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The capabilities of KCAS Bio: PK, biomarkers and immunogenicity testing all under one roof
Description:
The capabilities of KCAS Bio: PK, biomarkers and immunogenicity testing all under one roof
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T00H16M37S
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Upload Date:
2025-05-22T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
The advantages to having PK, immunogenicity, and biomarker all under one roof for the Sponsor is, it gives us the ability to solve all those problems, obviously, and has a tremendous amount of advantage in terms of the ability to save you time and money. And what I mean by that for our Sponsors is, if we start on a given platform, for example ligand binding assay, any of that information that we glean from that assay that's not working can quickly pivot to our hybrid team and sort of vice versa, that's one major advantage.
Yeah, I think it's similar, right? You don't always know upfront what's the best answer and if you're having lots of options that Sponsor, again, can go faster; it's more efficient for them. They can get to the right technology as quickly as possible without compromising their study, their stability, their time, their money, all of that. Yeah, so that's a good point. The Sponsor sleeps a little bit better at night knowing that they don't have to have samples going to various laboratories, they don't have to worry about-- you can conserve the sample, it's a big benefit to be able to use less sample because it's all under one roof, so obviously, one aliquot can be parsed out to multiple service lines if needed and then if the drug has any instability, that has a lot of advantages to be able to take that one sample out, run it by LC–MS, for instance, and then flip it to ligand binding assays.
And then also I really do think that we can work in parallel, so if you are kind of under the gun a little bit and you don't have an exorbitant amount of time and you're still trying to figure out how to get your PK method up and running, we can just start it by LBA and hybrid and we kind of make it into a race, it's a lot of fun. Yeah and maybe the other part too, really, is I think it's a big investment for a Sponsor to pick a lab, to do their work and so having one MSA, one CDA, one kind of set of paperwork, speeds up their stuff, but also having multiple choices and plan Bs already, kind of back up plans, for if something doesn't work really gives them maybe peace of mind and options to kind of go forward instead of starting over if it doesn't work whatever they pick the first time.
And any remnant samples, we can go back and do retrospective biomarker analysis, it's all right there, so that can be done really quickly and really cost-effectively as well because you don't have to ship site samples all over the globe to get them, we already have them. If you do choose to do some retrospective work, we can really quickly get those samples analyzed for you. So we do a lot of PK analysis and we have lots of choices for that and I think what we typically would do is start with a really good conversation with the Sponsor to understand what are they trying to do and what might be the pitfalls or kind of caveats or things that they might you know-- molecule instabilities or something where it might help us kick a technology up front, so you know if they say, for example, you're going to have to differentiate one amino acid different from something else, that's going to kind of tell us up front okay a reagent from an LBA standpoint might have a hard time differentiating that.
Whereas, hybrid mass spec you can take advantage of the mass spec to really allow you to do that, so we kind of try to have those conversations early and often to allow us to help them pick the best technology and sometimes Sponsors will maybe have a preference up front, they're an LBA person, they're a mass spec person and sometimes we have to navigate that if we agree with that's the right direction and other times we'll say "we can do either, so [if] you have a preference, well we'll go that direction" but then we always want to go back and forth with the science to make sure that's really giving them the answer to help you know their drug development process so, it could be mass spec, could be LBA, it could be PCR, flow cytometry.
We get asked this one all the time right, oftentimes I think, Dawn, it's a conversation but we know like if someone's got a preference towards a platform, they're going to be more comfortable with that one. So if they, for example, have developed it internally by ligand binding assay, it's a natural progression to go to ligand binding assay, if they've used hybrid mass spec then it's pretty straightforward but typically when people are asking that, they've either had an issue somewhere and that's where they're looking for us to kind of say "hey, how do you solve my LBA problem?", that's usually where people start, that's kind of the default platform.
