Formulating for New Product Scale-Up

Commercialization is a challenging time for many projects in the development pipeline. Every product developer knows this stage: You’ve just had your benchtop prototype approved and now must transition from making a small-scale product to producing a commercial-sized volume of the same item. Translating what worked well at benchtop into a ready-for-market product may seem simple to customers, but most developers will tell you it is anything but that. The good news is that there are several steps you can take to ensure success when formulating for new product scale-ups.

Essentially, product developers should complete a risk assessment with input from cross-functional team members. The product should be compared to currently produced products, and learnings will be pulled from those products. The decision of whether to do a plant trial will need to be made, including the details of the run, such as the quantity that would be produced. If run, that plant trial must then be evaluated for approval, and the resulting data used to update the risk assessment for first production. Let’s talk through these steps in more detail.

Assessing Risk

After a product receives bench approval, the team can begin planning what scale-up will mean for the product. At this stage, the team should conduct a risk assessment to predict and plan for challenges the product may face during commercialization. This process works best as a team discussion that includes product development, quality assurance and food safety, marketing, and production. Each group should document its concerns related to scaling the product. The team should then review these concerns together, recognizing that solving one challenge may introduce a new one.

For example, the production team may raise concerns about throughput if the product carries a “Handcrafted in Small Batches Using Traditional Methods” claim, noting that faster-paced automation may be necessary. At the same time, the marketing team may believe that consumer research will not support the price point without that claim. These trade-offs must be discussed early to avoid misalignment later.

It can be challenging to know what the risks might be in scaling a product.  

It can be challenging to know what the risks might be in scaling a product. There are many tactics to identify risks for risk assessment. If there are similar products, it may be beneficial to see where there have been challenges or failed runs with these prior products. If there are multiple plants or lines, identifying points of inconsistency in the process might help identify potential causes of inconsistency within the product. The same could be said for different ingredient suppliers. It may also be beneficial to go through the list of needed or desired attributes, which should include things like cost, availability, appearance, and taste. Understanding the priorities of the product and talking them through with the team may assist in making sure the concerns are identified.

Deciding on a Plant Trial

One common question is whether a plant trial is needed for a product. Plant trials can be expensive, especially if the finished product cannot be used in the market. It is worth understanding if there is a need for one, or if a smaller first production run would be better. There are many considerations that will go into this conversation and will need to be addressed.

The first step is determining how much product must be produced to replicate first production conditions. A plant trial should closely mirror actual production to provide meaningful insights. For continuous processes, this means running the line at full operating conditions. For batch processes, running at least a full batch typically represents the minimum requirement. Teams should also use packaging that reflects the final format to evaluate line behavior and conduct shelf-life testing. Depending on timing and launch considerations, the product produced during a plant trial may not be sellable.

The costs of skipping a plant trial can be high, especially if there is a target market release date. Plant trials, when run effectively, should give a preview of what will likely happen at the first production. If there are any issues that come up during the plant trial, it may be possible to try to correct them in real time during the run. If a change to the ingredients or any processing step happens, they should be documented to allow for detailed review of the run and approval.

After the run, teams should pull cases at random from the beginning, middle, and end of the trial, as well as from before and after any adjustments. When shelf-life testing is required, product from a plant trial provides far greater confidence than benchtop samples.

Preparing for First Production

Issues often arise during a plant trial. When they do, the first step is determining whether the issue was identified as a potential risk or has been observed previously. If so, the team may already have recommended adjustments outlined in the risk assessment. In other cases, unexpected challenges emerge. When this happens, the team should focus on identifying the root cause. The first thing to consider is what might be causing the challenge. If there is a color change in the process, for example, could there be a thermal aspect happening? If the product is a blend that doesn’t seem well blended, is it possible the component flow rate is uneven? Understanding the underlying cause is vital to prevent unwanted effects.

Once the team identifies the cause—or causes—it must decide whether adjustments can be made during the plant trial. Is it possible to change some aspects of the process or the ingredients to see if the product can be brought back into spec? There will be times when this is not possible, and the plant trial must be failed and evaluated in a postmortem to determine if it can be rectified and if a second plant trial should be run. If it is possible to tweak the process or ingredients to potentially alleviate the issue and it can be done during the allotted plant trial time, the team should note the exact time of the changeover and product pre- and post-change should be pulled from the line to conduct a comparison.

Understanding the outcome of the plant trial can help prepare for the first production and help predict what might happen.  

Planning for first production begins with reviewing the updated risk assessment and the results of the plant trial. During this step, the team should use plant trial data to verify assumptions and update the risk assessment accordingly. It is key to discuss any outcomes of the plant trial that were unexpected. Are they likely to be seen again? Did the product from the plant trial meet the specification through the entire run? Was any of the data from the plant trial following a trend line? Is it likely that if the run were longer, the product would have fallen out of specification? These questions should all be considered in the preparation for the first production. Understanding the outcome of the plant trial can help prepare for the first production and help predict what might happen.

While the plant trial should be conducted to provide the best simulation of first production possible, there may still be some key differences, and it is important to identify these differences. If there is a change in the equipment, the line, the ingredient suppliers, or the length of the run, there can be resulting changes in the product. It is important to look at these changes and evaluate them as a team to conduct a follow-up risk assessment before first production. While there is data from the plant trial to work from and the plant trial should be considered, it is important to remember that every introduced variable can cause a change in the product.

Thoughtful Scale-Up

There will always be unknowns going into a first production. The goal of preparation is not to eliminate all uncertainty, but to reduce it as much as possible. In some cases, teams may choose to skip a plant trial when risks appear low, but doing so always carries some level of risk. Products that are less familiar, have a higher likelihood of failure, or involve large first production runs must carefully weigh the cost and time of preparation against the risk of failure.

Thoughtful preparation cannot eliminate every unknown, but it can greatly reduce them—giving teams the best chance for a smooth and successful first production.