PODCAST: Automation Beyond the Strip: Building Repeatable Rapid Test Production with KinBio

Mitzi Rettinger: Welcome back to Expert Insights. I'm your host, Mitzi Rettinger. Quick disclosure before we start, KinBio supported ALFC 2025 and today's conversation is sponsored in that context. That said, the goal here is education. We're going to talk about manufacturing and quality control considerations for lateral flow and other rapid tests, especially what tends to change when you move from a benchtop assay to high-throughput manufacturing. I'm joined by Daniel Levenson, Business Development Manager at KinBio. Daniel, thank you for being here.

Daniel Levenson: Thank you. Mitzi, it's great to be here.

Mitzi: You came into this from the technical side, not the commercial side. Can you introduce your background and tell us a little bit more about the kinds of manufacturing pain points you were seeing firsthand, and how that led you to your current role?

Daniel: Absolutely. My roots are firmly in the lab. I spent years in the 1990s developing and manufacturing ELISA tests for infectious and parasitic diseases. I love the work, but when lateral flow technology started emerging, I saw the new frontier and wanted in. I joined a CRO called Logic Biotech, and they had just been hired to develop one of the first respiratory and lateral flow tests ever, an RSV rapid test. I came on as the lead scientist. Now, this was the early days of lateral flow technology. There were no established protocols. I was essentially building the plane while flying it. One of my first tasks was developing a reliable, scalable method for producing colloidal gold. That's the reagent that gives you the visible red line. If that reagent isn't consistent from lot to lot, then the test wasn't consistent. At the same time, I was deep in the chemistry of learning viral lysis, trying to figure out how to break open the virus to release its internal proteins, but in a way that's compatible with lateral flow and wouldn't interfere with antibody binding. And on top of that, we had to overcome the sample matrix effects from nasal swabs. It was a constant battle of troubleshooting, and every variable, from reagent volume to drying conditions, felt like it could make or break the test. That experience taught me something critical. A brilliant assay on the bench means nothing if you can't manufacture it reliably at scale. The pain points I saw inconsistent gold conjugates, antibodies that didn't survive the dispensing process. Membranes that behave differently from batch to batch. Those were the things that delayed products burned through budgets and caused sleepless nights for developers, I realized. The bridge between a great idea and a great product is manufacturing precision. That realization is what ultimately led me to KinBio and a founding of Gold Colloid Company. In my business development role, I'm not just selling equipment, I'm helping developers avoid those pain points that I lived through. I understand that when you're scaling up, the tolerances of your dispensers and laminates directly impact your sensitivity and reproducibility. So now I get to sit on the other side of the table and help people design manufacturability from day one, so they don't have to learn those lessons the hard way. Like I did joining KinBio was a natural fit because I already trusted the equipment from a technical perspective. Now I'm helping the company bring those solutions to a much broader set of users, specifically here in the United States.

Mitzi: Well, based on your history, Daniel, it does sound like KinBio was a great fit for you. So tell me a little bit more about KinBio.

Daniel: Sure. KinBio has been building tools for rapid test manufacturing since 2003. We are focused on the equipment and process steps that turn an assay design into a repeatable manufacturing process. Whether you're making hundreds of tests a day or moving towards higher throughput production. What that means in practice is automation and production equipment across the strip build and the downstream steps. Reagent coating and dispensing platforms, laminating systems, programmable cutting, assembly, coding, filling, labeling and packaging equipment. We supply certain consumables and materials that support rapid test manufacturing, so teams can source equipment and key inputs in a more consolidated way. And the reason we focus there is simple scale breaks processes. As volume goes up, small sources of variation become big problems for manufacturers. So we put a lot of attention on process control. One example is our vision assisted dispensing that's designed to detect and mark coating line defects early before they propagate downstream and show up as problems.

Mitzi: I want to come back to process control because that really sounds intriguing. But first, let's talk about a practical challenge for many teams. And that's evaluating equipment and process fit without burning through travel and shipping and guesswork. KinBio is building a more of a North American presence, including a San Diego showroom. What's the intended use case for that space from a developer's perspective?

Daniel: Well, we recognize that for US based diagnostic developers, seeing is believing. We are establishing a permanent showroom in San Diego. This won't just be a sales office. It's a hands-on environment where developers can bring their materials, see our automated dispensers, laminators and cutters in action, and run proof of concept tests. We want to be a local partner that provides global-scale technology with domestic support. The showroom is designed to feature KinBio's complete lateral flow production line of equipment, allowing customers to go from their own prepared reagents to fully assembled and packaged prototypes entirely within our facility. Within the workflow, we will also feature our high-throughput automated extraction tube filling system, which integrates foil, heat seal and printing capabilities. We are targeting Q3 of this year for our grand opening and will be operating under a new name, KinBio Nova.

Mitzi: Wow. You know, I, I agree that seeing is believing and so this makes a lot of sense to me. In fact, I've been in some of those showrooms where you actually get to use the equipment and it does make a huge difference. So that's exciting. Looking forward to seeing more in Q3. People often associate lateral flow manufacturing with only dispensing and strip cutting, but the real bottlenecks can be elsewhere, especially once you're building the kits at scale. Where do you see throughput and variability problems show up beyond the strip?

Daniel: The industry has definitely moved beyond the strip during the COVID-19 pandemic. The world realized that the bottleneck wasn't necessarily making the strip. It was the extraction tube, the vial filling, and the final kit assembly. This is because, for example, packaging and fill steps can affect stability, moisture exposure, seal integrity and overall lot consistency. Some examples of automation categories KinBio works in. For vial filling. We provide high-speed automated filling equipment for those extraction reagent tubes we've all become so familiar with. For end-to-end assembly, we offer fully automated lines that take the plastic housings, the strips, and the desiccant and assemble them and move them directly into foil pouching and laser coating.

