A pharmaceutical product can start as a research idea, but turning that idea into something that can be created consistently is not an easy path.
Research teams may work with formulation details, compounds, lab results, and lab processes. As development continues the information starts to move into connections with process development, scale-up, manufacturing equipment, materials, quality, and production records.
The key is to keep information needed by these groups together in context.
From Research to Development
Much pharmaceutical research is about exploring options and understanding a potential product and its mechanisms. As an idea moves to development, teams start considering process, test, formula characteristics, material needs and other factors relating to how a company might manufacture a product.
As this environment moves from research into development, more information takes on an operational context. The nature of questions also moves into manufacturing considerations such as:
Can the process be replicated? What materials are needed? What equipment is needed? Which process variables are important? How should the process be scaled?
Moving to Larger Scales
Scale-up is the next challenge. Many lab processes work in the lab, or in pilot batches, but moving to a larger continuous or batch process for commercial manufacturing adds new variables for engineers to consider.
Equipment capabilities, material handling, environmental conditions, procedures, workforce considerations, quality needs, and production records all come into play. There's a large interrelationship of information that comes together to define a successful manufacturing process. Information comes from sources such as equipment involved, materials being used (and their histories), steps taken, environment, quality information, and more.
A single data point rarely tells a complete story.
Where Connected Technologies Come Into Play
Pharmaceutical facilities have many sources of information. IoT and sensor information can bring in information from equipment and the environment. RFID, BLE and other options can add information on assets, materials, or processes. Industrial gateways, edge computing, and other technologies can help tie together these different systems and information sources. This information can be presented with records and other data from enterprise systems such as MES, ERP, LIMS, QMS and more.
The aim is not just about capturing more data.
The intent is about providing context and inter-relationships that make analysis and application simpler and more intuitive.
Keeping Your Manufacturing Story Straight
Imagine a scenario where there was an equipment alert for a manufacturing process.
On its own, this shows what happened (the alert) but not much context on why this occurred. With additional information, a reviewer can relate the alert to a specific manufacturing process and event (batch processing?), materials, equipment history or other connected items. It won't tell you if it impacted your product, that's for a quality assessment. However a connected data source may help provide more context and help teams determine the root cause of this incident.
From the initial research to the records created during manufacturing, each step has information that helps tell the story of how a pharmaceutical product is manufactured. It's up to us to keep this evidence together and connected to give us greater information on our processes.
PharmaFlux AI is an example of a manufacturing intelligence approach focused on connecting information across workforce, assets, inventory, processes, and traceability. The broader concept is to make relationships between operational data easier to understand rather than treating every data source as an isolated record.
Patients need our products and we need to keep building this connected intelligence to ensure our manufacturing processes are well documented understood, and ready to evolve when the need arises.
Innovation → Development → Scale-Up → Manufacturing → Patients
The more we keep these interconnected, the more insight we have on how our pharmaceutical offerings are physically created and managed.
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