Activity

Cierra Sharp - December 05 VIEW RECORDING - 17 mins (No highlights): https://fathom.video/share/ubEEAaxfyDsu-zh8ZtjyYzJJHsdf79_7 --- 0:01 - Sharp, Cierra N. (Norton Healthcare) Other than freezing, doing all right. 0:03 - Andrew Hartmann (UTAK Laboratories) It's 15 here today. Are you guys in a similar cold snap? 0:06 - Sharp, Cierra N. (Norton Healthcare) I think it's going to get up to 35 today. Ooh, balmy. 0:11 - Andrew Hartmann (UTAK Laboratories) I know, I know. I'll have to get my shorts out for that. It's wild to me, actually. I see kids wearing shorts all the time. My neighbor just this morning, I had my dog out, and I'm bundled up. I've got the hat with the ear flaps. His daughter comes out wearing, like, shorts and a hoodie, and gets in the car, and I'm like, what are you doing? 0:32 - Sharp, Cierra N. (Norton Healthcare) Yeah, no, I cannot handle the cold like that. 0:35 - Andrew Hartmann (UTAK Laboratories) Yeah, I guess different people, you know. But I do well in the heat, so that's where I shine. I don't do well in the heat, either. 0:44 - Sharp, Cierra N. (Norton Healthcare) I need it to be 70 degrees, and that's it. 0:49 - Andrew Hartmann (UTAK Laboratories) I love that cat in the background there. Oh, thank you. Is that one of your pets, or is that just artwork? It's just art, yeah. They're both threads. 1:02 - Sharp, Cierra N. (Norton Healthcare) Okay. 1:02 - Andrew Hartmann (UTAK Laboratories) My wife and I are trying to get a good picture of my last cat. We do that Pop Your Pup. I don't know if you're familiar with that company, but they do really cool artwork of, like, your pet. So we have, like, a real painting of our dog. We have one of our cats, and now we've got to get one of our other cats. But my wife gets me shirts made with, like, my dog's face on it and socks with my cats. I'm a little obsessed with the animals. Oh, yeah. I am, too. Yeah. Yeah, definitely check it out. Pop Your Pup. It is, they do some pretty cool stuff if you're into that. Okay. Sorry, not trying to sell you other people's products here, but. How are things going in the lab? 1:42 - Sharp, Cierra N. (Norton Healthcare) Very, very busy, but good. So, the reason why I wanted to put some time together is to talk about some new testing that we're bringing in. Plasma amino acid analysis, and I know you mentioned that in the past you all have done. Bye-bye. Custom QC for that. And the issue that I'm running into now is based on the test menu that I think we're going to have to have. I can't really find any commercially available QC that covers all analytes. And I don't really want to go through the process of buying a commercial QC and then having to make an additional QC for in-house for the ones that aren't covered. Definitely. Yeah, so we can totally do the combined panels. 2:29 - Andrew Hartmann (UTAK Laboratories) Kind of the first question to get into this is, are you currently up and running in your testing? No. 2:36 - Sharp, Cierra N. (Norton Healthcare) So we are planning, so we don't even have the instrument ordered. I'm hoping to get it ordered by the end of this month. That would mean that it would arrive probably in March. And so mid-March, April is when we would be starting validation with it. Yeah. 2:57 - Andrew Hartmann (UTAK Laboratories) And it's, the matrix is plasma. It to be plasma, not serum. Is that right? Yeah, it has to be plasma. 3:04 - Sharp, Cierra N. (Norton Healthcare) So we're actually doing two different things. We're just doing the standard plasma amino acid analysis. And then like a large cohort of the patients that have a diagnosed inborn error metabolism, PKU is the biggest one we see. The team wants to be able to do dry blood spot testing just for tyrosine and phenylalanine. And I'm thinking the way we could do that and make the QC for it is to get a whole blood custom control and then spot it onto the filter paper and then process it like we would our patient samples. So that one's a little bit more unique. 