At the end of August, cleanroom design and build expert Germfree announced a partnership with the nonprofit Caring Cross.
Caring Cross is focused on accelerating the development of advanced medicines and ensuring patient access to these transformative therapies. This partnership will focus on a sector that Germfree has a lot of experience and expertise in cell and gene therapy.
At the end of August, cleanroom design and build expert Germfree announced a partnership with the nonprofit Caring Cross
The new partnership is by no means the first in Germfree’s repertoire, and Cleanroom Technology spoke to the mobile cleanroom and biocontainment expert’s CEO Kevin Kyle to discuss the company’s future plans.
He speaks about pushing forward the decentralised model of manufacturing, creating a new QMS/BMS/EMS innovation, and how the company aims to transform access to cell and gene therapies (CGTs), as well as other therapies.
Kyle has been CEO of Germfree since February 2021, but has been at the company since 2017, seeing a great time of growth.
A decentralised system
The Germfree-Caring Cross collaboration is set to make cellular gene therapies more available to patients by creating a decentralised, point-of-care manufacturing model. This model will combine Germfree’s mobile cleanroom units with Caring Cross’s innovative manufacturing technologies and pipeline of cellular gene therapy products.
Simply put, a decentralised system is when an organisation distributes planning and core activities away from a central location or group. Delegating these tasks to smaller satellite factions.
The Germfree-Caring Cross collaboration is set to make cellular gene therapies more available to patients by creating a decentralised, point-of-care manufacturing model
Kyle explains that decentralisation is part and parcel of making cell and gene therapies. This is because the starter material for these medicines is the patient, making the hospital location a logistical necessity.
This means processing within a controlled environment is going to be required at the hospital itself.
"[We need to] figure out how to decentralise but have a quality mechanism whereby you can watch several nodes and ensure quality and compliance always, but also be closer to the patient,” Kyle says. “I think that is where we're going to go in the kind of short to medium term."
Is mobile the answer?
The CEO is also a big believer that his fleet of 20 mobile cleanrooms can help with this decentralised model. This foundational part of the company’s business is a real good fit for the decentralised model, especially for hospitals.
Kyle explains that about seven years ago the company invested heavily into the hospital pharmacy space with USP 797 and 800 compliant cleanrooms.
The CEO is also a big believer that his fleet of 20 mobile cleanrooms can help with this decentralised model
“[This] allows our hospital clients to basically move into the mobile facility, keep their operations going, and keep serving their patients while they do renovations inside the hospital,” he details.
Examining how this investment has paid off, Kyle estimates that in this time, the 20 unit fleet has over 100 deployments taking place in more than half of the states in the US.
The partnership model
This partnership with Caring Cross and putting their technology into a mobile cleanroom unit is a great representation of how Germfree builds its business model.
In the beginning, the company was building equipment like laminar flow cabinets and biosafety cabinets, and later moved more into isolation and higher level biosafety cabinets. From there, the team moved into cleanrooms and biocontainment suites. Kyle believes it was this foundational expertise in containment and ability to manufacture the equipment in-house along with the facility, that was a true differentiator.
This familiarity with biocontainment is also helping Germfree in the world of CGTs as viral vectors, a major delivery mechanism for these therapeutics, require a strict handling process.
This partnership with Caring Cross and putting their technology into a mobile cleanroom unit is a great representation of how Germfree builds its business model
However, many would say that taking this very specific facility expertise and combining it with specific application expertise is a defining feature of Germfree. The company is very picky when it comes to choosing collaborators. “When we do partnerships we do them very mindfully,” Kyle says. “When you pick partners you wanna pick really good ones, not just experts.”
This has resulted in collaborations across many sectors. Partnerships with companies like Ardmac, Orgenesis, AST, and Title21 Health Solution.
These partnerships have produced cleanroom products for biotech, CGT, and aseptic fill-finish applications.
The latest partnership
Using the Caring Cross partnership as an example, this project targets CAR-T therapy manufacturing and builds on three years of preparation, including a pilot project with Brazil’s Fundação Oswaldo Cruz (Fiocruz) to launch local CAR-T manufacturing in 2025.
