Natalie KuldellHost
00:02
Well, welcome everyone to the Thursday online session for our apprenticeship challenge for this spring of 2024. It is really nice to see folks logging in For the students who are here. As a reminder, if you could put your school name into the chat, it will help us know that you are here and we can mark you as present. This is the first of the Thursdays that we will have over the next eight weeks, so thank you for joining and for getting us started on this part of the learning.
00:37
The way these Thursday sessions will work is that we have the nice opportunity to work and speak with somebody who’s in the field of biotechnology, biomanufacturing, synthetic biology, bioengineering, engineering, writ, large science, engineering and, with those conversations, just open up, pull back the curtain a little bit on what these kinds of careers look like and how people get there.
01:02
That conversation will start for about 15, 20 minutes of every session and then we will move on to the learnings and the lesson plan that we have for this time. Largely, it will be me, Natalie Kuldell, running these sessions, as well as Hiroko Kaczmarek, who will also run these sessions, and Nancy Otaluka, who is a former apprentice and now one of our teachers, which is just such a joy, and we have a couple of others pinch hitting on occasion. So with that, actually let me just start by welcoming you, Prasanna, to this group to be able to introduce yourself and your work so that we can get a sense of what it means to be in the field of science and engineering. So, thank you. Maybe you can introduce yourself and the company you work for and then we’ll talk a little bit about what you do and how you got there.
Prasanna NetiGuest
01:59
Okay, sounds good. Is it okay if I share some slides?
Natalie KuldellHost
02:02
Oh, let me do that, Let me. Maggie, can you give her? Do you have permission to share? I just switched it, so hopefully it will work.
Prasanna NetiGuest
02:15
Okay.
Natalie KuldellHost
02:16
There you are.
Prasanna NetiGuest
02:17
Okay, Awesome, All right. So my name i PresRato Neti. I work for. I’m a principal automation engineer at Stellix Global Services. I’ve been working in the industrial process automation industry for over 19 years and mostly in life sciences, pharma, and I’ve worked in R&D, clinical and manufacturing settings. I’ve also done some work with specialty chemical and pulp and paper, but that’s kind of not part of this. I have a bachelor’s of science in chemical engineering from Georgia Tech and I got a master’s in business administration from Babson 15 years later. So just to let people know, it’s always great to go back to school and expand your learning as you develop in your career. My hobbies are gaming. I like to puzzle I’ve been on a puzzling kick lately Music, and I’m a classic movie fanatic.
03:11
So, that’s sort of just the about me. In terms of my career. I started out after college working for Honeywell Process Solutions. They have a huge industrial process automation business, so it’s kind of like a small fish, big pond. I started out as an individual contributor and moved into leading smaller projects where we do deployments for customers of putting these automation systems in so that we could optimize processes at sites. Now I work for NECI, which is now Stellix Global Services we just rebranded today.
03:50
So very confusing. If you look me up on LinkedIn you might be a little confused, but so I listed both there. I started as a senior systems engineer, did that for about seven years and then wanted to kind of get more into the commercial side of things. So I moved into project management. I kind of grew through the project management organization for about four and a half years and then I decided, hey, I see technology really pivoting with Gen AI and all of this stuff kind of coming about. This is really going to impact how we work in lab space and we work in manufacturing and all of these different spaces. So at that point in time I was like ready to make the move back to being back to engineering, and so that’s how I ended up back as a principal, as an automation engineer again.
04:39
And in terms of my day to day, I design and deploy these automation solutions, but with various different systems for different customers. I do front-end engineering design, which essentially means you go in and look at a system and say, hey, what do you need to make your process work process? They’re trying to do. And then I translate that into the systems and ways of working that they that operators need to use to be able to make the process more efficient and repeatable. And then standardizing work processes that’s more of an internal organizational thing I do to just make sure we’re delivering consistently. And then I work across other business functions on different business initiatives as we, as we go through this rebranding and transformation. So that’s kind of my career overview. I have a few more slides about industrial process automation, but I wasn’t sure if I should get into it.
Natalie KuldellHost
05:38
I think that would be super helpful if you could just give an example of what I’m not sure that’s a commonly understood term.
