Experts Weigh in on the Role of Lab Automation and Sensor Technology in Advancing the Cell Therapy and Regenerative Medicine Fields
While there is tremendous excitement and ample investment around cell and gene therapy and regenerative medicine, several challenges, including scale-up, high manufacturing costs, and regulatory hurdles, continue to be impediments to the industry achieving its potential.
The lab automation and bioreactor control systems and the real-time data monitoring and collection made possible by sensor technology are playing a critical role in busting down these barriers for both large biopharma companies and smaller scale, emerging organizations. These technologies have the potential to improve quality, eliminate human error, reduce overall costs and increase FDA approval outcomes for more cell and gene therapy and regenerative medicine products.
In a recent webinar hosted by BioBuzz and sponsored by Lab Owl, experts weighed in on the latest advancement and trends in lab automation and sensor technology.
The live, virtual featured an outstanding panel that included Ohad Karnieli, the Founder and CEO of Adva Biotechnology; Vic Ronchetti, Senior VP, Technical Director at Lab Owl; and Jake Boy, Senior Application Scientist with SBI. The webinar was moderated by Lab Owl CEO Michael Blechman and John Moore, SBI’s President, and covered a wide range of topics including, but not limited to:
- Small Scale to Commercial Automation solutions
- Bioreactor control and information systems
- Sensor and instrumentation technologies for your lab
- Automation for autologous cell manufacturing
- Laboratory software and data solutions
“Over the past several years we’ve noticed a trend for biotech labs and small scale manufacturing to rely less on manual operations and more on automation…the industry is relying more on small scale production lines to optimize processes and methods so flexible, intelligent, scalable and modular automation and information systems are bringing tremendous benefit,” stated Blechman to kick off the discussion.
“The good news is that all these changes and challenges are driving technological innovation in controls and sensing,” he added.
“A theme we hear repeatedly is that the biopharma industry is chronically undersampled. There is a big push to go from offline testing to online, real time monitoring. This is the key to eliminating waste, increasing yields and lowering cost to consumers,” stated SBI’s Moore.
Key Steps to Moving from Static Culture Systems to an Automated Bioreactor
“The most important part is to understand how big of a difference this is. It’s like learning to walk…right now, science is more of an art. Scientists look at their cells and say now it’s the right time to replace media, I can sense the cells, I can feel the cells. In my hands and in my lab it works. But this is not industry,” stated Adva Biotechnology’s Karnieli.
“We need to really change something. When you transition from static to an automated system you move from thinking like a scientist to industry. It has to work every time, in every hand, and in every lab. In order to do that you need to understand what’s happening, you need to control. You need sensing,” he added.
Lab Owl’s Ronchetti shared, “I can’t tell you how happy I am to work with clients using a Lab Owl system and they have access to all that measured information…These are very smart people that understand the science but their backgrounds are not in control. To watch their eyes open up to their process and they have a better window into how their cells work. They’re smart and we’re given them the tools to enlighten them on their process.”
“This process is not manual and doesn’t have human randomness. You can build macros, which is what you’ve done step-by-step…and allows one to hone in on optimizing the process,” he added.
“You can program a macro that basically automates your steps, which eliminates mistakes and makes it simple. When you look at a multi-step process like CAR T, you can really automate the whole system and not just part of it,” added Karnieli.
How Does a Lab Get Started with Automation?
“A lot of times the hardest part of a project is getting started,” stated SBI’s Boy. “There is a lot of planning involved but the very first, most basic thing to start with are sensors. If you don’t have sensing you have no parameters to base your control off of. Macros need set points that are generated by sensor parameters as your cells are growing.”
Boy continued that often he and his colleagues noticed their cells were doing great but had no clear idea as to why. Sensing helps scientists understand what the cells are experiencing from the start to end of a process.
“You can build a process based on these sensing parameters that allows you to control what your cells are experiencing and feed them the metabolites they need as they’re growing. If you have sensing you can find out what the cells are asking for and then using the Lab Owl system you can provide fresh media, control for pH and dissolved oxygen and move towards taking the human element out of cell culture,” stated Boy.