3:51 - Andrew Hartmann (UTAK Laboratories) He hears me talking about it. He's like, oh, I'm going to. I love it. So the way we typically do these types of QCs because Because there's an endogenous amount in the starting level of the matrix, usually what we do is we send a sample of it to the customer to run it before we manufacture it to tell us, you know, where these starting levels are at, and then our team can do the math to do the dilutions to, you know, dilute down or spike in to hit target concentrations. Now, if you guys aren't up and running and able to do that baseline testing, what we can do is we can try to source a third-party lab that can do that testing for us. So, in other words, instead of sending the sample to you, we would send it to another lab, have them tell us where it starts at, and then we can manufacture, you know, once we have those results. It is typically fairly costly for us to send it out to these labs because we pay, you know, usually it's like a per test or per analyte. So, you know, if it's one of those things we need to do for the first time because you guys aren't set up, you know, but I think any time, you know, moving forward after that first batch, it'd be, you know, best value is having you guys do your own. Baseline testing. But it sounds like at this point, probably going to be best to have a third party do their baseline. Is that right? 5:06 - Sharp, Cierra N. (Norton Healthcare) Yeah, I think so, if that would be possible. Because I would like to have like the QC and the calibrators, that was the other part, calibrators, like ready to go when we're validating the instrument. So like when we're doing our simple precision, we're using the QC that we're actually planning to use for patient testing. Okay. 5:28 - Andrew Hartmann (UTAK Laboratories) And you're looking to get us to make both the QCs and the cales? Yeah. So when we do QCs and cales, would you like same matrix, the same lot of matrix for the QCs and the cales, or would you like a different lot of matrix for the QCs than the cales? 5:47 - Sharp, Cierra N. (Norton Healthcare) Um, so thinking about moving forward in the future, would we always be able to get the same law? Do of matrix for CALS and QCs when we would need an order again? If ordered at the same time, yes. 6:06 - Andrew Hartmann (UTAK Laboratories) If you're ordering them at different times, no. Okay. 6:10 - Sharp, Cierra N. (Norton Healthcare) If we could keep it the same lot, then that would be ideal. So same lot of matrix. 6:18 - Andrew Hartmann (UTAK Laboratories) That also would help with the third-party testing cost because if we have to send two samples. Yeah, that's true. Yeah. Do you need separate lots for the standards used in the CALS and the QCs, or is it okay to use the same? 6:37 - Sharp, Cierra N. (Norton Healthcare) For those, we would need separate lots. 6:48 - Andrew Hartmann (UTAK Laboratories) Just kind of a heads up, that does increase pricing a little bit, just because we have to buy two sets of all of the drugs instead of one. And so if that ever changes in the future or, you know, pricing is it. That's another area we can look at that, you know, would kind of bring that down. 7:04 - Sharp, Cierra N. (Norton Healthcare) Yeah, and I'm like pretty, I'm pretty open right now. I'm just trying to see what my options are. So like whatever kind of quotes for different scenarios you can give me, that would help me a lot. So if you wanted to give me one with different lots, one with the same lots, that that would be fine. 7:30 - Andrew Hartmann (UTAK Laboratories) And then, so kind of when we do QCs and CALs, it's like three separate options that we have of like separation. So we have different lots of matrix, which we decided we're going to do the same. We've got different lots of drugs. We're going to quote two options, one with the same lot, one with a different lot. And then we have different manufacturing technicians. Basically, a different person will make your QCs versus who makes your calibrators. Any preference there? No. I'll probably just put that in as like best practice just to have a separate person. The only one that costs extra is the separate lot of drugs, so separate lot of matrix and separate technician, there's no additional cost, just when we have to buy the extra drugs. And then product design itself. So we're going to do plasma matrix. I'm assuming frozen form is probably the preferred form here. Yeah. 8:32 - Sharp, Cierra N. (Norton Healthcare) Do you know what the typical stability is for that? 8:36 - Andrew Hartmann (UTAK Laboratories) Our quoting team will kind of officially confirm, but typically with the frozen form we see a 25-day thawed stability and an 18-month shelf life. Perfect. That would work. I'm