Prasanna NetiGuest
05:46
Yeah, and that’s kind of why I was excited to present, because when I started in this field I didn’t really know how big it was, how much there is to it. So just a high level overview. When we’re talking about process automation on the industrial side, we’re talking about replacing manual steps with automated workflows, placing manual steps with automated workflows. And we do this through hardware, so you could think of transmitters in the field, electrical components for those transmitters for you to get the signal to a actual screen that you can see, the servers, the networking. There’s a whole digital stack that needs to be built for all of this data and information to come through, to be built for all of this data and information to come through.
06:34
And the reason why people want to automate their process people who work on a lab scale you know that you have to do things in a very manual way. But if you come up with a solution that could be marketed or sold or benefits a lot of people, how do you do that en masse? It’s very tough to scale that up with just manual processes. So automation helps you scale up, it helps you make, basically make bigger, more stuff. Words are hard today. So some other reasons process consistency, as people do things manually different. People do things differently differently, and if you’re making a drug product or something like that, you kind of don’t want inconsistencies in your process and how that process is being executed. So automation helps make that consistent. Definitely reduces human error because you have you have some machine there doing the thing, but you do have people overseeing that and making sure that things are going the way they should.
Natalie KuldellHost
07:34
So it’s not a set it or forget it.
Prasanna NetiGuest
07:36
It’s definitely something that operators interact with and that’s something we definitely take into account when we’re designing systems. Another big reason why you want to automate is data. Everybody wants to have data on their runs, right? If you do things manually kind of are constricted to your Excel spreadsheet. You might be typing things into and manually managing, but with automation all of those values and set points and process parameters can all be brought into a central database and tracked and historized and you can kind of see over each run how you’re doing and optimize your process accordingly. And I think I already talked about scale up. So there is something to be said about safety as well. When you’re talking about scaling up a process, you’re working with big equipment like huge pumps, huge valves, and it’s using automation can make that safer because you can build alerts and alarms to notify you when your process conditions are starting to get unsafe and you can start, you know, making work plans around that. Hopefully that doesn’t happen.
08:43
And that’s why you put automation in, but it’s another reason why automation helps. So I can go into this slide, but maybe I will. I’ll just touch on this a little bit. If I’m going over anything, just let me know, by the way.
09:01
Okay, so, in terms of, I talked about a digital stack before and it wasn’t very clear when I mentioned what that was, but there’s a lot of systems that you can use to optimize and build your process out. So when you have a process and you know the steps you’re going to have to put, have transmitters that read the different values coming from the various process parameters, you’re monitoring over the course of your process. An example of this is on a bioreactor. You want to monitor pH on a bioreactor to make sure that your cells aren’t, you know, living in an environment that is not happy for them. You want them to keep producing and in order to do that, you monitor the pH and if that pH goes out of line, you have equipment that then responds to that.
09:51
So, on the field level, we’re talking about, like all of the devices, actuators, sensors, valves. They’re valves that can open and adjust and close based off of different set points you want things to be at. So we’ll go a little bit more into that in detail. My background is kind of at this mid-level here between the control level and the supervisory level. So I’m good at taking those signals, putting them into a central place and then building machine interfaces for people to work with so that they can interact with their processes through digital means. So on the control level you have a lot of computing powers where you have your controllers, which are essentially processors that are not on a Windows OS because Windows crashes and you don’t want your plant to go down.
10:43
So you, you put, you put all of this stuff, you have all your computations, your calculations, your signals coming through a very, very centralized controller level type layer. Then you move all of that up to what I call the HMI layer, which is human machine interface, and that’s where people can interact with this information that they’re getting from the field. That information is important for operators to see, to see if their process is within the bounds of where they want it to be. It has indicators like alarms, notifications for when things are getting out of range and out of spec. So that’s really kind of where my background is and where I’ve lived for a long time.
11:27
And there’s also a historization component to this too.
Natalie KuldellHost
11:30
So all of that data that I mentioned you’ve got to data is.
