In the last few years, life sciences innovation has jumped by leaps and bounds. Many of the emerging autologous, patient-specific therapies being released are accomplishing things the general public never thought would be possible.
These autologous treatments are highly technology dependent. They require flexible manufacturing and push as close to real-time release as possible. But, as Christian Berg explores in his recent article in Pharmaceutical Processing World, such capabilities need not be limited to cutting-edge autologous therapies,
“The operational integrity, flexible manufacturing, and real-time release lessons biopharmaceutical companies have learned from the development of autologous therapies can be effectively applied to other life sciences products—as the required tasks for these products can be extremely labor intensive when manufactured using traditional process control strategies. Applying lessons learned from the high-paced, high-criticality, distributed manufacturing world of autologous cell therapy effectively means leveraging the same born-digital, connected software ecosystem that is key to driving speed and efficiency in other areas.”
Improving traceability
Many of today’s newest treatments have increasingly strict traceability requirements. Accomplishing that goal means aggregating information from many different sources while maintaining data integrity and facilitating technology transfer. Today, such tasks are nearly impossible to complete manually. As Christian explains,
“That is where automation software designed as part of a connected ecosystem can drive success.”
The manufacturing execution system (MES) and distributed control system (DCS) are critical elements of managing traceability. When the software is seamlessly integrated, as it is between the DeltaV™ MES and the DeltaV DCS, it is far easier for teams to ensure data is correct at every stage—from development through to full-scale manufacturing.
Optimizing operations
Once a therapy is being consistently produced, teams can deploy other software solutions to increase operational efficiency. DeltaV Real-Time Scheduling (RTS) uses predictive modeling coupled with process data to generate schedules and ensure well planned and executed operations.
“Along with other benefits, RTS software can both visualize constraints and predict the impact of batch timing changes to help teams maintain flexibility and adjust to changes without disruption.”
Another software solution helping teams standardize operation and increase flexibility is DeltaV Process Knowledge Management (PKM). PKM software replaces manual methods with a structured repository and collaborative platform to drive global collaboration, efficient recipe scaling, and seamless integration with existing systems. Christian explains,
“PKM provides a central data repository where process specifications are defined digitally, facilitating collaboration, and simplifying the technology transfer process for manufacturing.”
Translating value
Not every organization is equipped to delve into the world of personalized medicine. However, the lessons we can learn from the born-digital expertise demonstrated in that area of the life sciences industry are applicable to life sciences manufacturers in every area. By first taking advantage of the software solutions designed to increase flexibility and operational excellence, and then using those tools to build out a seamlessly integrated infrastructure designed around a Boundless Automation vision for seamless data mobility, teams can eliminate complexity from their operations and start moving toward a semi-autonomous, real-time release model. Doing so will help organizations secure competitive advantage and bring lifesaving and life-improving treatments to patients in record time.
