which will further maximize the performance, better integrate the software with the cloud, greatly improve the efficiency and user experience of software services in delivery, deployment and follow-up management, and take a step forward in helping users reduce costs and increase efficiency. We will continue to develop, iterate, explore and innovate, create more possibilities for cutting-edge technologies in the industry, and aim to provide our customers with intelligent, safe, compliant, and diversified one-stop solutions for the whole process, promote industrial development, and see future business opportunities.