Scaling up your microbial strain for commercial purposes is a highly complex process, and without the proper guidance, it can be hard to get it right. As your trusted CMO for custom microbial fermentation, we work with you to achieve your unique goals and drive your business forward. To help you get started, we asked our experts for their top tips to achieve success with microbial scale-up. Here’s what they shared:
Begin with the end in mind.
Each step of the custom microbial manufacturing process builds on the one before it. This is why we say you should “begin with the end in mind”—in other words, start with a clear vision of your final goal so you can select the proper upstream steps to get you there. To do this, ask yourself some basic questions: Will you need your final product in a powder or liquid form? If you need a powder, how should it be dried? How does your product need to be blended, packaged, and shipped?
Once you ask the questions, the next step is finding answers. Let’s say we’ve just completed the fermentation step, and we now have spore slurry that you need dried. While this may seem straightforward, there are multiple elements to consider before drying can occur, such as identifying your target yield, recovery rate, and processing time. The technology we select to dry your spore slurry will depend on your answer to those questions.
Scale down to scale up.
It’s important to factor in time for pilot-scale testing when you’re putting together a timeline for the rollout of your final product. Before full production begins, our team conducts thorough testing and analysis to identify optimal growth conditions for your strain. In order to scale up your strain, we scale down in the lab, adjusting variables like media type, pH, agitation, and airflow to determine the best conditions for your strain to achieve maximum growth. While it may be tempting to jump directly to large-scale manufacturing, taking the time to test your strain on a smaller scale will lead to better results in the long run.
Start with a high-quality seed strain.
At MDG, we take pride in the pure cultures we produce for our customers, with strain purity being an important element of successful scale-up. As our process development team is finding optimal growth conditions, they’re also ensuring that your strain remains free from non-target organisms. It’s important to do your part to confirm your strain’s purity before it’s sent off to your contract manufacturer; that way, the process can stay efficient.
Additionally, as your strain is scaled and tested, it goes through multiple generations. Variability and mutations can occur more frequently with each additional generation, so starting with a strong, high-quality seed strain may reduce that variability and increase the likelihood of achieving a pure final product.
Remember that time isn’t always money.
Timeliness is an important part of successful microbial scale-up; however, the quickest timeframe may not always produce the best results. What really matters is finding a growth medium for your strain that will keep it stable and achieve the highest yield within the most appropriate time. Appropriate is the key word here; sometimes, a higher yield will be produced in a medium where your strain takes a little longer to grow. Although there is a possibility that production will take longer, in the end, a stronger, more consistent culture today can save you from bigger issues tomorrow.
Choose MDG and Scale with Confidence
With our experts in your corner, you’ll be well on your way to achieving scale-up success for your microbial product. Ready to explore partnership options? Contact us today to speak with one of our representatives.
MDG is the Bacillus solution that helps you scale and streamline without sacrificing product effectiveness.
