Scaling up a process: the questions that matter most

Moving from laboratory development to commercial production is rarely a straightforward step. Each stage of scale-up introduces new challenges, decisions and risks that must be carefully managed. 

One key point to remember when scaling up a process is that it involves much more than simply increasing the size of the equipment. At a much more fundamental level scale up is about creating a profitable business to deliver your product or process to a market. There is a wide array of questions to answer throughout your scale up journey to ensure you have the best chance of achieving a successful outcome, some of which of course are technical, scientific or engineering questions, however many of the most important questions are actually not technical at all. Alongside solving the various technical challenges associated with process scale up, teams must also consider key business questions such as: 

• How big is the market I’m selling into, and how much of that market do I realistically believe I can access? 

• Is anyone else already doing this? Who are my competition and what are they doing? How is my process or product different / better? 

• Is there a reliable supply chain which can provide everything I need to operate at scale, at a predictable price point that my process can afford? 

• Do I have the right team or support network in place to deliver everything I need? 

• Who are my key stakeholders and investors, and what are their motivations in their engagement with my business? 

Scaling up any process, and especially a bioprocess, is a complex journey, but fortunately it’s a journey we have taken many times at CPI over the last 20+ years, and so we have grown quite familiar with the route!

The most important question in process scale up – “Why?”

The first thought that you will generally have when thinking about scale up, is that this means running your process at larger scale. However, somewhat counterintuitively, that is not always the case. Scaling up isn’t just about running your process in larger vessels. In fact, often it is more valuable initially to continue working at smaller scale for longer, but critically, doing that in a way which generates data which is relevant to larger scale. 

When planning a scale up and commercialisation journey, there are many possible motivations to wanting to move to larger scale operation. If for example there is a need to produce larger quantities of material for market testing, validating performance on specific industrial equipment, or meeting an investor milestone, then moving as quickly as possible to larger scale may be the right choice. However, if the motivation is to generate data to develop a stronger understanding of process economics at scale for example, or to assess the scalability of your process and gain confidence that it will work and deliver the expected performance at scale, then these questions can often be answered much more cost-effectively at small scale. 

Using tools like Computational Fluid Dynamics (CFD), we can identify ways to operate smaller systems in a way that mimics the inevitable performance limitations of larger scale, enabling us to generate significantly more data and insight into process performance at scale, without the cost of actually operating large equipment. 

Of course, eventually you will need to operate at larger scale, but through this approach the risk involved and the likelihood of success of those large-scale runs can be significantly improved. 

Don’t lose sight of profitability and sustainability

One of the first things I was asked when I started out as a graduate engineer working in the iron and steel industry at the time, was ​“what does a blast furnace make?”, and I, as most people would, said ​“iron”. I was quickly corrected: a blast furnace, just like any other process plant, makes money. If it doesn’t make money, it very quickly won’t make anything at all. 

Therefore, it’s always vitally important to keep an eye on the economics of your process as it’s being developed and scaled up, to ensure it remains economically viable. It’s easy to lose sight of the economics whilst neck deep in solving scale-up challenges. You may encounter a process issue at scale which requires the addition of new processing steps or changes to operating conditions or materials to increase the performance of the process and improve yield or product purity. But we must always keep in mind that if the cost of the change outweighs the economic benefit of making the change, then it isn’t worth changing. 

It is easy to get stuck in trying to maximise the productivity of a process, however, through the use of approaches like Techno-Economic Analysis (TEA), you can determine where the sweet-spot is for your process to balance cost and productivity, and it may well be much lower than you think it is! 

Increasingly so, and for obvious reasons, environmental sustainability is also a key factor in the commercial viability of a process. If you are developing an alternative means of producing a product, does your process have a smaller or greater environmental footprint than the incumbent process? New processes with a more detrimental environmental impact than incumbents are unlikely to be accepted by regulators and by society in general, so minimising environmental impact is also something to monitor closely using Life Cycle Analysis (LCA) throughout your scale-up journey. 

To build, or to borrow?

A major reason for the ​“valley of death” in process scale up is the cost of buying pilot scale equipment. Businesses often need to invest heavily in assets that serve only a short-term purpose, long before their business is profitable. Pilot plants rarely operate economically; their role is simply to prove industrial feasibility and produce representative material. Once that’s done, the equipment is often no longer needed. 

Facilities like CPI help bridge this gap by providing open access, multipurpose pilot and demonstration scale equipment. Companies can use this equipment to test their processes at industrially relevant scale without major capital spend, focusing their funding on running their process, generating data, and producing materials needed to secure investment for full scale production. This shared infrastructure is essential for helping businesses scale up new processes much more quickly and at lower cost – significantly reducing the length and depth of the valley of death. 

Looking ahead

Scaling up a process is far more complex than simply making it bigger. It involves a wide range of technical and nontechnical questions that shape every stage of the journey. 

CPI has helped many organisations navigate this path by combining scientific, engineering and operational expertise with access to lab, pilot and demonstration scale facilities, alongside supporting businesses with market understanding, strategy development and access to funding. 

If you’d like to discuss your own scale up plans or explore how we can help, we’d be happy to talk.