not sure how much stability data we have on these amino acids as far as our ability to make a claim. Yeah. know we're making them for a lot of other customers and they tell us it works, but for us to actually make a stability guarantee, it's a... Yeah. I don't think we've done that with amino acids. And that's fine. 9:06 - Sharp, Cierra N. (Norton Healthcare) We'll do our own internal stability, thawed stability, just to make sure. I was more concerned about their frozen stability because we would be ordering, you know, enough for a year, essentially. Okay. 9:21 - Andrew Hartmann (UTAK Laboratories) And as far as fill size per vial, do you have an idea of what you'd be looking for there? I don't know that yet. 9:29 - Sharp, Cierra N. (Norton Healthcare) So I'll have to look at that a little bit more because I don't know what the testing volume is for the instrument we're looking to get. So I will give you that information. 9:41 - Andrew Hartmann (UTAK Laboratories) Do you know, like, how much material you're going to use per run? 9:47 - Sharp, Cierra N. (Norton Healthcare) Um, I don't know the volume per, because we, we would be doing, uh, a calibration. Thank Motion Curve and QC for each run, and we'd be doing one run a day, but I don't know what volume the instrument requires. 10:11 - Andrew Hartmann (UTAK Laboratories) Is that something that would be, you know, pretty quick for you to turn around and get an answer on, or do you want me to just go ahead and get a ballpark something going and maybe do like a one mil fill just to get some pricing worked out and we can always dial in? 10:23 - Sharp, Cierra N. (Norton Healthcare) Yeah, I think if we could just go ahead and get it for one mil, I'll see if can get that information to you either today or Monday, but I don't know. I think all the information that I have, I'm not sure if that's in there, so I'd have to reach out to the company, and they're a little bit hit and miss getting back to me in time. 10:44 - Andrew Hartmann (UTAK Laboratories) Do you mind if I ask you what it is you're working with? 10:46 - Sharp, Cierra N. (Norton Healthcare) Yeah, it's Harvard Biosciences, their Biochrome 30 Plus Amino Acid Analyzer. Okay. 10:54 - Andrew Hartmann (UTAK Laboratories) I don't think I've heard of them before. Yeah, it sounds like there's... 11:00 - Sharp, Cierra N. (Norton Healthcare) Two main ones. There's the Hitachi for the United States. There's the Hitachi and then Biochrome. Biochrome's more common over in Europe, but they actually have developed a method for dry blood spot testing on an amino acid analyzer. Most people do it by mass spec. So we kind of decided to go with them because of that expertise. Okay. 11:30 - Andrew Hartmann (UTAK Laboratories) And then total volume for each product, do you have like a ballpark of like how many ML you'd expect to use in a year? 11:44 - Sharp, Cierra N. (Norton Healthcare) Um, no, I don't. Okay. 11:49 - Andrew Hartmann (UTAK Laboratories) So our pricing is largely based on volume. Essentially, like the more that you can order in one order, it can significantly draw. The pricing. do now is just kind of put together a rough quote. So I'll do like a one mil fill size. I'll quote you at our minimum order size, which is like 50 ml. And I'll quote you at maybe like a 200 ml order volume just to get you, you know, a little bit of an idea of what volume pricing looks like. And then when we finally dial in, you know, fill size and total usage volume, we can kind of get to a final price. ACTION ITEM: Email Andrew analyte panel + 3-level vs 6-level CAL targets; then Andrew sends 1-mL quotes (50/200 mL, same/diff drug lots) + meeting link - WATCH: https://fathom.video/share/ubEEAaxfyDsu-zh8ZtjyYzJJHsdf79_7?timestamp=740.9999 But sometimes it's just easier in these projects to work with ballpark numbers just to, you know, find out if we're playing in the same field or not. Yeah. Okay. 12:30 - Sharp, Cierra N. (Norton Healthcare) I appreciate that. 12:31 - Andrew Hartmann (UTAK Laboratories) And then the other thing I would need is the list of all of the amino acids you want to test for and then the concentrations you'd be looking for. And if you could just spell out each of those concentrations for like all the levels of QC and each level of calibrator, that should be enough info for me to kind of get to work with our team. 12:49 - Sharp, Cierra N. (Norton Healthcare) Does it make a difference to you all if for each analyte they have different levels or versus like it's the same level for all analyte? because that's also an area where I'm a little bit flexible. When I reached out to Biochrome, like for their QC, for example, they essentially use a 50 for their low and a 250 for their high, and all analytes have that concentration as opposed to having a different concentration for each analyte. I didn't know if that made a difference or not. Not a huge difference. 