Recently, as cell and gene therapies have begun to emerge in the life sciences manufacturing landscape, an important concept has begun to draw attention: traceability. However, it is important to remember that traceability was critical long before today’s most cutting-edge therapies began development. Traceability has been essential in the manufacture of nearly every treatment, both in process definition and in product data, lest those steps become an impediment to speed-to-market.
Emerson’s Bob Lenich and Michalle Adkins explored the importance of traditional traceability in a recent article in Pharmaceutical Manufacturing magazine. As Bob and Michalle explain, throughout the development pipeline, teams will need to look back on previous steps to help them validate what happened, and what to do next. If they cannot easily trace the process backwards, development will be delayed.
Following what happened
Bob and Michalle explain that tracing the master recipe for a therapy is a critical element of successful manufacturing. As a treatment passes through many stages of development, it will undergo changes that impact the master recipe. To have an accurate master recipe at the end of development, teams need to ensure they have kept accurate records of which versions of a recipe were used at every stage in the pipeline.
But teams need to know more than just what changes were made to the recipe, they also need to know what happened. Bob and Michalle explain,
“It is also critically important that organizations can clearly, quickly and comprehensively trace what happened in each production batch across each development stage, including all findings. These include what worked and what didn’t, as well as feedback on what happened. All recipe elements — process sequence, materials, equipment, sampling and testing, etc. — contain key data needed for both formal records and troubleshooting problems.”
But tracing all these stages is difficult when at every step of the pipeline different teams use different tools and store data in a variety of formats and locations.
One tool to unlock traceability
Bob and Michalle stress the importance of using a single digital tool to improve collaboration and standardization across the treatment development pipeline. One of the most popular tools for this purpose has been Process and Knowledge Management (PKM™) software. With PKM, Bob and Michalle explain,
“every stage of the production pipeline uses the same web-based electronic tools to define the process recipe and to standardize manufacturing objects and data, improving accessibility and collaboration. Any authorized user can more easily create, locate, share and comprehend a therapy’s manufacturing specification data using fit-for-purpose generation and discovery tools at any stage in a product’s life cycle.”
And the best PKM software can seamlessly integrate into a company’s enterprise resource planning software for even better tracking and traceability.
Bob and Michalle go into much more detail surrounding software and technologies to help teams manage traceability across the entire drug development pipeline in their full article. Read it to learn more about how tools like the manufacturing execution system and digital manufacturing operations management all work together to create a single source of truth to make it easier to successfully trace a treatment across all manufacturing steps.
