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CellPort Connect - CC 101: We Hear You

Patrick, when you think about all the people with whom we've had conversations recently about the challenges that they're having in the labs, One of the biggest ones is just trying to get organized.

I would agree with that. I think the, the the challenge of coordinating projects, coordinating people reagents materials and focus of the labs in general. I would agree with you.

One of the things that CellPort was designed for was transitioning from research to GLP and GMP and you have direct experience with that in the absorption systems arena.

Yeah. What, what we saw in, in the process of Absorption Systems going from research models and characterization to taking it further to qualification, even through validation at some point was the complexity one of the cell and understanding how to characterize it, that is the conditions you would grow the cell, removing art from, from the individuals and turn it into a process and how we handle cells, how we generate data that is reproducible, how we introduce analytical testing with the cells and to see which of the tests are relevant and what they're telling us that today I think is, has been an ongoing challenge and I don't know how that's going to be corrected until we establish levels of baseline of a lot of the early research that we're doing and, and how we capture data and how we sort of standardize a lot of these procedures and processes in the lab.

When you've talked about CellPort in its genesis, you've talked about the problems of reproducibility in general, but in the cells in particular, is that something that you see as ubiquitous throughout the industry? Yeah.

Absolutely. Again, the cell being a living entity is, is one of the challenges in this, you know, in our life science space and the fact is that a living entity is sensitive to, to materials, temperature, people, how it's handled for those of us in the industry. There are people who are just very good in the lab and people who are not as good and that is just handling materials and executing on, on experiments that in itself hasn't changed a lot. What we see is things become hopefully more reproducible as we start removing the art of the individual and going into a process and, you know, we would hope that automation would take care of this liquid handlers would take care of this. In fact, I I think it's taking care of some of it, but the reality is when we're characterizing cells and trying to understand functionality and production of protein or we're editing it. It is still a bit of an art and we need to think about tools that start removing the art that are better at removing the art and moving more towards things that would ensure this sort of one data capture procedures more standardized.

And that's precisely, I think why CellPort has been created the way that it has been to have that traceability and transparency, to track all of the information, to have repeatable protocols that can be run again and again and again, to ensure that consistency. Not only that things are done the same way but that you can look back and see how things have been done, who did them, what reagents they did with. I know from your experience you've had absolutely, absolutely.

From the CRO space and working with clients that we're starting out in research and developing analytical tools using cells, they were doing it for ultimately a commercial purpose, which means we had to get out of the research mode and we had to get into modes that would ensure scale up, that would ensure, you know, the the rigors of getting something approved, whether I was a reagent, I was a a test system that needed to be implemented to release a product or actually the product itself and in that, in those steps, what we saw was is that oftentimes we failed many times trying to scale up and understanding the failures was actually very important in understanding how we were to be successful, but capturing all that in a standardized format over the time frames we're talking about, we're talking years here and during those years. I've got employees that are changing. People promoted. People leaving for another job. New people coming in as we're expanding. I'm introducing a lot of just end user scientist, user variability. How do I standardize that? How did I capture? How do they bring that under control and tools like CellPort were something in the back of our minds that said this could make a difference and we think it does and it's not only about creating those protocols that make things more reproducible, but also as you mentioned, the traceability and transparency of finding out who did what and when with what reagents and equipment. Absolutely. One of one of the challenges we have or we, we, we, we have and I think the industry still has is when things aren't performing the way they are and they performed in the beginning and they're not. Now, everyone asks the same questions. Who was the scientist doing the work? How many scientists were involved? What, what are their skill sets? What material was used? Did a reagent get swapped out? You know, coming off of COVID where there's supply chain issues and I had to change a particular ingredient in the media to another vendor. Did that have any effect on it? I move an assay from one location to another location and oftentimes we would see variability and the question would become well, what did we do there that we haven't done here? So these, these, all these components sort of factor in what we always wanted to see was and we wanted to see it as soon as possible. What were the variables that led to success in the beginning and what were those variables that we think changed that you were where we, we change? And we actually lost the ability to get the assay to pass and analyzing that quickly to identify where changes may have occurred is extremely important.

You, you've talked about the need to track and trace all of this information and that variability. The problem is from what we've seen talking to people, a lot of the problems are not really trackable or traceable in the current systems that they're using, they're not custom built for cells, which is why, why software was created that end in mind.

It's the foundation of why we built this in the early days of regulatory studies using cells. We were submitting experimental data based on the use of cells to the FDA and when you do that, you open the door to audits and they're, they're, they're free to audit and a couple of the early audits we had from FDA inspectors actually came in and highlighted a number of issues that yes, we had it all documented but it was scattered and not terribly organized. We had notebooks. We had QA that was creating documents and all of this, but the communications even with the email were sort of independent and in a variety of different locations. It became very clear for the auditor that if we had tied it together in one sort of entity, one sort of application, the audits would be much easier and when the audits become easier and you convey that it instills one, a lot of confidence in the auditor that the lab is under control, but two, it also ensures that your communication and everything you've done is pretty solid and that became a goal of ours and hence, that's why we built CellPort.

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