As biopharma manufacturing shifts from pre-digital processes to more digital ones, technology providers will develop intensified bioprocessing technologies together with software, automation, and analytics to help advance the industry through its digital transformation. MilliporeSigma is collaborating with manufacturers to provide software solutions that help the industry gain the greatest benefit from advanced bioprocessing technologies. Among these solutions is the Bio4C™ Software Suite — standalone but compatible software products that enable enhanced process control, better use of data, and improved decision making with near real-time data analytics. Part of the Bio4C™ Suite is Bio4C™ Orchestrator, a centralized “orchestration layer” that connects to individual unit operations for complete visibility, monitoring, and management of regulatory-compliant biomanufacturing systems and processes. 

The Digital Plant Maturity Model

According to the BioPhorum’s  digital plant maturity model (DPPM), there is a series of evolutionary stages through which biopharmaceutical manufacturing companies pass as they integrate more digital systems into their organization’s plant. DPMM’s first level is the traditional, pre-digital plant, which relies primarily on paper-based and manual processes.

At the second level, some automation and digitalization of individual skids or unit operations have been implemented, but these systems exist as “islands of automation”. Analytics are on-demand with mostly manual data centralization. At the third level, digital silos are now connected, with different systems communicating with one another. At the fourth level, there are integrated, real-time, predictive analytics, advanced production monitoring, and online/at-line quality testing. The fifth and final level is an aspirational future state of a fully continuous, adaptive and autonomous plant.

Most biopharma companies today have reached the second level of maturity — they have implemented some automation and online or at-line process and data analytics and are working toward having their systems fully communicate with one another.

Bioprocessing Challenges

Typical bioprocesses, from the start of upstream operations to the completion of the fill-finish step, may take a month or more to complete. Through all process steps, monitoring of critical process parameters is essential to ensure optimal process performance and product quality. Using automation and digitalization to achieve remote process monitoring enables optimization of workflows and addresses industry challenges around reducing manual tasks, human errors, and operating costs.

Bringing Bioprocessing Companies into the Digital Age with Process Orchestration

MilliporeSigma conducted an extensive market survey and learned from customers about their present-day obstacles and goals down the road. Bio4C™ Orchestrator Software is designed with a scalable and modular architecture to solve biopharma manufacturers’ current challenges and to meet their future requirements. Customers can select the features that they currently need and then add additional modules as their digital transformation proceeds.

Bio4C™ Orchestrator is a flexible and easily deployable process orchestration solution, which enables remote monitoring of unit operations and automation of manual tasks. The software connects to skids from a centralized “orchestration layer” for complete visibility and management of regulatory-compliant biomanufacturing systems and processes.

Bio4C™ Orchestrator’s browser-based user interface and HTTPS protocol allow highly secure data access for an unlimited number of users without the need to install software on a laptop. Through a secure connection to their organization’s intranet, approved users can log into Bio4C™ Orchestrator from a browser window and remotely monitor systems, recipes, reports, user accounts, and alarms.

The software is intuitive and does not require extensive training. Designed with the nature of the application and the user’s bioprocessing expertise in mind, the software mirrors workflows and sequences found in bioprocess manufacturing to make the introduction of automation straightforward.

The benefits of moving from manual, isolated processes to centralized, digital workflows can be demonstrated in a user and password management use case. With manual workflows, to add users, assign or change roles, and manage passwords, a supervisor must access multiple skids across a large manufacturing floor. Consider, for example, a supervisor who is responsible for 10 operators who use six unit operations. This translates into our supervisor logging into six different HMIs and creating 10 new user and password combinations (or  6  10 or 60 user creations) and when the various roles are also considered — let’s say four different roles for each user created — then across these six skids for our 10 operators creating four roles (or 6  10  4) — there are 240 manual tasks.

Now consider Bio4C™ Orchestrator’s centralized User Management menu.  From here, an administrator can add or remove users, assign and unassign user roles, and grant access to unit operations. All these changes and updates take effect across multiple remote skids with a single edit from the User Management dashboard. The manual work of an hour or more — moving from skid to skid, logging into various HMIs — is accomplished from a single browser window in minutes.

Similar efficiencies with data gathering and reporting can also be gained through Bio4C™ Orchestrator’s centralized Report Management menu. Rather than logging into each separate HMI, saving files to individual PCs connected to a unit operation, and finally collating multiple reports into a single report, a user can generate and customize reports consolidated from multiple skids with just a few clicks from Bio4C™ Orchestrator’s Report Management dashboard.  

Centralized orchestration provides remote monitoring and visualization of bioprocessing systems, recipes, reports, user accounts, and alarms and reduces manual tasks, human errors, and operating costs while improving productivity and product quality. As the biopharma manufacturing industry progresses in its digital transformation, orchestration software that automates entire workflows will become a strategic part of its digital evolution. As an orchestration platform purpose-built for biopharmaceutical manufacturing — rather than software retrofitted for use in another industry — Bio4C™ Orchestrator is ideally positioned to help manufacturers significantly advance their facilities to the next stage of the DPPM.

Reference

1. Bio4C™ Orchestrator Software Data Integrity Assessment. Apr. 2021.