The gains for bioprocessing by going through the digital transformation process are better yields and lower costs to production operations. For example, improved technologies could assist with reduced maintenance downtime and better control of spare part inventories for industrial process equipment. These factors could contribute to continuous improvement initiatives and better process robustness. A bioprocess is a specific process that uses complete living cells or their components (such as bacteria, enzymes, chloroplasts) to obtain desired pharmaceutical products.
The benefits of digital technologies are laid out by Per Lidén from GE Healthcare Life Sciences in an article for Pharmaceutical Online. The key benefits of new technologies, he states, is to liberate data. The main tools for this are open systems leveraging standards for interoperability and data exchange, such as open platform communications.
With open systems, designed for leveraging standards for interoperability, an example is with OpenHIE which is a platform for enabling large scale health information interoperability and providing available standards-based approaches and reference technologies. Such platforms also provide service directories to register ecosystem applications, manage service of record, and exchange service endpoint and transport configuration. In addition they act as object registries that maintain identifier mappings between internal application identifiers and canonical identifiers, which are used as part of standard information models.
With data exchange, such as open platform communications, these are platforms of standards and specifications designed for industrial telecommunication. The platform specifies the communication of real-time plant data between control devices from different manufacturers.
In terms of the benefits for bioprocessing, benefits include improved uptime, especially when equipment is connected since this allows better visibility into the condition of the equipment. This means that an engineer does not need to wait for an item to break; instead preventative actions can be taken in advance.
A second benefit is with improved process understanding. Platforms like manufacturing execution systems and laboratory information management systems, allow for better batch-to-batch traceability. A third area is with robustness and productivity, with data used to iron out sources of variability in manufacturing processes.
The final area is with compliance, ensuing data integrity, in terms of reliability and security. To make all of this work, data flows need to be visualized; teams need to become better connected (helping to effectively manage change within an organization); and the collected data needs to be reviewed and analyzed.
