Tradeoffs to Consider While Implementing Process Intensification
As industries mature, there is a natural evolution toward technology and automation. The biopharmaceutical manufacturing industry is in the early stages of this evolution, commonly referred to as process intensification.
This article is posted. on our Science Snippets Blog
New technologies and automation require manufacturers to rethink their processes holistically. Still, a move towards process intensification can unlock significant savings, increase drug quality and patient safety and accelerate the way companies bring more affordable drugs to more patients.
But new technologies and innovations with the potential to improve efficiency and reduce production costs also come with significant challenges and tradeoffs. Biopharmaceutical manufacturers must be aware of the various tradeoffs and how they can impact their organization and their process. We investigate three common challenges below:
Challenges (and Opportunities) in New Process Development
The early stages of drug development are the most crucial time for defining the manufacturing process. Even before filing the IND, companies need to be thinking about:
- Molecule complexity and stability
- Drug quantities
- Manufacturing capabilities
- Maturity of available technologies
To develop an effective, safe, and affordable drug, companies must evaluate the manufacturability of the new drug without compromising drug quality. Biopharmaceutical manufacturing is a highly regulated environment that traditionally does not ease the adoption of new technologies.
Process intensification can increase throughput and lower costs by maximizing productivity and drug safety at every level of the manufacturing process. But companies must have a way to balance today’s demands with the promise of tomorrow’s technology.
Process Intensification Tradeoffs
In biopharmaceutical manufacturing, the shift towards implementing intensified process is not that simple. There are potential tradeoffs to consider and overcome.
Tradeoff #1: Improving efficiency (and proving drug quality) versus maintaining the status quo
There are plenty of new technologies available in drug manufacturing that can intensify processes:
- Perfusion cell cultures
- Rapid cycling capture
- In-line virus inactivation
- Flow-through polishing
- Continuous diafiltration
Implementing these technologies to intensify the manufacturing process with more automation and data processing undoubtedly improves process efficiency. But it can also bring up potential regulatory hurdles.
Most manufacturers are interested in adopting new technology, and there is a push throughout the industry to make that happen. But current good manufacturing processes (cGMP) set by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other international regulatory bodies are based on existing manufacturing processes. These have a proven history and dataset, ensuring the drug safety, identity, strength, quality, and purity criteria.
When companies want to introduce new technology for process intensification, they take all the risks of implementing—and proving—it can still meet all the cGMP requirements. That means collecting sufficient data to demonstrate that drug quality is not negatively impacted in any way.
Many manufacturers get caught in the balancing act of finding innovations that move the needle far enough to improve efficiency and reduce costs, without moving the needle so far that it could jeopardize regulatory approval.
Tradeoff #2: Finding and retaining top talent who can transition to “process controllers” versus “operators”
Process intensification technologies often require new technical skills and sophisticated process knowledge. For decades, employees in a biopharmaceutical manufacturing facility worked as operators—following step-by-step instructions to run the manufacturing process and maintain process controls in cGMP environments.
When companies move to more advanced technologies that automate more of the process, employees must transition to become process controllers—someone who can think strategically and holistically about the manufacturing process instead of getting bogged down in each step.
The COVID-19 pandemic has further heightened this concern, especially for highly skilled workers. There is a limited pool of skilled operators who understand process intensification and can take on the role of process controller, and a highly competitive market to hire and retain them.
Tradeoff #3: An end-to-end solution versus a complex supply chain
Manufacturers must decide between partnering with an end-to-end (E2E) provider or working with a network of supply chain vendors. Many biopharmaceutical manufacturers have moved toward a more complex and interconnected supply chain in recent decades. That can present some challenges when implementing new technologies for improved process efficiency.
The COVID-19 pandemic has also exposed supply chains not being robust or reliable enough to overcome an unexpected shock. Like millions of other businesses, biopharmaceutical companies are still working through surging demand coupled with limited supplies, labor shortages, and transportation challenges throughout the world. More than ever, manufacturers need strength and reliability in a supply chain.
Unfortunately, a global pandemic is not the only thing that might disrupt a complex supply chain with dozens (or hundreds) of vendors. More complexity means more opportunity for something to go wrong—from local weather that disrupts operations to political upheaval or raw material shortages in one part of the world.
E2E providers can minimize the risk that a single event in one part of the world disrupts the entire chain, but it is not without risk. The wrong E2E provider can also put biopharmaceutical manufacturers at risk if they are unable to deliver the necessary products or technologies. Efficient E2E supply chains aggregate technologies and communicate continually with end-users (drug manufacturers) to help minimize the downstream impact of any delays.
What’s the Solution?
The challenges and potential tradeoffs in implementing effective process intensification are real, but they are not insurmountable. Pharmaceutical manufacturers that partner with Sartorius can achieve:
- Faster drug development
- Higher productivity
- Lower cost of goods
- More flexibility in production
How is that possible? Let’s look at how Sartorius addresses the three tradeoffs above.
#1: Regulatory compliance
With Sartorius, you can conduct experiments on small-scale process innovations to determine how they impact the drug quality attributes. In most situations, you would have to replicate the same experiments every time you scale up production. But our processes are completely scalable, so the data you collect at the earliest stages of process intensification are still applicable at scale. Our designs ensure that manufacturers can move from the lab to product development, clinical trials, and eventually commercial development without the cost and time to repeat the same studies at every stage.
All the information is available and accessible so you can prove due diligence to regulatory bodies with comprehensive data to back up the results. This can save several months in research and clinical trials phases, so you can get to market sooner with a completely scalable process to manufacture new drugs.
#2: Making it easier to train process controllers
Sartorius solutions simplify as many steps as possible in the manufacturing process. In addition, Sartorius offers our team of application and product experts to provide support along the way, answering questions and helping your team get up to speed. We’re simplifying progress, so technological sophistication is more accessible than ever for drug manufacturers of all sizes.
#3: Complete E2E solutions
When you partner with Sartorius, you get a full end-to-end solution. We integrate the technologies necessary for continuous production with more automation. You can eliminate complex supply chains where a single interruption can cause severe downstream delays.
Companies can innovate and engage in process intensification with the confidence that you can get to market quickly with a high-quality drug that meets all regulatory requirements. Talk to us today to find out how Sartorius can help.