The company has around 25 launches and innovations it is working on at the moment
Germfree will lead the facility innovation, providing advanced hardware and digital platforms to ensure robust quality control. Meanwhile, Caring Cross will develop the therapeutic product, provide the workflows and manufacturing protocols, and train doctors and healthcare organisations in the production of these therapies.
The success and productivity of these partnerships has cemented this strategy into Germfree’s business model for the benefit of both them and the client.
Innovating new products
As seen with its many new partnerships, innovation is very important to Germfree, and is a part of the job that CEO Kyle particularly enjoys.
When asked to estimate how many launches and innovations the company is working on at one time, Kyle says he reckons around 25.
We’ve got two different partnerships going on right now that are proving this out as we speak
He explains though that these are products in many different stages, and that he and the team are quite rigid in how they let everything filter down the development process to make sure they are worth it.
“If you throw 25 things in a funnel, you can't, you can't work on them all at once. So we're much more disciplined when we start to get from ‘this is a great idea’ to 'this one is a reality’,” he shares.
A landmark new QMS product
Once such product is the company’s efforts to work with partners on the quality management system (QMS), building management system (BMS), and environmental monitoring system (EMS) side.
“We’re trying to pick best in class companies to work with because ultimately these solutions are needed by the people working in cleanrooms,” Kyle stresses. “ Whether that be hospital pharmacy, cleanrooms or biopharmaceutical cleanrooms or cell and gene therapy cleanrooms, there isn't a single company that has all of those technologies wrapped into one.”
All of these types of cleanrooms have one issue at their heart, patient safety. Therefore compliance is constantly in focus, and QMS, BMS, and EMS are a big part of that.
I think it's a little early to announce some of this just yet, but it's well down the path
Whereas a decentralised model is the future of manufacturing, Kyle thinks that a big topic of discussion going forward is going to be a centralised QMS that can then be distributed. “I think we've gotten great solutions when it comes to the BMS and the EMS side of things, but that decentralised QMS, I think is a massive topic that will all be glad to invest in,” he says.
The CEO reveals that the company has two different partnerships going on right now that are trying to prove this out. He goes on to explain these solutions are in use and have delivered drug products to patients in the last year. "I think it's a little early to announce some of this just yet, but it's well down the path and these are things we've been working on for multiple years,” he explains.
Just before moving on from the new product, the CEO of the 200-person-strong business makes the insightful but often ignored fact that you have to make sure things are right before you go before you go too big.
Compliance
Germfree has made its intentions clear that they are trying to take the cleanroom and make it into a product. Bringing cost efficiencies and quality increases.
“We're trying to move it all down the product path but it takes time and there are some complexities and I think the complexities go back to why when you pick partners you wanna pick really good ones, not just experts,” Kyle says.
Germfree has made its intentions clear that they are trying to take the cleanroom and make it into a product. Bringing cost efficiencies and quality increases
It is this wealth of experts that can help navigate the common challenge which is compliance. Regulations can be a minefield due to the different types and their application.
Kyle says they he thinks the harmonisation across the standards at a high level is quite good, though he does add that “plenty of people in industry would argue that point with me”. He thinks the real challenge comes from interpretation.
“What I think we could do better on as societies overall is making regulations more prescriptive such that they give very direct guidance on exactly what should be done and take away the interpretation,” Kyle says. "I think there's a lot of time spent on interpretation of regulation rather than on just getting to the engineered solution that delivers compliance.”
A home for a toxin
“The most complicated application we've done, we did a couple of years ago. We delivered this project and it has been commissioned. It was for a toxin that needed to be done in BSL3 level biocontainment. But it also needed to be done in cGMP compliance."
"So you’re basically trying to put all of the active ingredient under negative pressure to protect the operators from the product. But at the same time, you need to maintain aseptic conditions which is normally a positive pressure environment. It was tricky. But if I’m honest my team kind of salivates for those types of projects and challenges."