Or it's "hey, someone else tried it by hybrid" because of what Dawn just talked about, there is something unique about the drug that requires some sensitivity or even specificity that the ligand binding assay takes a lot more effort and work and you need to generate critical reagents and we can talk about how that's a key feature about how you answer this type of question and segues nicely because, when I talk about critical reagents, in order to do what Dawn was talking about in terms of single amino acid differences between your drug and some endogenous protein, we're going to have to generate a lot of critical reagents to do that. But the hybrid mass spec allows you to just pull the protein out, digest it, use the mass spec as a high-end really gives you the specificity and sensitivity you need. So note your question about what we recommend well, if you have no reagents right, a lot of people start at that, or you've got to use commercial reagents, there are good, you know, generic assays that you can do by ligand binding assay but often if it's a complex drug, something that might have multiple bispecific antibodies, some sort of fusion protein that's got a couple different valencies to it, we work with a lot of unique compounds that might be a bispecific that's fused to another bispecific and now you've got this quadrivalent entity inside of a well that requires some sophisticated bioanalysis and if you don't have the right critical reagents, certainly the hybrid mass spec is definitely a better tool if your reagents aren't, as I call them, like if there's promiscuity amongst the reagents and they're not picking up your drug specifically, the mass spec is able to clean that up on the back end. Yeah and if you have potentially an instability section — that's a part of the molecule you might be worried that could fall off — so then again to Dom's point, if you want to kind of multiplex and follow different parts of that molecule, it's easier to than always relying on critical reagents, although it's possible, to multiplex that and pick several different parts of that molecule and again that could lend itself to mass spec so it really depends on a lot of the questions we ask up front and what the Sponsor's preference is, but we try to you know get to those as quickly as possible so that we can give you the right solution. Just say you love LBA. I do love LBA, half of my work is LBA right? Yeah the front end so you know. You know, this is a great question that again we get asked all the time and we really do enjoy answering it. Yeah we see it all from any sort of conjugates to I kind of touched on those multivalent beasts that really we've seen a whole myriad of things and you know, molecule drugs, biomarkers, oligos, conjugates and the conjugates can be traditional drug conjugates with toxins and payloads, they can be siRNA conjugates, which are a little bit more popular lately and oligos attached to things or they can be peptides attached to things and any kind of, what I would call "Frankenstein" molecules right that you can put it together however you want, we've pretty much tried and seen. We can support gene therapies, right, lot of gene therapies so we've got PCR under the same roof that allows us to look at any sort of maybe PK or PD assay for support of gene therapies. LMPs is an area that we're very good at, lipids, biomarkers yeah, we can do them both by mass spec as well as by more PCR. Cytokines, yeah it just gives us a you know when we often talk about being agnostic to the drug type because we do see it all and some of the things that people are doing now is really creative where you dose with a second drug to release the first drug, yeah yeah, some of them are in like a like a trigger kind of a trigger assays and then there's prodrugs and what Dawn means by that is a drug isn't active until it gets into like a certain environment like a tumor micro environment and then the antibody binding site is freed up, it's got this little kind of cap on it and then of course it's a bioanalytical nightmare because now you've got this peptide that's released, so the FDA or regulations are asking about that but we know how to handle it all and we're pretty fortunate to be working with just about every cutting-edge modality on the market.
Yeah disease indications are a lot of fun for us so I mean most people when they think of drug development it's often immuno-oncology, right and that's certainly one that we have a lot of depth in. There's not a cancer type out there that we haven't been able to help treat, and then you know, we're in metabolic health and you can touch on that one, that's really popular, we're talking about GLP-1s and things like that, but that's it's not just limited to those types of oligos, we work with every sort of siRNA and whatever is on the market. Neuroscience, we do a lot of neuroscience both out of our European site for biomarkers as well as a lot of lipid panels so a lot of glycosphingolipids that we can do by mass spec and we do a lot of those for the Parkinson's and Alzheimer's, Gaucher's, some of those diseases. Like you mentioned, a lot of oncology, a lot of rare disease we do, so that's a big one yeah. And again rare disease a lot of times you have very limited patient samples, sometimes they're pediatric, then you have other issues around getting sensitivities and volume and that kind of goes back to all under one roof because you have very limited volume you want to split your sample as efficiently as possible. And then the immunogenicity portion of that becomes a little bit more than just you know you've got your oftentimes in some rare diseases or gene therapies, you've got multiple immunogenicity assays because you've got to worry about anybody against the therapeutic itself, the humeral response against the