13:27 - Andrew Hartmann (UTAK Laboratories) mean, we're very flexible, since this is something we're making just for you. It's pretty easy for us to do that. Kind of the one caveat is, if it lines up that a serial dilution is available, usually that makes for a little bit of a cheaper manufacturing process. Just because, you know, if we're making, let's say it's a seven-level calibrator set and we have to spike each individual seven levels with all of the amino acids, you know, that amount of spikes is a higher cost than if we're making the highest level at a larger volume. of in a bit know, but Okay. And then diluting it down with more of the matrix to kind of reach those others. But it's totally flexible. It's up to you. And if you want like 201 analyte and 100 in the next analyte and the next levels, 150 or something like that, that allows serial dilution. So it's a little easier on us. But most people don't have panels that align for serial dilution. So we're very used to making all seven levels individually, making all three levels of the CALs. I'm kind of assuming, is it seven level QC, three level CAL, or what are your plans? 14:32 - Sharp, Cierra N. (Norton Healthcare) So really, the only thing that's required by CAP is a single level calibrator, which I'm not comfortable with. So we would at least want to have three, ideally six. So I'm going to send you like an option one where we just have the three calibrators, option two where we have six calibrators. We're trying to get away from having to do AMR and linearity verification every six. for to months. So as long as we have a low, mid, and high level, we wouldn't have to do those things. 15:10 - Andrew Hartmann (UTAK Laboratories) Gotcha. Perfect. Well, I think this is enough information to just kind of get us off the ground, get a general quote. You know, we'll put a couple of options together based on what we talked about. So we'll do a couple of different volumes. I'll do same lot for Cals and QCs for the drugs as well as a different lot. But just kind of get an idea of how these things price out. When I have those ready, I'll probably just send you a link to have another quick meeting so we can just kind of review them together, get some live time feedback, and see, you know, what else we might want to edit or look into. Okay. 15:41 - Sharp, Cierra N. (Norton Healthcare) And I should have the names of the analytes and the levels that I want to see that list to you by the end of today. ACTION ITEM: Email Biochrome re: Biochrome 30 Plus run/vial volumes; then inform Andrew - WATCH: https://fathom.video/share/ubEEAaxfyDsu-zh8ZtjyYzJJHsdf79_7?timestamp=942.9999 Perfect. 15:53 - Andrew Hartmann (UTAK Laboratories) I'll send you an email kind of coming out of this more for my own self, just so I don't forget any of the details. So what I'm requesting, and then if you can just reply back with your Analyte panel, I'll get that over to our coding team. We'll go from there. Thank you. Yeah. Anything else you want to cover while you have me? Nope. I think that's it. Oh, actually, I did want to ask. The frozen urine. I saw that you guys ordered it. Working well? Any issues? 16:19 - Sharp, Cierra N. (Norton Healthcare) So we just ran our first round of samples this week. So Kelly and I are going to get together Monday and look at the data. Yeah. But the little sample that we got and we ran, it was perfect. Like, we were very happy with it. 16:37 - Andrew Hartmann (UTAK Laboratories) Well, keep me informed. You know, if you do have any issues, you know, please reach out. And also, if it's working, great. We love to hear that feedback, too. Okay. Awesome. Well, have yourself a nice day. Thank you. You have a good day, too. 16:49 - Sharp, Cierra N. (Norton Healthcare) Thanks. Bye. 16:58 - Andrew Hartmann (UTAK Laboratories) Bye. Bye. Bye. Bye. Thank