Contract Spray Drying: Scaling from Lab to Commercial Production

TL;DR

Navigating the complexities of contract powder processing, especially in specialized fields like nutraceutical or medical foods, requires a nuanced approach that differentiates between lab-scale and commercial production. Our discussion highlights that while larger corporate teams often need to observe an evolutionary process for market testing and approvals, smaller, more agile teams might have clearer objectives from the outset. The complexity of project parameters, such as the stringent specifications for a specialty medical food for children compared to a more common product like powdered broccoli, significantly influences the process design. Effective collaboration is paramount; even though our core expertise lies in dryer process design and equipment maintenance, we integrate mechanical and chemical engineering support to offer comprehensive solutions, including liquid handling, to guide customers toward full commercialization.

When engaging a contract spray drying partner, critical documentation like mutual NDAs, quality onboarding, vendor qualification, raw material evaluation, and a structured questionnaire detailing objectives and timelines are essential for an efficient scale-up. It’s crucial to understand that lab-scale results rarely perfectly replicate commercial output, not due to limitations, but because commercial platforms, even at pilot scale, offer capabilities unattainable in a benchtop setting, allowing for optimized particle engineering from R&D through to large-scale production.

Tailoring Contract Powder Processing to Client Needs

Ulli: And it almost now seems as though, oh, wow, that’s really amazing what you guys have done with the versatility of your team that you’re able to create the space depending on what a client needs. Because, a client that does need market testing, focus groups, different approvals, different optimizations, and does truthfully, a lot of the time, the larger teams from the marketing perspective, in my experience, those larger corporate teams, they almost need to see the evolution of something go through it, where, smaller teams might be a little bit more agile and decisive and say, hey, what, we know what we want. It’s this. Here’s the change we need to make. Let’s do it.

Ulli: A larger team almost needs to be able to see that evolution for them to properly build the marketing team around it, build what the PR is going to be around it, have their packaging really honed in, have these processes.

And the fact that you guys are able to accommodate that, I think is honestly really important for some of these larger contracts. Likely.

Hendrik: Yeah. And in addition to, size, it also goes back to the requirements, right? So for example, if we are talking about a specialty medical food for children versus a making this up a powder dried broccoli for something, then, the criteria become a little bit different because, if you have a child with a metabolic condition or not in the prescription business or the pharma business, but you are getting pretty close because there’s a lot of concern on the parent side, on the consumer side, what, what does this, so those specifications are extremely precise.

Navigating Project Complexity in Specialty Applications

Hendrik: And they are very, very, very well defined. That’s another thing that, to keep in mind, the complexity of the actual project parameters also plays a big role., if I come and I say, can you spray dry, 500 liters of powdered broccoli that is in liquid that is different from, talking about medical food for children. Or a supplement that has very specific, let’s say, applications in the naturopathic health area.

Ulli: Yeah. No, and that makes total sense, honestly.

Will: Yeah, I would say that if you plotted all of our projects to understand the speed with which certain things were commercialized, the primary driver is going to be the culture of the client, and the secondary driver is going to be the nature of the project, as Uli points out. And I think for any company that’s out there that’s looking to engage in something like this, the way to understand whether or not the partner or partners they’re considering are the right partners is simply to, to ask a couple of questions. Ask what a business, in this case a business like ours, it does to support it. The first thing that Tesseract did when we entered into this business with APD was we doubled the R&D capacity.

Will: We wanted to be able to serve twice as many companies, projects, ideas, opportunities as we felt the business was able at the time, which was already considerable capacity. But we doubled our throughput with the R&D machinery and dynamic atomization technology we had at that smallest level. We have two R&D production lines. We can run multiple projects simultaneously every day. That wide end of the funnel, when we leap from benchtop and design in the lab to the production environment, we now have parallel teams operating every day. The second thing that we did was we took the entire factory setup from one shift to two. As things move from that small-scale R&D and piloting phase all the way through commercialization, we have doubled with an opportunity to triple our capacity there as well.

