Getting More From Bioprocesses: Increasing Productivity and Efficiency with Process Intensification
The ability to increase biomanufacturing productivity is a top priority within the ever-evolving biopharmaceutical industry. See why process intensification is the best way to achieve this goal.
This article is posted on our Science Snippets Blog.
Requirements change quickly in the biopharmaceutical industry, and product demand is no exception. Regardless of your company’s size, resources like raw materials, personnel, and physical space eventually reach their limits when you strive to increase productivity to meet high demand.
Process intensification enhances your existing processes and elevates your production capabilities by enabling you to produce more output—often with improved quality and reduced costs—while engaging fewer resources. In this blog post, we will dive into how you can implement process intensification for biomanufacturing, but before that, let’s 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, whether to make more of a single product or to manufacture different products. Some of the most common reasons to boost productivity include:
- New modalities and molecule design – There has been a rapid growth in complex molecules, and the industry pipeline consists of numerous molecules that are less stable than traditional recombinant proteins. These molecules require suitable yields, optimum scalability, and appropriate quality to make it to the market. The manufacturing plant needs to be agile, flexible, and efficient to adapt to these market demands.
- Niche therapeutics and regional manufacturing – With many blockbuster drugs coming off patents soon, there is an increased development of biosimilars. There is also an expectation to produce these drugs more regionally to reduce costs and improve patient access to affordable, lifesaving drugs.
- Variable demands and increased costs – There are more and more drugs whose overall demand is not in tons of kilograms. Almost 50% of drugs would have a demand of less than 100 kg/year, with almost 80% of drugs needing less than 500 kg/year of production. This puts significant cost pressure on the manufacturing facilities, and the current big facilities will be unable to economically and sustainably manufacture drugs at these demands. Process development activities must be optimized, and material, labor, operations, and construction costs must be reduced.
Build Better, Not Just Bigger
Next, manufacturers must decide how to go about making more of their product(s). It may seem like the most obvious way to increase production is through scaling up existing operations, building new facilities, or using larger versions of the same equipment, like bioreactors. However, doing the same things on a larger scale is resource-intensive and gets expensive quickly, and you may not have the capital available to make this upfront investment.
With process intensification, you can implement new technologies and strategies to produce more without expanding beyond your existing facilities and infrastructure. In some cases, you may even end up reducing your footprint, allowing you to make room for new production lines for other products and cut overhead costs. Alternatively, you could build a more agile modular facility with a much smaller footprint requiring reduced energy, HVAC, and overall water usage, improving overall sustainability. 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.
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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 strategy that works best for your organization and goals. Some initial questions to ask yourself include:
- How stable is our product? – Certain process intensification technologies, like perfusion, offer stability advantages for biologics that are especially prone to degradation, allowing you to improve both yield and quality simultaneously.
- Can our 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 operations. 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 the product more efficiently or at higher volumes.
- Do we 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.
- How does our process and facility influence our overall sustainability? – With the recent emphasis on bioprocess joining hands in making manufacturing more sustainable, think about your facility requirements in terms of how energy, water, and HVAC can lead towards reduced carbon emissions.
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!