In the wake of the COVID-19 pandemic and the associated development of a vaccine in record time, the biopharmaceutical industry has seen significant change. Today, we know that faster development is possible, though it is still challenging. That has increased the drive of many organizations to improve speed to market, looking at ways to leverage digital solutions to eliminate wasted time and effort in order to streamline development and manufacturing.
In a recent article in Pharma Manufacturing, Emerson’s Bob Lenich explores this trend, considering how data silos and slow technology transfer create barriers to rapid development, and then exploring how modern technologies can help eliminate those roadblocks.
Beyond electronic notes
One area where organizations have done quite well in moving toward digital operations is with the implementation of electronic lab notebooks (and similar solutions) to eliminate paper records. Today, organizations typically capture data and process/material/equipment specification decisions much more quickly and with far less human error. It’s a great start, but it’s just that—a start. Bob explains,
“Digital transformation that ends with an ELN conversion still creates digital silos. ELN software provides a very efficient way to capture unstructured data and retain it for long-term use, but it is often much less capable in making that data easily available further into the development process. But when that type of environment is put in place, teams can take the next steps to begin extracting data from ELN and other software tools and then put it into a broader digital framework so they can use the information more consistently across the development pipeline and enterprise.”
Moving to the next stage of treatment development will always require the key step of technology transfer—where teams move up in scale. As they do so, they will need to manage and move data with thousands of parameters and map that data to the systems managing the next phase of development.
“Someone must gather all the data and reports from the process development team, carefully comb through the information, extract everything from the destination’s distributed control system (DCS) and manufacturing execution system (MES), and then manually compare parameters, transforming and mapping everything again. All of this must be done under strict change control processes before any manufacturing can begin.”
That process adds months to the timeline of drug development. So, teams are looking for faster solutions. Fortunately, modern software can help break down digital silos and bring data together in a streamlined, standardized format to make it mobile across the entire development process.
Process knowledge management
Emerson’s DeltaV™ Process Knowledge Management (PKM) software is the key to unshackling data for use at every step of drug development. It provides a structured repository for recipe data, making it easy to scale at each stage and integrate seamlessly with new systems. The software captures every decision made in the treatment development process and stores it in a standardized digital repository accessible by anyone with the appropriate rights.
The key advantage of DeltaV PKM is that it eliminates the need for users to collect data from a wide array of systems and manually convert that data to be usable in other software. Moreover, the software manages traceability across the entire process. Histories, logs, and audit trails are all maintained and easily accessible.
Bob also shares that DeltaV PKM now features new transfer hub technology to further simplify the technology transfer process. With transfer hub software, it is far easier to map and convert variables from PKM to other systems like the DCS or MES. Bob explains,
“Teams perform mapping up front, and once they have that map in place, the transfer hub allows future PKM recipes to be converted automatically— instantly ready for operation in the DCS and MES. Instead of mapping every variable every time the team moves to manufacturing, they simply update the newest variables, validate the mappings to ensure nothing else has changed, and use the transfer hub to complete the process.”
Other tools will further speed technology transfer
Of course, these days DeltaV PKM isn’t operating alone. With the rise of AI, even faster technology transfer is just over the horizon. Powerful AI engines can make fast work of mapping content between systems, eliminating the need for users to perform those slow manual tasks, and elevating those personnel to a management role where they confirm the work performed by AI tools.
Ultimately, it’s an exciting time for the life sciences industry. Teams today are already accomplishing speed and traceability that a few short years ago we could only dream about. As software evolves in the coming years, building toward an enterprise operations platform for seamless data mobility, that speed will only increase—delivering capabilities that beggar the imagination.