Will: That shows our commitment to the resources and how serious we are to make speed and throughput a reality for the customers who really need it. Our commitment is visible, and that’s as much as we can do. The rest is up to the customers, and we move at their speed. And so that’s the type of thing that I would encourage other businesses to look for.

Ulli: And I do think even just going back to the very beginning of that comment is interesting because you put it in terms of the first most driving factor or the largest driving factor of this being the client culture and placing more importance on that aspect of it because you guys are so versatile. That does show a testament to that you guys are putting client and their experience first, which is a big deal. I don’t think every company does that.

Hendrik: No, it is important because that goes back to the expectation management that Will was talking about earlier. Any development project, be it here in our, spray drying, dynamic atomization, it doesn’t matter. It could be any development project. It requires collaboration from very many stakeholders and it requires, keeping the timeline in mind and, being realistic. It’s interesting because many large companies will tell you that their development process is 24 months. And obviously in pharma, it could be 10 years, it could be 20 years. But the reason for that is often because they understand the limitations that exist internally in the organization and that there is a minimum speed and a maximum speed that the organization can provide as input into that development process.

Going on to our next question, which is, can you walk through an example of a product that had an unexpected challenge during scale up and how did your team solve it?

Hendrik: And this one we can go through pretty quickly. I can start and try to give you the short version of that. I wish that I could say that we have never experienced something like that, but we did experience something with a very recent scale of demonstration where the customer had a protein extraction liquid that we had to drive for them, and the customer designed the front-end process, the liquid phase, and we had to rent equipment to prepare the liquid material for the spray drying process. And obviously, so when we started the drying side of the process, the material conveyed it or it fed to the dryer, it atomized and it dried, but it did not want to convey out of the drying chamber.

Hendrik: We had to go through all the processes that we normally go through. Why is the product not conveying? Is it the moisture content? Is it the particle size? It’s the density of the product. And we just could not figure out why this product was not conveying. And then we went to the next phase and that is evaluate the liquid specifications of the material. What are the requirements? Is it the pH of the material? Is it the viscosity? Is it the salt concentration? and is it the particle size in the liquid itself and we found that the liquid handling side of the process was not efficient so the rented equipment failed so that’s why we had a product that we fit into the dryer that was not the product that we were supposed to dry and so the customer had to go back and redesign the process.

Hendrik: And I want to add here just very briefly that APD just did not step back and say, that is your problem. We can’t help you with that. We were very involved with helping them to look at additional vendors for the equipment, the sizing of the equipment, helping them to design the throughput of the, again, the equipment on the liquid handling side. And we are now in an additional phase where they went through the liquid handling process with a different vendor. And now we are back to a phase where we can try again this product. And now we have a product that’s in specification and that we can scale up to full production. There’s always these challenges that you cannot foresee and that you expect that these things would not be a challenge and that, everybody did their homework and things will work out.

Hendrik: But there’s always the human factor and there’s also equipment that fails where you’re not expected that. The most important factor here is that we are a company that’s focused on being successful, supporting customers for whatever that process is, to, have a long-term customer that we can do commercial production for.

Ulli: Yeah, and I think that the biggest green flag, so to speak, in that whole answer of things is going back to even what Will said before, where there’s always some expectation along the way that somehow has to be reassessed and somehow might be broken or somehow might not be met, but needs to be handled. And I was listening to an interview with a CEO of a major company that was talking about hiring. And specifically, I think it pertains to this with vendors where you don’t necessarily want to work with somebody who does it perfect every single time because they’re the best or this.

Will: You want to work with somebody who for a fact is going to figure out and solve the problem every time.

And in a process like this, it sounds like there’s almost an infinite amount of variables, but you guys solve the problem., you’re not in the business of just saying everything’s okay. You’re in the business of working through it with the customer and then coming out with the best solution that’s possible. That makes a lot of sense. That’s a really cool way of going about it. I appreciate that way of thinking, Stephen. And there’s two aspects of that. First of all, we exist in a world that has a virtually unlimited amount of detail, and it requires a vast detail orientation to chase down all these variables when you’re problem solving. And we accept the fact, A, that’s what we need to do, and B, that we have to be 100% transparent about it.

