Getting More from Bioprocesses: Increasing Productivity with Process Intensification
The biopharma industry wants the capability to increase biomanufacturing productivity on demand. See why process intensification is the best way to achieve this goal.
This article is posted on our Science Snippets Blog.
Things change fast in biopharma, and product demand is no exception. No matter how big your company is, resources like raw materials, personnel, and physical space eventually reach their limits when you strive to increase productivity to meet high demand.
Process intensification allows you to get more product out of your operations – often with better quality – with less resources engaged. Simply doing more of the same old thing will only take you so far; bioprocess intensification is how you enhance your existing processes and take your production capabilities to the next level. But before we dive into how you can implement process intensification for biomanufacturing, let’s take a look at why you might want to increase productivity in the first place.
The First Decision Point: Why Increase Productivity?
There can be many factors that prompt biomanufacturers to increase the productivity of their facilities, either to make more of a specific biologic drug or to manufacture more different products at once. Some of the most common reasons to boost productivity include:
- Unexpectedly high market demand – Even after careful demand prediction analysis, market factors can change in ways that cause demand to exceed manufacturers’ expectations. For example, in 2006, there was a shortage of pediatric flu vaccines because the CDC unexpectedly expanded the recommended age range for vaccination.
- New therapeutic applications – Sometimes an existing drug gains approval for a new indication beyond its initial scope. In 2020, the FDA approved Epidiolex to treat seizures in a rare genetic disease when it had previously been approved only to treat two forms of epilepsy. As a result, the manufacturer expanded production capacity to serve these patients.
- Public health crises – An epidemic, pandemic, or other fast-arising situation can place sudden emphasis on specific treatments. The most obvious recent example is the COVID-19 pandemic, which caused shortages in azithromycin, propofol, and numerous other drugs used for treating respiratory diseases, while also massively expanding demand for vaccine manufacturing.
Whatever the reason for heightened demand, you want your bioprocess to meet that demand in a highly productive manner.
Build Better, Not Just Bigger
Next, manufacturers must decide how to go about making more biologic product. It may seem like the most obvious way to increase production is through scale up of your existing operations by building new facilities or using larger versions of the same equipment, like bioreactors. However, doing the same things on a larger scale gets expensive quickly, and you may not have the capital available to make this up-front investment.
With process intensification, you can implement new technologies and strategies that let you produce more without expanding beyond your existing facilities and infrastructure. In some cases, you may even end up reducing footprint, which allows you to make room for new production lines for other products or cut overhead costs. Process intensification also offers you greater flexibility in how you make productivity changes, since you can make iterative improvements rather than overhauling everything at once.
Even if you do opt to build new facilities to increase production capacity, it makes sense to take advantage of this clean-slate opportunity to build high-efficiency facilities. You can maximize new sites’ potential by incorporating process intensification tools – such as perfusion bioreactor systems – right away.
Featured Report: Process Intensification: Key Considerations and Expert Insights
Download this report to discover the top five areas in which process intensification strategies can help biologics manufacturers achieve their organizational goals. Get data-driven insights from industry leaders and experts, from pharma to CDMOs.
Key Considerations for Intensifying Process Productivity
Once you’ve decided process intensification is the best way for you to boost your productivity, you’ll need to go about crafting the unique intensification approach that works best for your organization and goals. Some initial questions to ask yourself include:
- How stable is your product? – Certain process intensification technologies offer stability advantages for biologics that are especially prone to degradation, allowing you to improve both yield and quality simultaneously.
- Can your downstream process manage upstream productivity without bottlenecks? – Process intensification helps you think critically about nesting individual changes into your entire bioprocess to unite and streamline your upstream and downstream processes. This helps prevent shortsighted changes that can limit overall efficacy. For example, an increase in bioreactor output must be complemented with purification tools that can handle product more efficiently or at higher volumes.
- Do you have the time and resources for process R&D? – To get the most out of process intensification, it’s worth taking time to closely examine your entire bioprocess to see where changes can be most impactful on your final output. As an added benefit, this will help you know your processes better and have a confident grasp of limiting factors going forward.
- Have you considered or conducted trials of bioprocess data analytics software to further develop your process? – Process Analytical Technology (PAT) and Design of Experiments (DOE) tools can suggest tweaks in your biomanufacturing process that you might not think to try. Specialized automated systems, like our Ambr® bioreactors, can help you efficiently screen for optimal conditions by conducting varied process runs in parallel. Each individual change that comes from these technologies – from shifts in media composition to changes in process run time – might seem small at first, but they can add up to full percentage point changes in productivity.
We cover each of these decision points and considerations in detail in our comprehensive process intensification report, which includes real-world scenarios and insights from bioprocess experts across the industry. For example, you’ll learn the differences between perfusion and concentrated fed batch bioreactors and how each can contribute to overall process intensification outcomes. We also discuss the latest advancements in intensified downstream chromatography tools and process optimization technologies that can help you remove cumbersome bottlenecks. To get more out of your bioprocess, download the report today!