CellPort Connect - CC 106: Building Trust with Transparency

So, Patrick, so many of the people that we've talked to who are thinking about buying CellPort are using either Excel or Google sheets and paper, lab, notebooks. Google sheets is a free product. Excel and paper lab, notebooks cost dollars. What would you say to a CEO who's thinking about making an investment in CellPort? I would tell them at this point that the investment in CellPort goes far beyond just your initial focus and research. It goes into the realm of building your operation into a world class organization, a world class facility. There are opportunities that pop up when you master, especially in this emerging field. When you master cell culture, historically, we had looked at a at, at CellPort and building it for a particular area that was small molecules. Once we got the infrastructure and we, we put the software in place, the opportunities for cell and gene therapy became readily apparent because we had built an infrastructure and process that could go far beyond what we ever envisioned and I think people who are considering, you know, operations and growing and, and hoping that the experiments and the, the production and their successes if they do not occur. Building a state-of-the-art operation result in opportunities that you probably can't see on paper today, but we know that they're there in the future. In addition to pivoting to those adjacent opportunities, is there a similar opportunity when going from research to GLP and on to GMP? Oh, absolutely. In fact, because of the complexity of doing that, taking a cell process, whether it's an assay, whether it's a cell therapy, whether it's a diagnostic and going through that process. Remember all of these companies out there are faced with the same thing that is that they're starting out in research and trying to develop some sort of commercially viable solution. Whether it's a new CAR-T. Whether it's a biologic. They're all going through the same process, and it's still labor intensive and its document intensive CellPort actually structures that from being able to monitor and capture all of the process CellPort structures, the process and then turns that process into an asset. That's an asset that clearly from the perspective of technology transfer is something that is made much more easy by having all of this information in a very consistent format. It makes the ability to transfer that information, whether it's from one group to another or from one organization into another, a much simpler and quicker process. Absolutely, and I think that that also brings into this concept of scalability when my process is really structured, adding more people and expanding to grow. It also becomes part of the structure and the way we have set this up and the way it grows that becomes training on boarding becomes much more efficient. The training aspects of protocols and batch records that are combinations of protocols or things that definitely are much made, much more facile through CellPort in the new 3.0 version. So, Patrick, in my very first meeting with the potential customer when I started at CellPort, we were asked the question, what are you? Are you a LIMS? Are you an ELN? What are you? So, in terms of, are we an ELN? Are we a LIMS? Are we a manufacturing execution system or MES? If someone were to ask me that question today, my answer would be yes. We have aspects of all of those different things. We have the repeatability and track ability and traceability of the LIMS, the flexibility of an ELN master batch record. Give us some aspects of a manufacturing execution system. How do you answer that question? I answer it the exact same way. When we looked at this process 20 years ago and thought about it the way that technology had developed and what we were dealing with at that time required us to clearly define those things such as limbs and kind of ELN type space, but today, what we have done is we have focused less on trying to define the product as we are more interested in defining the process and when we define the process, we realized that there were components of all of those, you know, the LIMS, the ELN the QMS system, there were all components that were required for us to achieve what we wanted to achieve. So we created that and we were not interested in trying to fit one sort of conceived notion of what this is the process sort of required it. I did not want to bring in different systems for different functionalities. I did not need an inventory system. I did not need a a workflow system. I did not need a scheduling calendar. I needed it all together and that today, to answer your question, are we a LIMS? Are we an ELN? And are we a QMS? The answer is yes. Certainly underscores the focus on cells as you have many times said. Cells are the central focus of CellPort and that underscores all of the aspects that you've touched upon the ELN LIMS.QMS, MES, all of those have components that are in CellPort that are interwoven that allow you to go from research, to GLP, and GMP. That allow you to track and trace all the materials, equipment, people, protocols, events, everything that's necessary for managing cell culture, cell banking, cell passaging, and cell feeding. Anything that's related to cells or their upstream and downstream processes. So Patrick, one of the things that we've noticed in the SEO work that we've done, the search engine optimization work, that we've done, for our website you can see what people have been searching in terms of search rooms. One of the things that people are searching for is fixing their broken laboratory workflows. Why do you think that that is such a common term and why do you think that CellPort is particularly well focused on addressing that?I think the answer to that question is that most labs have are still in sort of siloed even activities from notebooks, to to word docs, and Excel and I think it's very difficult to get a picture of what is happening in the lab when you have sort of disparate types of data capture and interaction, communication tools, emails outside the system, email associated with something else. So I think part of the issue that the industry is struggling with is if I can integrate a lot of those components into one source of for lack of a better term truth, I