At a Glance
- The pharmaceutical and life sciences sectors have relied on conventional batch manufacturing methods as a trusted model for production requirements. For faster, more dynamic manufacturing, pharma companies like CDMOs are turning to continuous manufacturing.
- While continuous manufacturing offers more flexibility and agility, there are a number of practical and financial aspects that pharma companies need to take into consideration while making the partial or complete transition.
- Transitioning from batch manufacturing to continuous manufacturing requires pharma companies to be equipped with the right tools and technologies. For many, partnering with experts to seamlessly drive the transition and ensure employees are well-trained is essential.
For years, CDMOs have made do with solutions focused on batch manufacturing. Fast forward to today, however, and the world is changing rapidly, with newer more efficient technologies being introduced for more dynamic process management. While the pharma sector might seem hesitant to let go of batch manufacturing, more and more companies are slowly transitioning to continuous manufacturing.
The global pharmaceutical continuous manufacturing market is predicted to grow with a CAGR of 8.2% over the forecast period of 2018-2024.
With a growing number of benefits, including shorter production cycles, no equipment-stop requirements, and reduced risk for things like manual errors; continuous manufacturing is being viewed as the next big step in pharmaceutical manufacturing. In addition to the benefits, however, businesses need to expect any financial, practical, and behavioral hurdles that might arise.
This article aims to highlight these hurdles for organizations comparing batch vs. continuous manufacturing in order to gauge respective pros and cons.
Continuous Manufacturing and Its Impact on the Pharma industry
Continuous manufacturing is a highly streamlined ecosystem where multiple stages and discreet testing across various facilities are not required. For pharma companies, this can mean avoiding excessive downtime or closures of production units in the event of a faulty batch, saving manufacturers thousands of dollars previously dedicated to these types of tasks.
Figure: 1Batch Manufacturing vs. Continuous Manufacturing
Continuous manufacturing is more flexible and dynamic in nature, allowing manufacturers to introduce changes with ease and efficiency. In comparison, batch manufacturing in the pharmaceutical industry has always been highly restrictive in nature. Continuous manufacturing enables pharma companies to lower their carbon footprint, reducing any harmful emissions released into the environment and does not require the longer ‘hold times’ familiar to batch manufacturing, where between every stage materials need to be tested for quality. The transportation and storage of these samples (which are often in bulk) require both high costs and a planned holding time. These hold-ups and more can be mostly mitigated with continuous manufacturing. Companies can also significantly reduce the manufacturing lifecycle, including time to market for a drug. The single production line model found in continuous manufacturing works well to save time, leverage process flexibility, and enhance resource utilization.
3 Hurdles Implementing Continuous Manufacturing
With so many apparent benefits, it’s still a question of why the pharma industry hasn’t gone all out when it comes to continuous manufacturing. The answer lies in understanding the hurdles involved in implementing continuous manufacturing. Listed below are 3 common hurdles to consider when moving to continuous manufacturing.
1.InfrastructureContinuous manufacturing is typically considered a more advanced business model, often requiring changes in infrastructure across different functional areas. The IT framework of pharma companies and CDMO’s needs to be able to support an agile, flexible manufacturing model. Many pharmaceutical companies are still apprehensive to transition to continuous production as it usually entails a major infrastructure overhaul.
2.Regulatory IssuesPharma manufacturing is highly sensitive in terms of quality checks and regulatory approvals. After working with batch manufacturing for decades, a transition to continuous manufacturing means applying for newer approvals and altering quality check-points. For current product lines, pharma companies already have all their approvals in place for the production lines and quality check methods. Getting approvals for newer methods and production lines, like those found in continuous manufacturing, can be a costly and intimidating process.
3.Behavioural ResistanceCompared to other industries such as automotive or even chemical, the pharma sector has always been rather conventional in its approach towards newer methods and technologies. Implementing drastic changes has always been met with resistance as it can lead to numerous major shifts in processes, work methods, and operations. Employees need to be properly trained and made aware of possible hurdles when it comes to adopting a new process. For Pharma companies, this is best handled by letting change cascade from upper management, on down.
The Right Path for the Pharma Industry
With so much impact and so many possible benefits, the application of continuous manufacturing will continue to rise for businesses in the pharma sector. Going forward, precision medicine, personalized care, and agile transformation will continue to be of utmost importance for CDMOs and pharma giants. While these goals and more can be met by embracing continuous manufacturing, in order to achieve these targets, pharma companies will need to be willing to make necessary changes to their infrastructure in order to make a smoother transition to continuous production.
Key Takeaways
- The pharmaceutical industry can take advantage of numerous benefits and opportunities with continuous manufacturing vs older batch manufacturing processes.
- While continuous manufacturing is on the rise in the pharma sector, companies need to plan appropriately to ensure a smooth implementation/ transition.
- Pharma companies need to be open to changes in infrastructure and mindset to take full advantage of a continuous manufacturing model.
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