Navigating Complexities in Contract Powder Processing

TL;DR

Successfully bringing a new product to market, particularly in specialized fields like medical foods or advanced nutraceutical, requires a robust and adaptable contract powder processing partner. This discussion highlights the critical distinctions between lab-scale development and commercial-scale production, emphasizing that processes cannot simply be scaled linearly. For larger corporate entities, market testing and phased approvals are often integral, demanding a partner who can support a product’s evolution through various stages, from R&D to full commercialization. Precision in specifications is paramount, especially for sensitive applications like medical foods for children, where quality and consistency are non-negotiable. Our approach to contract powder processing involves a collaborative team effort, integrating process design, technical equipment maintenance, and the expertise of chemical and mechanical engineers. This comprehensive support extends beyond typical spray drying services to include aspects like liquid handling, ensuring a complete solution for our clients. We streamline the onboarding process through mutual NDAs, quality assessments, vendor qualifications, and structured questionnaires to meticulously plan and execute projects, enabling clients to achieve their objectives efficiently and effectively, regardless of project complexity.

From Lab to Commercial Scale: The Nuances of Powder Processing

Will: Yeah, and it sounds like you guys have the process so well defined that you’re able to help guide people through that in the process when they come to you, which seems like a huge help for especially some brands. Next question being, how do you validate that the powder you produce at commercial scale has the same performance characteristics, solubility, particle size, bioavailability as the original lab batch?

Hendrik: Yeah, that is, I have to think about that a little bit, but normally we don’t end up with exactly the same power properties and characteristic requirements that what we started with during the initial evaluation. What’s important is that as we go through the development process and we achieve different objectives with regards to each one of these performance characteristics, whether it’s solubility or particle size or bioavailability, it’s recorded and it’s transparent and it’s validated and it’s communicated with the customer and we agreed upon those requirements before we go to the next step.

And we will go through that validation and communication and agreed upon process during each one of these stages. Before we go into commercial scale, we know exactly what those requirements are and we know that it’s recorded and it was signed off on a specific document.

Tailoring Solutions for Specialized Applications: Medical Foods and Beyond

Hendrik: We agreed upon that’s what it is, and we also agreed upon how do we measure for each one of these. What SOP, what procedure do you use to determine solubility? What is the definition of solubility? The same with particle size, particle size distribution, density, and flowability, and all of these aspects. Every time before we go back into a commercial campaign, we will revisit that with the customer and we will reconfirm those specifications and say, yes, these are the ones that we require. Those are still the expectations. And then we know that we have the process parameters. We have the operating procedures that we can achieve that every time. We know that our dynamic atomization technology is completely scalable and repeatable. Once we have dialed in the process parameters and other settings, we can achieve that every single time.

Will: Yeah, I was curious to see how Hendrik would answer this question.

This is just evidence that we don’t rehearse these answers. It’s unfiltered and transparent, as I’ve said before. And it’s a perfectly valid answer. My response to the question honestly is why would you want necessarily the same powder at the commercial level that you had at the lab scale and the reason I say that it’s not meant to be a flippant response but it’s simply that you cannot do at the lab scale what you can do with our platform at the commercial scale whether we’re talking about the smallest dryers where we start piloting we start R&D and then pilot and then larger commercial scale because when we transition from the benchtop in the lab into that factory setting, beginning with the R&D scale dryer, the smallest dryer.

The Collaborative Approach to Contract Powder Processing

Will: That’s the stage at which we begin particle engineering. It’s only at that stage that we can start to move toward the ultimate design of the particle the way we’ve described in some of our discussions prior to this, it’s important very much as Hendrick has pointed out and as we’ve talked about before, to understand what is the client trying to achieve? What product are we designing for? What market? What application? What do we need that particle to do? And when we start at the R&D level in that factory setting, that’s when we engineer those particles to optimize for its intended use.

The lab scale, we just can’t achieve that. We do other things to prepare for it, particularly if we’re trying to deploy some of our other technologies.

Will: Tesseract’s delivery system uses cyclodextrin-based technologies and so on. And so there we’re setting the inclusion ratios. We’re preparing for the work that’s to come at those other levels. And that’s very necessary and valuable, but we’re not engineering the particle that comes later. And so we’re going to get much greater outcome and effectiveness and the types of things that we can only achieve, once we get to that stage.

Stephen Enloe

author