New Transformational Technology Removes the Variable of Air in BioPharma Manufacturing

Last April, InterPhex 2018 served as the backdrop for the introduction of LifeAire Systems to the biopharma industry. The conference enabled air purification leader, LifeAire Systems, to introduce their transformational technology to biopharma industry manufacturing professionals seeking solutions to address emerging trends like personalized medicine driving increased focus on scalable solutions with increased speed to market.

In addition to winning the InterPhex Pharmaceutical Processing Editor’s Choice Award 2018,
CEO and Founder Dr. Kathryn C. Worrilow, Ph.D., formed a panel of
industry experts to help drive the message of technology advancements
within the personalized medicine field, entitled “Emerging and Transformational Technologies in Personalized Medicine — A Paradigm Shift”, wherein she shared the genesys of the unique LifeAire System and its potential for biopharma manufacturing environments.

The Genesys of LifeAire’s Transformational Air Purification Technology

Speaking to the InterPhex 2018 audience of biopharma manufacturing professionals, Dr. Worrilow shared the following:

“As a former provider of In Vitro Fertilization, we began a process many years ago to remove the variable of ‘air’ in our facility. We thought we could do so in an ISO5 five cleanroom, but we couldn’t. We had excellent control of our non-viable particulates. But what we learned over a 10-year study was that low-level viable particulates and volatile organic compounds (VOCs), or chemical airborne pathogens, were extremely impactful to our process–extremely impactful to the human embryo, i.e. the living cell.”

“So once we understood and defined the metrics that were truly needed for the optimal living cell culture (which exceeded GMP and ISO guidelines) we sought to purchase an air purification system that would
deliver the air we now knew was necessary, and there wasn’t anything available.  The absence of a solution was personally and professional unacceptable as offering the highest level of patient care was paramount. The absence of a solution was also the genesis of LifeAire Systems.”

“The human embryo is one of your most sensitive living cells, but it is also similar to the cells with which you’re working in biopharma. Any living cell application – gene cell therapy, regenerative medicine, stem cell – the cells we worked with, as yours, have zero defense mechanisms to their environment. Your volatile organic compounds (VOCs) each have a partition coefficient – meaning that they’re either water soluble, oil soluble, or often biphasic – the partition coefficient, along with other metrics dictates if they will enter your growth media or the oil partition supporting your cells.  Either can occur in a fraction of a second. And once they’re present, they remain a permanent cellular threat. The VOCs are not going to go anywhere. They highly cytotoxic. They contribute to epigenetic variation—and its influence on the living cell.”



“We’re excited to share a very new–and I’ll use the word ‘transformational’–air purification technology. We refer to our technology as ‘transformational’ because of the metrics that defined it, and the metrics that it delivers. We actually guarantee the air that it delivers – below detection VOCs, below detection viables, and ISO5 non-viables. And it delivers such at 20-25 air changes per hour.”

“Carbon is going to adsorb certain biochemical families of VOCs. Potassium permanganate is going to oxidize others. But there are many highly cytotoxic VOCs that go right through both media. So our media is
targeted for all cytotoxic VOCs but it’s done so in five different stages. The capture model is not sufficient. There must be a kill model, which our solution employs.”

“This is a new technology. We’ve recently commercially launched, and Stanford, Mayo Clinic, Northwestern, Wake Forest, UConn, and other such clinical and scientific leaders are using the technology. By comprehensively removing the variable of ‘air’ beyond non-viable particulates, beyond GMP guidelines (and they’re all doing their processing differently) their clinical outcomes have increased by an average of 20 percentage points, which is about an overall 40 to 50 percent increase.”

The Unique Needs of Personalized Medicine

Mark Butler, President & Managing Director – Americas, IPS, added:

“Facilities are getting much smaller. They’re starting to look like a cleanroom lab
environment attached to blood treatment facility. They’re close to hospitals and cancer treatment centers. And they look very differently to the GMP  environments that we’re used to seeing. There are new technologies that will do this benchtop processing in a closed environment, but while they might be HEPA filtered, they’re not taking out the VOCs–which is what LifeAire does. As we start to scale down and build these smaller, flexible facilities, solutions like LifeAire are ideal because they fit very nicely into a pod environment which supports this trend.”

Maik Jornitz, President & CEO, G-CON Manufacturing, added:

“When you look at personalized medicine, it’s a very small volume. It’s a patient you’re dealing with, and when you’re dealing with a patient you need to make sure that you have the most robust containment. When it comes to volatiles in the air, contaminants are all over. They can be brought in by the human being. They can be brought in by clinical materials; for example, the wall panels or the laminate floor. So we have to be much more aware about that because these volatiles penetrate HEPA filters which are installed. We require to clean the air within a confined smaller, compact cleanroom system. We can do that with a
LifeAire System and then when the air is clean within that compact system we can pause the samples within an isolator.”

“One of our companies utilizes cancer cells from patients. They extract the cancer cells, bring them into an isolator and reconstitute them so your own body is fighting the cancer. So it’s a cancer vaccine product. Now this is an open process. If you do not have the LifeAire System and you bring the volatiles out, these cells will be influenced. And you don’t want to have that happen. So it’s very important that the containment of the samples, the processing of the sample as well as the air within that containment, has to be assured clean.”

Scalable with High Speed to Market

Speaking to scalability, Maik Jornitz, President & CEO, G-CON Manufacturing, continued:

“Typically when you scale up and your infrastructure–your HVAC system–is interconnected, you break the wall. And you want to build another processing space, you start interrupting the existing side. And that’s a reason to consider LifeAire. Because, with LifeAire you can create independent, autonomous cleanroom spaces which are highly containment units but also can run when you dock an additional space into that room. So when you start scaling out your capacity you don’t interrupt your existing processes.”

“The other part which I always like to see is cloning. When they have the capability to clone it and bring standardization on one particular cleanroom structure, then you don’t reinvent the wheel over and over
again. By cloning and copying it, you get scaling effects. It will be much faster with your delivery in future. To me, ‘scale out’ is way better than ‘scale up’.”