Prasanna NetiGuest
11:35
There’s so much data. You can make so much data just from one batch run, but you have to retain that data because if something down the line happens to that batch, if there’s a recall on the product or anything like that, you need all of that historized data in order to go back and reference and see, okay, well, what were the missteps here and take it from there. So it’s a compliance thing, but it’s also data can be used to optimize your process. It can be used to especially now with generative AI, people are starting to build models to basically take okay, well, this is how my last run went. This is how much I used of everything all my raw materials. What is the best? Here’s data over 10 runs, how, what are the best conditions? What should we be doing to make this to get the most out of our raw material?
12:23
The next two levels that are higher up are my company also works with, but are not really my area of expertise. We have a manufacturing execution system. This is a operator interface that operators work with to assign batch IDs, assign codes to their runs so that when you and a batch ID is essentially like a number associated with your process run, when you’re making your drug or whatever you’re making, so that you can kind of backtrack it over time, like you can say, oh, this batch like, and again, it’s all, for you know when you distribute this stuff. If there’s recalls or anything like that, you have to be able to know, hey, which batches were impacted, and that particular ID gives you that information. You can also have all your historized data under a certain batch ID, which makes it a lot easier to search and find. Mes systems also help you track your raw materials going into your process. You build a bill of materials when you in your MES, when you start your process run, you start over the course of your run, you you start entering in data, or sometimes it automatically populates if you’re building your, if that’s how you build your stack, with what raw materials you used and how much product you made at the end of the day.
13:46
So MES systems do a lot of different things at the operational layer, but to kind of just boil it down to the two basic things that I’m mostly familiar with, that’s where I think they add a lot of value.
13:59
And in terms of enterprise resource planning, that’s an ERP, that’s a business system. So all systems have like a centralized business system they use to monitor costs, to monitor how much money they’re making and all of that. So what an ERP can do is extract data from an MES and see okay, well, how much is it costing me, or in a batch, and how much am I making off a batch, and you can kind of optimize your costs that way too. So there’s a whole stack of things systems, I guess and each one of these is a system in and of itself that you have to integrate in order to get that full stack experience. So that’s kind of in a nutshell. I kind of deep dive into my area of expertise, because it’s this is where I sort of what I know but and I kind of talked about this before with the transmitters.
14:55
So this is that first field level that I was talking about. You have flow control valves, level sensors, steam valve, here they’re all going into this control level which is your, which I have here what is called a PLC, that’s a programmable logic controller, and it’s one of those types of processors I was talking about. It doesn’t look like a server, it doesn’t look like a PC, it’s a. But it’s a computer and it’s sitting in a cabinet in the field and it’s doing its calculations and pulling the data and information so that it and then pushing it out to the, to what we call a SCADA system, and SCADA stands for Supervisory, Control and Data Acquisition. And it does just that. You can control your, you can, you can see the data, you can control your system from the system, you can acquire data from it, you can build trends, you can build charts to see how your runs went.
15:53
One other thing I wanted to kind of point out, because one of the kind of basic functions of controls engineering is control. How do you control something? So we have this terminology called PID, which is proportional, integral and derivative. It’s a basis from which you do control, and the best way I can explain it without getting too technical and too mathy is a thermostat. So when you have a thermostat, you set it at a temperature and if your room is below that temperature your heater kicks in. But then what causes that heater to stop? Well, you set a set point and once it sets that set point, there’s logic in the thermostat that says, hey, I’ve reached my set point, I don’t need to be on anymore, and it turns off, and then, once your temperature goes down again, it comes back on, and so that’s sort of how. That’s sort of like a very simplified version of how process control works. But you can have this type of control on a device level At this control level. You can have it in different places, but generally you’re controlling your process in this way, and this makes it easy for operators to put a set point in for a particular process parameter and not have to keep monitoring it and adjusting their flow or their pressure or their temperature manually to accommodate the process, to keep things at the right set point.
17:17
So, and last but not least, this is my last slide I promise I wanted to bring up a bioreactor. I’ve worked with so many bioreactors. My company has a bioreactor branch and so for me, bioreactors have a very. They have a special place in my heart. This is an example of kind of an industrial scale bioreactor. I think in one of my other pictures I showed more of a bench top bioreactor, but this is. These are the.