drug, as well as if you're transducing or introducing a protein to a patient that's never seen it before, you are going to have immunogenicity and that's going to have to be handled a certain way as well. Yeah and similar again, back to kind of the modalities I guess, you know, when you have an ADC or some of these complex molecules, you have a single sample that you have to split into three, four, five assays with a couple of immunogenicity, a couple of biomarker, a couple PK, whatever and so you want to conserve and save that as much as possible, so we you know look at all of those modalities, we look at all of those disease areas and then, we didn't really touch on it but we also look at almost every matrix that you could possibly get out of the body, tissues. Not just human matrix, animals, yeah we've worked on every sort of species, you couldn't name a species or a tissue type that we've worked with or haven't worked with, excuse me. It's pretty extensive and then getting back to even modalities like the gene therapy space, AAVs and things like that, we're able to do biodistribution studies on thousands of samples through our qPCR lab and we can turn those very very quickly and they can be done by LC–MS as well, so we really do have a just it's, you know, it's real-- I mean I love working at KCAS Bio, we can-- there's not-- our claim to fame is we can take on any PK assay on the market. Yeah, we can-- we can support PK and immunogenicity for every drug modality on the market. Well the other thing I guess, the other maybe plug to make or comment to make, right, is I think a lot of our employees enjoy it as well because you really get a lot of breadth and depth across all of these platforms, all of these technologies and so we get people that want to learn and are passionate about learning and driving the science and you know, every day you work on something new, I mean I've been in this you know, same for you, like 20– 30 years right? And every day you still learn something, you leverage all your knowledge and your tribal knowledge and all of the stuff that you can throw at it but then it's always some new challenge that really keeps everybody going. Yeah that's a good point, it's really fun to see all the up-and-coming, I'll say 20-something year olds, 30-something year olds that you know, I remember being that age and I I really enjoyed-- we do a lot of training internally, she and I, not just for a scientist but a lot of our Business Development team, our Commercial team and that's that's really a really fun thing to be able to do because it's all under one roof again.
Yeah, really our Sponsors benefit greatly from that because our-- all of our young scientists are getting-- you're better off-- it's the orthogonal approach to solving something is what we're really good at because we have so many platforms, so many experts, so many world experts in these things That, as a young scientist in our organization, if you're familiar with how to do a hybrid mass spec assay or an LC–MS assay, it it does help you think better about solving the LBA one in front of you, like that type of synergy is really, really the exposure for the scientists. Yeah it's very much problem solving, it's not just like-- the way I say, "always a hammer, always a nail" right, it's whatever is the best technology to solve that problem and think critically-- critical path experiments, how do we derive this, fast, efficiently, you know, correctly, all that. This is-- I'm gonna steal your thunder here, Sponsors will come to us and they'll ask what tool should I use, right, well we've got a really big tool chest right, maybe others might have a screwdriver that might just be a Phillips screwdriver, well we have a common screwdriver, a Phillips screwdriver, a buzz saw, a hammer, we've got all sorts of tools that we can help you with for PK analysis, as well as the immunogenicity.
Yeah the sun never sets on KCAS Bio today, right? That's what we say. So we're much more than a small molecule shop. As somebody who's been at the company for 12 years now doing ligand binding assays, obviously, we cover it all-- we have small molecules, large molecules, cell-based gene therapies, or what some call immune effector cell therapies, gene therapies, you know-- and gene therapy is a huge, huge kind of class of drugs, peptides, oligos, everything, right and we've got sites-- and we've got a site in Lyon, we've got a partner in Melbourne, Australia. I mean, like I said the sun never really sets on KCAS Bio so. Yeah, I mean I think we're an evolving company right? As the marketplace and the science has evolved over the years, back 10, 15, 20, 30 years ago, right, we were pretty much a small molecule kind of industry, right? The whole industry was developing small molecule drugs. In the last maybe 10, 20 years, it's made a pivot or a shift to large molecules, all of these complicated modalities that we talk about now so we always stay very evergreen as we-- as the science evolves, we evolve as an organization and we add service lines and we add technologies that will always be the critical path, key to solving problems and I think that really is what's allowed us maybe to grow so effectively and efficiently over the last 10, 15 years. We're a 45- year-old organization and yeah predominantly for the first 20-ish, 25 years, we were small molecules.
It's been a struggle in-- I don't know if that's the right word but it's been it's been it's been interesting that people still view us as small molecule although we work on protein mass spec, ligand binding assays, in fact, the lion's share of our business is in biologics, yeah for sure, versus small molecules. Again, I think it's a reflection of where the industry is today so we go with that, right? If it's 5050, if it's 7525, we'll evolve as that evolves.