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Accelerating pharma potential by driving the “S Curve”

Introducing automation early to accelerate productivity.
Pharmaceutical manufacturers face many challenges to maintaining optimal productivity, yield, and quality from the development stage through to manufacturing and supply. These challenges are growing, especially in biological manufacturing, where batch-to-batch variability can amount to ~40%. In semiconductor manufacturing, maximizing profitability of a new fab can be accomplished using a framework called the “S curve.” (More on this framework can be found here.) We are inspired by the semiconductor industry’s call for increased automation early in development and believe the fundamental benefits of introducing automation early in the pharma S curve can deliver accelerated productivity.

What’s the S Curve?

Figure 1, referred to as the S curve, illustrates a drug life cycle from development to manufacturing and supply. The heavy blue line represents the production goal, while the gray, jagged line represents the ramp that a manufacturer must manage.
S Curve SFRX Fig 1
Figure 1. The “S curve” showing production goal (blue line) vs. production reality (gray line).

Driving the S Curve for Pharma

Pharma manufacturers must optimize quality, yield and productivity (critical factors not shown in Figure 1) to ensure that R&D scale up and tech transfer is seamless and production reality meets or exceeds the production goal. This optimization is called, “driving the S curve.”

The Earlier the Better

The S curve relies on the premise that yield learning and volume production have more value early in the life cycle of a new drug, when it has a higher selling price, than they do later in the life cycle of that same drug. For innovative pharma manufacturers, closing the gap between the blue and gray lines—the unrealized potential—could be worth hundreds of millions if not billions of dollars. As a drug reaches its generic phase, cost pressures dictate that any gains in yield and productivity support a higher bottom line and competitive edge.

Our Recipe for a Successful Drive

Our Applied SmartFactory Rx® suite offers a proven, successful approach for improving quality, yield and productivity to help pharma manufacturers successfully drive the S curve and realize hidden potential. This approach touches on each of the critical stages moving through development to commercial scale manufacturing.

The optimized experimental design platform (OEDP) within our Smart Process Development solution accelerates product development and enables early-stage learnings to be transferred directly into control strategy development. This lays the foundation for confident scale-up to commercial manufacturing. Using Advanced Process Control (APC) and Model Predictive Control, we can manage process variability to optimize yield over time (see Figure 2). Throughout clinical manufacturing, inventory and just in time (JIT) supply can be a significant constraint. Our Smart Scheduling platform has been designed to help address these challenges. To read more about this capability click here.
Figure 2. The benefits of Advanced Process Control for maximizing process stability and raising the operating level toward the upper constraint limit.

Ramp – During this phase, we are aiming to reduce process variation, minimize waste, and optimize a stable yield. This has to be achieved while complying with the high-quality standards of pharma validation criteria.

Key to this approach is deploying software solutions to bring production reality closer to target (see Figure 3). Adaptive scheduling in response to changes on the shop floor, QC labs, and the wider supply chain can increase productivity by enabling the E2E coordination between operations, quality and supply chain. This aims to help pharma manufacturers resolve challenges throughout production, resulting in faster time to market, higher quality and less waste.

Figure 3. The “S curve” showing our approach of deploying proven software automation capabilities to bring production reality closer to target


Today’s pharma manufacturing challenges are difficult regardless of the stage of pharma development or manufacturing and supply timelines you are in. Manufacturers are facing shorter and shorter product life cycles and rapidly eroding margins following many years of development. Whether you need to accelerate the tech transfer of a new process, or enhance the productivity of your installed base, our extensive software capabilities can help you “drive the S curve” to ensure that production reality meets your production goal. In this environment, SmartFactory Rx offers an E2E automation software suite designed for achieving yield, output, and cost improvements at every step of the drug life cycle.

About the Author

Picture of Yoram Barak PhD
Yoram Barak PhD
The SmartFactory Rx Team develops integrated automation solutions for process manufacturing to harness the power of data, reduce development time and improve productivity to optimize high value manufacturing. It increases throughput, decreases risk, and accelerates time to market for new products. For more details, connect with us on LinkedIn.