Mitzi: I would really like to see all those in action. I'm that one at trade shows, that drives the business development people crazy, because anytime I see all of that automation and work, it kind of stops me and I just get fascinated. And then I have to ask all these questions on the actual equipment itself.

Daniel: Yeah, that's funny. I am the same way at trade shows. Mitzi.

Mitzi: So let's come back to what you said previously about detecting defects earlier in the process. If you're running high-throughput manufacturing, you can't rely on that end of the line sampling alone to catch issues that really matter. So how does KinBio think about in-line inspection and vision systems in rapid testing manufacturing?

Daniel: Sure, vision systems are most useful when tied to define critical-to-quality attributes. Common defect classes worth monitoring include membrane placement, alignment issues, dispensing defects, assembly problems. Ideally, what we want is an in-line system to do inspection during the production and flag, mark, and reject individual units without stopping the entire line. This is where our high-tech vision system sets us apart. Our machines don't just move parts, they see them. real-time inspection. The system performs 100% inspection during the production process. Defect marking. If the vision system detects a misplaced membrane, a streak in the reagent dispensing, or a housing that isn't seated correctly, it automatically marks or rejects that specific unit without stopping the entire line and data integrity. It provides the kind of traceability that's essential for FDA regulated environments. An important limitation to acknowledge is that vision systems can't replace assay performance testing, but it reduces risk by catching process and assembly defects early.

Mitzi: And from how you described that, I would I would definitely totally agree. Looking at 2026 and beyond. We're seeing more multiplexing and more complex point of care formats. From a manufacturing standpoint, what changes when a test goes from one target to several, or from a simple housing cassette to a more complex device?

Daniel: Sure, the trend is definitely towards point of care complexity. We're seeing more lab-on-a-chip style lateral flow devices that require multiple reagents or intricate housing designs. From a manufacturing standpoint, this means they move toward multiplexing and semi to fully automated flexibility. For multiplexing. It increases the manufacturing complexity, more dispensing events, tighter placement tolerances, and more opportunity for variation. Supporting additional lines increases the need for consistent line morphology and placement control. Our dispensers are now capable of handling more lines with higher precision to support four or five, or even six target tests. Semi or fully automated flexibility. Not every company needs a million tests a month. On day one. We stay competitive by offering modular solutions. You can start with a semi-automated setup for R&D or clinical trials, and scale into a fully integrated lights-out manufacturing line as your volume grows, We often see, for example, semi-automated manufacturing for R&D and clinical lots and then a push towards fully integrated, high-throughput automation when volumes justify it.

Mitzi: That's great. I you know, I when you were talking about modular design, I think that is perfect for this industry, especially when you think about all of the different sized companies that are looking at rapid tests and different types of products that come out. They could be for something that is never going to be a high-throughput assay, but it's really needed as a diagnostic. And so people are investing in that development but don't necessarily need that high-throughput equipment. And then just the reverse, you know, there's people who can move quickly through a development process and they need that big equipment quickly. So I like the idea that you don't have to start from the beginning, and you can kind of piece it together. Are you seeing that?

Daniel: Yeah, I see the same thing. And the modular design really allows us to cater to all the different levels of manufacturing.

Mitzi: What about this showroom? I can't I want to go see when I'm in San Diego because, again, it's exciting to kind of be able to touch the equipment, see how it's going to work. You said Q3?

Daniel: Yes, Q3 of this year. I've been working very hard putting all the pieces together and very excited for the eventual grand opening.

Mitzi: That's great. As you're looking at, I guess, having more of a North American presence, the showroom being one of the big, big things that you're doing, other things that you're doing that also are kind of increasing your presence here in the in North America?

Daniel: Yeah, certainly. Along with the showroom, we'll be putting on workshops, educational seminars. We'll be inviting people to our facility for learning and viewing all of our equipment in action.

Mitzi: That's great. That sounds exciting. Exciting for you certainly building it kind of from the scratch. That's pretty exciting.

Daniel: It is. Yes. It's a great place to be.

Mitzi: Daniel, this has really been interesting to wrap up. If you had to give developers one practical rule for scaling without surprises, what would it be?

Daniel: If I had to give developers one practical rule for scaling without surprises, it would be this. Design your test with your equipment's capabilities in mind from day one. Don't wait until you're ready for mass production to consider how your assay will translate from a lab bench to the production line. The critical-to-quality parameters that define your tests, like sensitivity and reproducibility, are locked in by the precision of your manufacturing process. So work backwards. Understand the tolerances of your dispensers, the consistency of your laminators, and how those factors impact your product performance. If you're designed for manufacturability from the very beginning, you ensure that your tests will validate and R&D the same at scale by the millions.

Mitzi: It sounds like KinBio is removing the manufacturing risk for developers so they can really focus on the science. Daniel, it's been a pleasure. Where can our listeners learn more about KinBio?

Daniel: Thanks, Mitzi. We want to be the engine under the hood. If you're in San Diego or coming for a conference, plan to visit our upcoming showroom and see what the future of LFA manufacturing looks like. Please feel free to connect with me on LinkedIn. You can also learn more about our products at KinBio.com.

Mitzi: Thank you, Daniel, and our listeners for joining us for this episode of Expert Insights. Don't forget to subscribe and we'll see you next time.