think that's where a lot of the ability to set up systems and processes that is visible and interoperable. I think that is the core problem.One of the things that CellPort addresses with specifically that issue emails are critical. We use email all the time. We use slack messaging all the time. We use teams all the time. And those are, as you said, not the source of truth, but those pieces of information, those conversations that happen offline need to be brought back online. They need to be brought back online in a way that is trackable and traceable so that when someone leaves and their email evaporates, there's a record of those conversations having taken place. There's a record of having been notified that something happened. There's a record of that information being captured in the system in a way that future generations can see precisely what happened. Yeah.and II I think that one of the challenges that most labs have even is the the inability to see those conversations and the perspective and the angle I think it is one of the, the the absolute biggest challenges we have and had in the past is those gaps in communication that were not visible to everybody and that traceability and transparency is something that we definitely have heard from customers and have put into the new version of 3.0. So Patrick, you've talked to me about horror stories of audits in the old days where there were paper notebooks lined up.Because for cell passing one notebook will refer to something that may have happened, in a previous notebook and so forth, and so forth that that it's not in a system that's easily traceable back through the history. That is the audit of the past. What is your vision with CellPort for the audit of the future? What we see is the audit of the future is someone showing up at your door and the head of quality for your company picking up their tablet and meeting the auditor and taking them on tour of the facilityand with simply the top of the button, you can look at the protocol, you can look at the project. I can actually save all those for printing out at a later date. I can actually bring up the person who ran the experiments or job description, their qualifications for that job. I can bring up all the protocols. I can bring up all the QC tests. I can bring up the SOPs. I can bring up the conversations for those things that may have looked out of spec and the explanation for it. That's, that's the vision for the future and for those documents they want. I collect them in my little cart and I print them out and I let the auditor read them to the heart's content.So you're pulling in all the different aspects that we've added in CellPort 3.0. The ability to have all the protocols, master batch records, batch record reports, all trackable and traceable every piece of equipment, every cell, every reagent, every consumable, every disposable, all of that track traced in tied back to the not only protocol or batch record from which it came but also the operator date time, all trackable, traceable and fully auditable. The the calibration of the equipment the validation of the equipment, all of those reports at the touch of a screen.And that's where we see the future coming because the auditor now has been, has been presented with an entire picture. Imagine wanting to go back and look at data from two or you know, three months prior to an actual experiment that was performed. What were the justifications and the parameters of that experiment? One thing we have seen in the cell and gene therapy space that is extremely relevant to, to CellPort is the FDA looking at release data or experimental data or testing data and oftentimes because patient populations are relatively small, there's not huge amounts of data. How do you justify the conditions you, you use to either produce something or, or manufacture a product or do the analytical testing on it and what we had encountered in the past and we think is going to be much more in the future is the justification of where did those conditions come from? Where did the parameters for that test come from and they start looking back at qualification, qualification of the assay you developed to release a product, even potentially some of the considerations of research at that time. This is what the FDA would like to know. How did you come up with these conditions and to be able to take them back in time because it's all in interconnected is extremely powerful and it gives you again, when I'm working with these premise, I can look at the history of it over time. I can look at the history and evolution of the project over time to, to what extent would the ability to have the notes and notifications in CellPort be a part of that ability critical because oftentimes in these audits, notes are made in notebooks and word docs and there are comments that if they're not sort of the interchange between QC QA and the principal investigator or the scientists doing the work to understand what those parameters are in real time as it happened and to be to see it documented is extremely powerful, extremely powerful. Documenting those kinds of notes and observations could be a double edged sword. You're documenting the good you do, documenting the bad, and you're documenting the ugly. That's part of the game.That's, that's the world we live in and being transparent to the auditors, especially in this emerging field. There is an understanding at the FDA, at the EMA, that this is not a perfect world. What they want to see is what happened, and do you have a hypothesis as to what happened, and can we check on things that had occurred? This is what have a tremendous interest in and it actually builds trust. I think with the auditors, if something is truly wrong, you would want to know about it. The worst thing that can happen is something truly wrong occurred, either you didn't know about it or it wasn't presented correctly. In this case, we're saying our position is transparency is sort of the best medicine documenting the what goes bad, could also be accompanied by documenting the why for why you think that happened? Absolutely, and it can also be a discovery moment too so we view that the the transparency and the communication. We view that as a very positive thing.

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