Cutting-Edge DMS Emphasizes Data Contextualization for Pharmaceutical Organization

Project Summary:

The objective of this project was to develop the Automation Infrastructure and Data Management System backbone for the world’s largest Cell and Gene Therapy Pharmaceutical (CDMO). Center for Breakthrough Medicines’ (CBM) primary aim was to automate data collection and contextualization while ensuring logical controls are in place to protect client data and proprietary information. The system will provide a platform for equipment deployment and integration, maximizes flexibility and redundancy while minimizing upkeep and maintenance, and incorporates cutting-edge automation and IT technology for expansion and future growth.

Problem:

Development of the automation backbone is essential for efficient management of data, which, in turn, is crucial for business and organizational success across industries. CBM’s goal was to develop a robust Data Management System (DMS) and automation infrastructure to provide time-series and relational data archives as well as deploy process control capabilities for future needs.

The primary objective of the project was to automate data collection and contextualization as much as possible and make data readily available to all end users, including clients, enabling scientists to focus on science and business developers to focus on business development by eliminating manual data collection activities. In line with this objective, the DMS aims to ensure logical controls are in place to protect client data and proprietary information while still providing a high-availability interface.

Solution:

To facilitate quick and easy equipment deployment and integration, the system provides a platform from both functional and validation perspectives. The system's flexibility and redundancy are maximized while minimizing system upkeep and maintenance to ensure maximum efficiency.

The DMS is designed utilizing cutting-edge automation open-source technologies, including Opto 22 hardware, Inductive Automation’s Ignition SCADA platform, Canary Historian, and utilizing MQTT protocol, providing CBM with the tools and platforms for expansion and future growth. This architecture was designed with scalability in mind, ensuring that it can accommodate the growing needs of CBM as the company expands not just site-wide, but globally. The system's capabilities also allow CBM to collect, record, and distribute data more efficiently, reducing the potential for human error and freeing up scientists to focus on higher-level analysis and scientific research. By incorporating all data repository and collection systems under one global strategy based on their data model, CBM has a streamlined approach to data management, enabling efficient and effective data analysis, quicker decision-making, and minimizing the effort of system expansion.

To ensure that the system is accessible to all end users, the DMS is designed to provide a high-availability interface, enabling all authorized personnel to access data readily. The system also features logical controls to protect client data and proprietary information, reducing the risk of data breaches and ensuring that CBM remains compliant with regulatory requirements. Utilizing these logical controls, a client portal has been incorporated into the DMS using Ignition to enable clients to securely access their data and reports in real time. The client portal is independent of the core DMS infrastructure, ensuring both cyber and data security as well as data integrity. This level of client access is unprecedented in the CDMO space.

The DMS also provides CBM with a platform to streamline equipment deployment and integration, reducing the time and resources required for installation and setup. By maximizing system flexibility and redundancy while minimizing system upkeep and maintenance, the DMS enables CBM to allocate its resources more efficiently and focus on core business activities. CBM has estimated the use of MQTT and Sparkplug B, in conjunction with Opto22 groov EPICs, Ignition, and Canary, has reduced tag deployment and verification efforts by 95%. Additionally, the use of MQTT enables CBM to contextualize data and add required metadata at the source of generation, thereby eliminating the need for a data lake, as batch records can be extracted utilizing the raw data directly.

Result:

This approach to development of automation infrastructure and data management, the development of a robust architecture utilizing open-source technologies, incorporating data repositories, and collection systems, has been instrumental in enhancing data management efficiency, data analysis, EBR development, and decision-making process for CBM based on its data model. The system's automation, scalability, flexibility, and redundancy, combined with the high-availability interface, logical controls, and equipment deployment platform, ensures CBM can operate efficiently, expand rapidly, and meet the demands of a rapidly evolving industry. CBM’s DMS architecture and automation infrastructure are the most advanced in the pharmaceutical industry, enabling CBM to provide more services and data availability to its clients and giving it a major advantage over its competitors.

Deploy Date: August 2022