Germfree: Hitting the Road with a Flexible and Cost-Effective CGMP Mobile & Modular Manufacturing Solution

Jeff Serle (JS), Carol Houts (CH) and Kevin Kyle (KK) from Germfree discuss their novel and flexible approaches to solving logistical manufacturing challenges including: sustainability, capacity and expansion, ahead of the companies mobile laboratory East Coast road trip.

Could you tell us a little bit more about Germfree and your mobile laboratories?

KK: Germfree is a company that has been in business for 60 years. We started out as a company providing equipment to hospital pharmacies and later moved into biocontainment and biopharma. We leveraged our technological expertise gained through HEPA filtered equipment for both contamination control and biocontainment, coupled with our experience in manufacturing mobile laboratories for the military, to transition into the bioGO^TM GMP mobile cleanrooms that you see today.

What would you say are some of the key challenges that cell and gene therapy developers face when considering the complexities of delivering autologous cell therapies to patients, considering decentralised point-of-care delivery? who will need to be thinking about the scaling out processes to match their demand?

CH: I think ultimately the autologous cell therapy space is inherently risky and the logistics are extremely complicated. There are patient care requirements to be considered, which add a sense of urgency. For example, looking at the logistics of collecting a patients cells at a given time on a given day, it doesn’t necessarily work in a centralised model. In a decentralised model you can adjust for this. The mobile platform Germfree offers really helps to support that and reduce and the risk associated with logistical challenges.

JS: I think it’s important to point out the facility build times are typically 18–36 months or even more in today’s climate with supply chain issues, whereas mobile solutions can be up and running in matter of weeks. This allows manufacturers to jump into their clinical trials almost immediately, whilst their facility is being built. It also allows them to pivot quickly if changes are required to their process during the clinical trials.

CH: Clinical trials are extremely expensive. Providing capital upfront financing to build manufacturing capacity or using operational expenditures can really help provide some flexibility. As far as the financial models that are needed to really advance the development of a CAR-T therapy, for example, Germfree offers a leasing model that helps build on that flexibility. It helps you reduce capital expenditure and allows for some early, faster failure and then movement. A company can move on to what’s next in their platform, and it provides that great flexibility.

Could you speak more to how a mobile laboratory or ecosystem of mobile laboratories can solve some of these key issues?

KK: Mobile facilities are a cost effective, fast and flexible solution. The bioGO mobile platform supports the scale-out process by using standard proven GMP facility designs that are pre-commissioned and pre-qualified, thus significantly shortening the time to process readiness. This is going to be the main driver for both our clients and our patients.

JS: Flexibility is key. We’ve designed bioGO on a platform that allows the Germfree standard to fit multiple client process needs. This flexibility allows for one product to serve many process needs. For example, a grade C trailer space can transition into a grade B space to offer flexibility to the developer when the point of up-scaling is reached. We have also come up with a way to interconnect multiple trailers to develop interconnected module facilities.

CH: The processes that are most commonly being utilised for CAR-T and other cell therapy products are still very manual and involve open processing. Providing the availability of grade B space and a mobile platform reduces the background risk until close system technology advances further.

If we are to overcome the challenges that we have outlined already, where do you see the advanced therapies industry in perhaps 5–10 years-time?

CH: The industry is moving so fast that 5–10 years feels like a long time. Ultimately, allogeneic cell therapy processes are at the forefront of research and development. The FDA is beginning to embrace the idea that we may need both a decentralised model and a centralised model for delivering therapies to patients. If we look at decentralised models, they allow the industry to now democratise these therapies globally. I think we’re going to see a lot of advancement in that direction, maybe even sooner than 5–10 years’ time, now that the regulators are on board. The technology and equipment currently under development may allow for the processes required for cell-based therapies to become entirely closed. Something we here at Germfree are all looking forward to.

Are any current business models sustainable for this level of expansion or growth in the industry?

KK: The industry is preparing for this. We are seeing a massive amount of investiture into the business. I’m proud to be working with the many professionals we get to work with everyday, both those within team Germfree and our partners. I think that Germfree is definitely prepared and the mobile cleanrooms are going to be a key solution in overcoming many of the challenges the industry is facing

CH: I think the flexible manufacturing platform is a really substantial tool for helping the industry scale these therapies globally, and to be able to reach patients in a better way. The mission for everyone in this space is to work towards better patient access to these curative therapies.

Germfree is going to be in Miami ahead of a big road trip, could you tell me more about what that means and what we should be looking out for from you?

JH: Germfree was founded in Miami and this will be a great homecoming for ‘Team Germfree’. We will be bringing a fully operational mobile intelligent cell processing facility to the Phacilitate show floor. It’ll be a great kick-off to our road show that will see us bring the truck to key stakeholders across the country. We are really looking forward to this.

You can find out more about the Germfree truck and other exciting features that we have in store for Miami by visiting www.advancedtherapiesweek.phacilitate.com.

This feature was developed in partnership with  Germfree.