Mark-John Bruwer - Senior Director of Product Marketing, Pharma AspenTech
The pharmaceutical industry is on an acceleration path to building greater efficiency and consistency into its production capabilities and it’s not a moment too soon. Multiple elements are converging to both enable and require transformation in the pharmaceutical industry.
The global supply chain impacts of COVID-19 highlighted the urgent need for disruptive technologies to strengthen the agility and resilience of the pharmaceutical value chain network. Fortuitously, in parallel the ISPE's Pharma 4.0 framework and the FDA's Advanced Manufacturing Initiative are promoting the benefits of integrating Industry 4.0 capabilities into the pharmaceutical sector. Together, these factors yield an unprecedented opportunity to improve the reliability, quality and cost efficiency of pharmaceutical product supply when and where patients need it, while also addressing sustainability goals.
This digital transformation, already occurring in other industries like the energy and chemicals sectors, is supported by the following four innovations, among others:
1. Mitigating equipment downtime and over-maintenance through predictive and prescriptive maintenance
Like any industrial organization, pharmaceutical facilities are beset by occasional equipment failures due to stress events or long-term wear and tear. Traditional or preventive maintenance programs are often calendar-based rather than based on need. As a result, organizations waste time and resources on unnecessary maintenance that still does not help avert a potential shutdown.
A step up from calendar-based maintenance is a condition-based approach – typically using vibration and temperature monitors to diagnose when equipment is close to failure and needs immediate attention. However, this is still disruptive to operations because it remains somewhat reactive. By contrast, a predictive and prescriptive maintenance approach uses historical data and machine learning to predict when a piece of equipment is expected to degrade to the point of failure, while identifying the root cause. This enables advance maintenance planning, which facilitates for proactive adjustments to both maintenance and production schedules. With this advanced approach, both safety and product delivery risks are avoided.
2. Ensuring on-time delivery via supply chain management, while supporting sustainability goals
Reliable access to life saving medicines continues to be a top business imperative in the pharmaceutical industry, especially with the unprecedented disruptions and uncertainty we’ve witnessed in recent years. Digital planning and scheduling technologies provide significant support to streamlining production activity and easing supply pressures.
These tools build agility and flexibility into the production schedule by optimally leveraging the available tradeoffs on the use of labor, equipment, materials and energy. The boost in operational intelligence helps production lines effectively respond to shifts in supply and demand as well as unplanned events, balancing nearterm and long-term priorities. Additionally, by enabling improved efficiencies through digital planning and scheduling, there is an inherent offset to waste and CO2 emissions, which supports the sustainability goals many companies have in place.
3. Leveraging modernized process analytical technology to speed production of quality medicines
Out-of-specification product quality, long batch cycle times, suboptimal product yield, and prolonged wait times for laboratory testing are common challenges for pharmaceutical production lines. Together these obstacles impede the ability to produce life-saving medicines with speed and reliability.
The pharmaceutical industry must more widely adopt modernized Process Analytical Technologies (PAT), which can provide easily digestible analytics for identifying the right operating conditions for various production scenarios; support closed-loop control for consistent quality and yield; support the conversion of batch processes to continuous manufacturing; and certify product quality efficiently through real-time release testing. With this extra insight and speed, pharmaceutical production lines can increase throughput, reduce the occurrence of failed batches, and maintain a more consistent baseline of product quality. Together these factors significantly lower the cost of goods sold and speed up the delivery of medicines to market, to meet patient needs.
A great example is from Ferring Pharmaceuticals1, which demonstrated the effectiveness of PAT combined with closed-loop control to shift from batch to continuous manufacturing, netting greater production agility and an anticipated 25% reduction in cost of goods sold.
4. Ensuring equipment flexibility through batch processes
Leveraging PAT to transition batch processes to continuous manufacturing is a key element of pharmaceutical digital transformation. However, batch processes will remain essential to pharmaceutical manufacturing, in no small part because of the need for flexibility in reusing equipment across product lines. To do so effectively, however, requires speed and accuracy from raw materials preparation, through production to product release.
A key enabler for speed and accuracy is the use of tools and database schemes that make it easy to archive, retrieve, and organize data on raw materials, production steps and final product across the organization as needed, avoiding the tedium and errors of manual data transactions wherever possible. The net benefits include reducing batch cycle and product release times together with increasing the accuracy of outcome. This data can also be applied to advanced batch analysis and optimization. By mapping insights and takeaways from past data, pharmaceutical companies can maximize yield and quality, while minimizing batch cycle time for future batch operations — and ensure consistent batch execution across the board.
The Pharma 4.0 framework and the FDA’s Advanced Manufacturing Initiative have helped lay the foundation for a new, digitalized pharmaceutical industry, and COVID-19 has amplified the expectation for safe, affordable and effective medicines delivered quickly to patients. This new era is propelling the pharmaceutical industry to take a focused approach to its digital transformation.
Predictive and prescriptive maintenance, digital supply chain scheduling solutions, process analytical technologies, closed-loop control, and efficient batch execution and release are all key to this industry-wide digitalization journey. They are yielding higher quality pharmaceutical products, more time- and cost-efficient processes, faster time to market and more sustainable production.
References
- Ferring Prototypes Continuous Manufacturing with Advanced PAT and Closed-loop Control, Potential for Dramatically Lower COGS | https://www.aspentech.com/en/ resources/case-studies/ferring-prototypes-continuous-manufacturing-with-advanced-pat-and-closed-loop-contro
Mark-John Bruwer is Sr Director, Product Marketing, Pharma at AspenTech. Mark-John joined AspenTech in 2016. Previously, he was VP and CTO for ProSensus, Inc. where he led company strategic direction and operations for modeling, monitoring, control and optimization of a wide range of process systems. Prior to that, he worked as a process control engineer, primarily in food processing plants. He holds a Ph.D. in chemical engineering from McMaster University.
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