How Does Automation Help Organizations Comply with the FDA’s PAT Initiative
The FDA’s Process Analytical Technology or PAT initiative is a new regulatory framework that will encourage industry to develop and implement innovation and efficiency across development, manufacturing and quality assurance.
“What this is trying to move biotech and industry from more of an R&D world to something that can be used clinically. The FDA wants to regulate things and keep consistency with all the technologies you’re using so it becomes less of an art and more of a science,” stated Boy.
Lab automation and controls empowered by sensing technology enable companies to take what is developed in a smaller form factor like a petri dish and more reliably and consistently scale up the product to the largest bioreactors.
“This becomes a plug and play process that becomes very easy and it falls in line with what the FDA is talking about with the PAT regulations…Also, single use is becoming a big thing and part of the reason is that it is removing the human element from the process. If it is single use you use it for that run and then throw it away and you start again with something that is GMP certified. You’re not sterilizing yourself or worrying about contamination because someone may have not sterilized properly. You’re also saving the time it takes to sterilize. Optical sensors are very inexpensive…you can use these for a run, throw them away, and use another for a fresh run,” added Boy.
“From a control design point of view, we like the fact that the sophisticated electronic parts are built into the control system, whereas the pH and DO targets are used once and are not expensive. We get to build a control system with sophisticated components that are reusable, but our customers don’t have too much money involved in what you might end up throwing out,” stated Ronchetti.
“People tend to mix up sensing and control. Sensing is not enough; it is telling you what the measurement is, what the pH is right now. This is the first, basic step for automation and optimization. The second step is control. You need to have not just the fact you can sense but that you can control that. The combination of the control systems from Lab Owl and SBI’s sensors is exactly that. That is what we try to bring to the industry. This is critical; it is the difference between knowing what’s happening and controlling what’s happening. When you can control you can optimize,” said Karnieli.
We want to take something that an artist knows how to do because he ‘feels’ the cell and make it autonomous,” he added.
When scientists and labs can sense and control, they can automate and that’s when cell culture and bioprocessing can become a more repeatable process with excellent, predictable quality control, which is one of the primary goals of the FDA’s PAT initiative.
Versatility and Ease of Integration is Critical to Lab Automation and Controls
The tissue engineering projects being conducted by the Advanced Regenerative Medicine Institute (ARMI) (Lab Owl and SBI are both members of ARMI) and the CAR T work being done by Adva Biotechnology are very different yet they both utilize Lab Owl and SBI’s optical sensors in their processes.
“A system like Lab Owl is a series of building blocks that measure things and have control loops. The ARMI system and the Adva system are very different, but the building blocks are very similar,” stated Ronchetti. The Lab Owl product is modular and is easily integrated into existing systems, whether they are brand new or refurbished.
“Lab Owl has built many control systems for labs and production facilities. When you design a lab your needs will change. The needs will change six months from now so it’s important to work with good vendors and tell them what you need today and what you’ll need in six months or a year from now. You have to put systems in place that are easily modifiable and are very programmable so that your function in the lab can change with your needs. You can work with industry experts like the people on this panel and tell them this is what I need now and I think this is what I’m going to need in the future so you don’t have an obsolete system on day one ,” added Ronchetti.
Adva’s Karnieli wrapped up the panel discussion by aptly summarizing what Lab Owl and SBI can do to advance more cell and gene therapy and regenerative medicines to the market: “The process is not the product, the product is the product. The first thing you have to do is know your product. When you know your product and you know your cells…then you can learn the process. Measure, look at the parameters, put sensors in and observe what’s happening. And then it’s very simple to mimic in an automated manner.”
”We’ve been doing a few projects together. We come with a process and Lab Owl knows how to build it. If you know your product, you learn your process. It is simple if you know what you’re doing and you work with people that are open, flexible and professional,” he added.
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