17:46
This is the type of equipment I’ve worked with in the past and they can be up to like 1,000 liters, 5,000 liters, they can get big and as you’re growing your cells you move them to different reactors so that those reactors can accommodate the size of the growth that you’re wanting to hit for your batch. So some of the equipment here that I’m talking about are on the field level of that pyramid that I showed before. We have a feed pump that puts, if you’re inoculating your batch or you’re putting media into your vessel to start your batch or you’re putting buffer in to control pH, you would do that through like a feed addition. So you put that into the top of your tank and then you have processed gases which you monitor, and you also have different set points for it, depending on your process. You might use air, you might use oxygen, carbon dioxide lots of different variables there that you can tweak, and it’s very process contingent.
18:43
So I just listed all of the things you would use. Not every process uses that. And then I noted the agitator, which is essentially like a stirring blender that is on a but with a huge motor that is on a big vessel, and what you do with that is you control speed.
19:01
So you give it a speed set point and it runs at that particular speed, or you tell it hey, I only want you to run at these certain points in the process and, based off of coding, it knows when to run and when to stop. Then we have the regular sensors, like vessel level pH conductivity. Those are just values coming into the system that we monitor and then also can control with through process gases, through additions and things like that. So if your pH is going high, you might want to add some acid, right?
19:35
I’m trying to like, think you want to bring it down, to make it more acidic.
19:40
So you add, and you, so your system is automatically adding and adjusting these things based off of given set points from these sensors. Thermal jacket so a lot of times with fire reactors you have a jacket because you don’t want to shock yourselves directly with hot or cold. I think that’s also something that’s very translatable from the lab space to the real world or to this sorry. And so with a thermal jacket your heat or your cooling on your, your reactor will go, you know, be be, rather will happen over a staged amount of time, as opposed to just immediate shock to the system, which might make the cells unhappy. And then we have a transfer pump which is, again, you can control the speed of that pump, either off the flow rate or speed, whatever, what have you and that’s to get your effluent out of your reactor, whatever product you’re trying to extract. There’s other steps downstream of this that also are applied in biological manufacturing processes. This is kind of core to most processes that I’ve worked with. So, yeah, that’s all I have in terms of slides, that’s fabulous.
Natalie KuldellHost
20:51
Thank you for giving us some insight into the processes behind the production of some of the materials that are necessary and that biology can make for us. What I really liked about this talk is that it emphasizes a couple of things that we’re focusing on especially now. Today, we’re going gonna be talking about data and data collection, and we are doing it at a smaller scale, and so we are learning how to keep a laboratory notebook and starting that process. Today, on a scale of one to 10, how important, would you say, lab documentation is for your work? 11, right, you know documentation processes.
Prasanna NetiGuest
21:30
Yeah, it’s a compliance thing. Right, you have to have all of this for compliance If you don’t have records to show the FDA of how your process ran it didn’t happen.
Natalie KuldellHost
21:38
It didn’t happen. So today’s talk is all about laboratory notebook keeping and process and data collection. So thank you for teeing that up. The other thing that you’ve set up very nicely for us is that on Saturday, the students are going to come back into the lab and they’re going to start to grow some cells. They’re going to use it on solid media, on liquid media. Now, of course, we’re doing it on a very small scale, but I love that with this presentation, you’ve started to introduce what industrial scale manufacturing of biological materials can look like. So the connection between what you do as an industrial process engineer and what the students are learning today and Saturday as we scale up the cells to make things that we want them to make, is really incredibly valuable. So thank you, thank you for taking the time to talk with us. You are more than welcome to stick around. We are going to cover some things Now.
22:31
Maybe, if there is a question, one question. We have time for one question from a student. If you wanted to maybe stop sharing your slides, and if a student wants to either come off mute or join us, you know, or put something into the chat, let me see you know, or put something into the chat. Let me see, is there anyone? Is there a student who would like to ask a question in the chat or by coming off of mute? They are probably a little shy. It might be the first day today. Yes, it is the first day today Online, rather. Yes, yes, thank you, christopher.
23:11
Well, thank you for a wonderful talk. It’s really fascinating what you do and it is an interesting pathway for somebody who’s super interested in science. Right, it is. You know the words operation and processing and things like that. It’s a great combination of engineering and science. So, yeah, thank you. Thank you so much for being here.