There exists an interesting tension in the life sciences industry; while people have access to more treatments for more maladies than at any other time in human history, there is also increasing pressure to deliver new, innovative treatments. For evidence, simply look to the massive wave of innovation happening in the personalized medicine space. The public knows we’re in a golden age of innovation, and their expectations are high.
To meet these needs, manufacturers are moving away from designing plants that focus on a single, blockbuster drug, instead opting for more flexibility in the way they operate. But flexibility does not come easily. Nor does operational efficiency, which is critical both to staying profitable, and to meeting increasing regulatory requirements surrounding sustainability.
Ultimately, as Michalle Adkins and Drew Mackley explain in their recent article in Pharma Manufacturing, the solution comes down to data: how we handle it, and how we maintain its context across multiple competencies.
“With effective data management grounded in data accessibility, contextualization, and traceability sourced from a boundless automation vision, life sciences teams can unlock faster, easier technology transfer and operational sustainability. Meeting those goals will help get treatments into the hands of patients around the globe as quickly as possible.”
Early stage success
As teams explore how they will manufacture a new treatment in the process development and clinical manufacturing stages, they generate loads of data.
“Throughout the many experiments they perform, team members need to understand what version of the process is current at any given time. They need clear visibility into the order of unit operations, as well as the parameters for a given experiment. That is a lot of data to track by itself, but the issue is compounded by the fact that data is not used in isolation.”
Successfully navigating these challenges means having a tool for data management and collaboration across multiple functional areas. Emerson’s DeltaV™ Process Knowledge Management (PKM) software is a critical tool for standardizing processes and increasing flexibility. Michalle and Drew explain,
“Using PKM software, development teams gain access to centralized recipe translation and management to create a single source of truth for fast, accurate information sharing. PKM software facilitates the standardization and communication of product definition, specification structures, and process terminology throughout the product lifecycle.”
Simulation for success
As a treatment moves to commercial manufacturing, scale up and scale out further complicate the technology transfer process. Teams will need to ensure that the facilities where they plan to produce treatments are up to the task, and are located in the right regions to serve critical populations. Simulation technologies, such as Emerson’s DeltaV Mimic provide the tools teams need to test procedures, and/or to design greenfield manufacturing plants that fit organizational requirements.
Teams can also leverage the benefits of DeltaV PKM in this stage as well.
“PKM solutions include facility fit tools that use the data gathered in previous development phases to identify whether a given site has the right quantity and type of equipment with the appropriate capacity to meet production goals. The best tools can get very specific—identifying specific needs or shortcomings, such as having the right number of chromatography columns or a requirement for a vessel with a jacket—alerting users when manufacturing configurations do not meet their needs.”
Reliability is key
Accurate, effective, efficient processes are at the heart of good life sciences manufacturing, but success does not end with great process design. As operations are running, organizations will need to know that their assets are running reliably 24×7, both to ensure continuous manufacturing capability and to meet regulatory requirements. Teams must monitor devices, assets HVAC systems, and more to ensure they run at peak performance.
Modern wireless vibration sensors like the AMS Wireless Vibration Monitor and AMS Asset Monitor are critical tools for keeping tabs on balance of plant equipment. These sensors continuously collect raw vibration data and deliver it to the reliability team as an intuitive asset health score so plant personnel can quickly identify which assets need attention.
Moreover, information from sensing technologies can be tied into a comprehensive machinery health software solution like AMS Machine Works, or even an enterprise-level, AI-based analytics solution like AMS Optics. Leveraging these powerful software packages, teams receive instant decision support to drive more autonomous, reliable operation.
