Name:
Driving innovation in clinical research: a look inside Worldwide’s large molecule lab
Description:
Driving innovation in clinical research: a look inside Worldwide’s large molecule lab
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Duration:
T00H07M22S
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Upload Date:
2025-07-03T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
My name is Connor Kenney. I've been with Worldwide for 3 years as a scientist. When I started 3 years ago, I helped support the startup of a new large molecule lab. We basically started from scratch. The company had built out the lab space, bought the equipment, so I was responsible for really implementing all that equipment, installing it, qualifying it, writing the SOPs (Standard Operating Procedures), and getting trained on it and starting to work on assays to be developed and give us a product to present to clients.
There's a lot to learn in the bioanalytical industry, especially when you introduce the regulations. So, learning a lot about the regulations, the GOPs (Good Operating Practices), the GCPs (Good Clinical Practices), FDA requirements, ICH M10 requirements, all those types of materials. Worldwide has been really beneficial in terms of providing me with the information that I need to study. It's never been a place where they've just given me answers. They've always given me the materials to go and dig for those answers myself, which has been a great opportunity to learn and grow as opposed to just kind of being given information.
And the lab work as well. I had a background for undergrad and my master's. I had a background in bioanalytics, but my previous industry experience was microbiology. So transferring into more of a bioanalytical lab, learning all the different assays and platforms was another big challenge as well. But again, I've always been given the materials and the knowledge that I've needed to kind of go and grow myself.
It's given us the opportunity to work on projects from the early phase — preclinical — all the way through the end with late phase, especially if it's a biomarker-type product. You know, late phase is really focused on whether or not the drug works. And so one way that we can utilize our lab is to test biomarkers. If that's how the drug is supposed to perform. Like, for example, if it's supposed to decrease a biomarker like NFL (Neurofilament Light chain), we can track that. If it's supposed to increase certain biomarkers, we can also track that.
The other opportunity that they've given us is they've built a new state-of-the-art lab. Plenty of space for room to grow and continue to expand our instrumentation, our team, as the industry improves and grows. We can kind of keep track of where we're at in the industry, what [the] popular instruments are, technology platforms. And we can kind of expand and grow our instruments as well.
Automation has been around for a while. It's been a growing topic in the industry, for sure. We started with Teacan's and, you know, there's a lot of other platforms. And the more recent one is Hamilton. It's kind of become the leading edge over Teacan more recently. It's given us a lot of opportunities to not only perform the liquid handler, which is what it's meant for, but they also have the capacity to introduce external pieces of equipment and be able to program it to move the plate to and from these external pieces of equipment, turn on those pieces of equipment, utilize them appropriately, implement in a fully automated system to perform all of our PK, biomarker, ADA assays from start to finish.
Also, Hamilton, their software has a lot of capabilities that really introduce a lot more quality, improve the quality. They have a pressure monitoring system on the aspiration and dispenses of their tips, so we can track that we're accurately aspirating and dispensing. We have full rein of power to really develop and hone in all the liquid classes to properly aspirate and dispense whatever volume, whatever liquid we have. We can personally tailor our liquid class to perform at the best accuracy and precision from run to run.
And then we also have introduced a camera system and also an email system to keep track of the runs for when we're not in the lab. And that email system is further expanded to really be utilized as an opportunity for us to walk out of the lab and then if something should arise, which we don't normally plan for, but if there is an issue at any point, we'll get an email notifying us to go in and fix that issue and continue to move the assay forward. Being able to utilize this automation, they have a scheduler software that allows us to stack runs.
So, as opposed to one analyst running a couple of plates a day, maybe two or three, this machine will run up to 10 plates in one day. That's a standard 8-hour period. And it'll run it with the same efficiency, same accuracy and precision from one plate to the next. There's no issues with worrying about an analyst getting tired at the end of the day or trying to rush through it at any point.
VENUS software has really given us the opportunity to really expand our TLA (Total Lab Automation) system into what it is. I don't think that we could do what we have without that software. Being able to have the drivers and the capabilities to connect to external equipment and be able to control those equipments from start to finish is obviously a big part of it. Furthermore, like I touched on earlier, the liquid classes and all the extra stuff that you can really hone in on to make it as accurate and precise as possible from one run to the next.
And also built into that is the scheduler software as well that I mentioned earlier, giving us the opportunity to schedule out and stack multiple runs together. And then also in terms of the data that comes out of it, obviously the MST (Microscale Thermophoresis) produces this raw data, but the VENUS software has a trace file that gets produced each run, and we document every step of the way, what exactly happened and what position of each plate.
There's quite a few technical challenges that we didn't see going into it. First and foremost was learning how to code the system from start to finish. We had a lot of support and help from the Hamilton team and their field application specialists to really help us at least with our first project. When it comes to actually performing the assays, we have to make sure that the assays are robust enough to handle some of the time delays that the TLA system introduces. Naturally, trying to move a plate from one place to another as a robotic system versus a human, there's just a little bit of a time difference there.
So that's kind of one thing we had to worry about. Another issue has been how do we mix our samples and how do we utilize the liquid handler system to properly aspirate and dispense multiple times to mix these samples without introducing air bubbles? So we spent a lot of time in the very beginning really honing in our liquid classes and making sure that our flow rates are well developed and accurate and that we're getting what we want each and every time in terms of mixing and that we're not introducing any bubbles.