Will: Hendrick didn’t choose this example because it happened to be equipment that was brought in from the outside and is not part of our factory setup that we use. That’s not the point. It’s not meant to illustrate that it was, it came in from outdoors, but rather the complexity that we face and the fact that we have to leave no stone unturned. The second thing that I’d like to add to this though is that we apply an unusually high level of attention from all tiers of our business starting with me at the ceo level all the way through the ranks to every customer and we give them every bit of attention that we can and one very recent example of that is like every manufacturer, we are very frequently subjected to quality audits from all directions. We were notified by one of our very valuable customers who’s in the healthcare space that they wanted to exercise their right to audit us, which we love because that keeps us sharp and they set a date.

Will: And so the first thing that I did was I called their CEO and invited him to meet me there and attend the audit with me. I don’t think that’s something that organizations would normally do, but whatever happened, we felt we were prepared for it. We always feel we’re prepared for those things, but I wanted to have the opportunity to spend time with him and his team, his quality team, and give him the opportunity to meet our entire team. He took me up on the offer as many CEOs do, but it gave us a great chance to allow him to spend more time in the facility, talk about all the opportunities that we have and that we work on together and the future of our business, but allow him to see up close exactly how the product runs, how we maintain emphasis on quality, but make sure that anything that came up in that quality investigation, he heard firsthand.

Will: He didn’t hear it later from his quality personnel, sanitized, stripped down in the interest of just giving him a brief report. And that’s how we approach everything. We’re 100% transparent and open with our customers, whether it’s something that happened because we made a mistake or it’s something that we couldn’t have controlled and we’re just reporting it. But it’s important to have a partner, whether it’s us or someone else, who approaches every engagement the same way, because that’s the only way a business is going to be able to have the absolute best commercial result in the market.

Streamlining Scale-Up with Contract Spray Drying Partners

Ulli: That’s awesome. That’s such a cool way of going about that. And I think it shows through. I’m not surprised, but it’s, that’s a really, I think it’s a really amazing show of character of what you guys are about. And I think I mentioned previously, collaborative team effort, and that’s exactly what I wanted to refer to, is that even though we focus on the process design from a drier perspective, we look at evaluation of the process, we have the technical guys that make sure that equipment on our side works and that is maintained properly and that we have a proper process set up for that but we also have access to mechanical engineers and chemical engineers so anything that we have even if it falls outside of our realm of expertise we can support the customers so we can have a complete process even though it may include a liquid handling site that’s not normal part of our process that we can help and support when we can bring that customer to full commercialization yeah no that’s awesome so going on to the next question which we briefly touched on before when we were talking about the start of a process and when people should come to you guys but what specific documentation and data should a company bring to their meeting with a contract spray drying partner to make the scale up process as efficient as possible? I think you guys mentioned spec sheets and different aspects, but what are all those different documentation data points?

Hendrik: Will mentioned earlier that confidentiality is extremely important for us because we deal with intellectual property, we deal with customer formulations, we deal with formulations that we help develop for customers. The first thing that we always focus on is that mutual confidentiality agreement. Additional to that is the customer must have defined objectives and timeframes and expectations. We have the product development questionnaire that we provide to the customer, and we normally request them to complete that questionnaire before we have the first in-depth discussion with them. Because now we have exactly what other product that we are going to deal with, what is the objectives for that product, what is the delivery system requirements, the regulatory requirements, the timeframe requirements, and obviously what are the volume requirements for tall manufacturing.

Hendrik: And those are, I would say, the mutual NDA, the onboarding documents from a quality perspective, the vendor qualification, is there any raw materials involved that needs to be qualified and evaluated, and then the questionnaire that we provide to the customers to help and support them to give us the objectives and the time frame requirements in a structured way so that we can properly plan the process for them and with them.

Ulli: 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.

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.

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.