Home 9 Product Design 9 Getting from Lab to Market: The Ingenious Story of 3D BioFibR

Getting from Lab to Market: The Ingenious Story of 3D BioFibR

3D Bio fiber Tissue Engineering Services

Back in 1997, the public reaction upon first seeing the Vacanti Mouse (the laboratory mouse who appeared to have an ear grown on its back) was a mix of shock and fascination. The striking image spawned several concerning, yet rather ill-informed protests. But once the dust settled, the experiment conducted by Dr. Charles Vacanti had successfully proved the point.  

The tissue engineer and anesthesiologist had not set out to actually grow a human ear (it was actually just tissue shaped as an ear), but rather demonstrate the possibility of creating a complex, three-dimensional structure from living cells using a biodegradable scaffold. 

Today, nearly 30 years later, we are still a long way from growing full-fledged complex organs, but simpler tissues like cartilage and skin are now approved tissue engineering solutions built upon the biological scaffold principle. 

Trauma, disease, and congenital defects are the primary causes for tissue damage and loss. And due to the unfortunate fact that we humans cannot regrow our tissue as the salamander re-grows its tail, we look towards the incredible discipline of tissue engineering to help in our regenerative shortcomings. 

Around the globe, ingenious and inspired scientists are addressing this issue by cultivating tissue in cell culture labs, examining ways to replicate human tissue for use in further R&D (research and development) and therapeutic commercial applications. There currently exists decellurized tissues that work well in certain surgical efforts, but a tunable and customized tissue matrix for different applications is still urgently needed. 

medical device engineering with Enginuity's product engineering team

A Secure Foundation 

If you removed every drop of water from your body, what would remain is about 30% collagen. This protein makes up the main structural elements of your body. Your tissues may be made of cells, but they’re actually built upon something called an ‘extracellular matrix’, and that matrix is made of collagen.   

This collagen matrix serves as a scaffolding on which to create tissue. 3DBioFibR’s Dr. John Frampton and his team have developed a stunning method of manufacturing these protein fibers into the exact specification on which to grow the desired cell/tissue, called “Dry Spinning”. 

Prior to Dr Frampton’s innovation, Wet-spinning and Electrospinning were the common methods of fabrication of the scaffolding matrix. However, these techniques have their shortcomings, inconsistent fiber diameter and scalability being the most pronounced. For these reasons, the industry has focused more on decellularized tissues and lyophilized collagen sponges. 

Responding to this gap in the market, Dr Frampton’s team, which included collaborator Laurent Kreplak and then Master’s student Gurkaran Chowdhry, uncovered a process in which addressed these issues. The new fiber creation technique culminated in the founding of 3DBioFibR, a biotech company to change the way tissue engineering is accomplished. The innovative biotech company is part of a recent generation of startups and scale-ups that are taking solid academic research and developing it into a highly commodifiable and scalable product.   

And the value proposition is brilliant. 

But biotech is risky business. Securing seed funding, poor results, legislative hurdles, multi-agency and territorial approval and getting scooped (someone nefariously stealing your IP), are evergreen challenges that hinder getting potentially lifesaving advancements to market. 

Enter experienced biotech entrepreneur, Kevin Sullivan. 

“What I liked about what John [Frampton] had done is he had come up with a scalable way of inducing the formation of a better version of a key building block of all tissues”, explains Sullivan. 

“If you can make something that is best-in-class and is fundamental to the whole emerging field of building tissues, then you’ve got something very special. There was a decent amount of data that kind of pointed in that direction, and that was the bet that I made. “ The bet Sullivan made was to become CEO of the promising company.

Commercialisation and Scaling Strategy 

Having already helmed four bio tech companies and taking one of them public, Sullivan is well versed in navigating Canada’s challenging “IP to market” landscape.  

Sullivan continues, “[Frampton] had some key patents filed on the fundamentals of this new collagen spinning technology. So a lot of the key pieces that needed to be in place to build a business were there. Those patents have subsequently issued in the U.S., and three new patents filed since, giving us a strong IP foundation.”  

Commercialisation was the next step. 

Securing capital for scaleup is not for the faint of heart. Public funding and resources for both R&D and commercialisation are at a competitive premium and unfortunately can ebb and flow with political tides. But Sullivan has been here before.  

How do I commercialise my research?

Here are 5 key steps to consider when commercialising your biotech research.

  1. Assess commercial potential – understand the market demand, competition, and potential barriers to entry.
  2. Protect Intellectual Property – ensure you’ve secured your IP rights in every jurisdiction.
  3. Secure Funding – explore various funding sources, including venture capital, government grants, and angel investors.
  4. Build a strong team – Assemble a team with expertise in biotechnology, business development, regulatory affairs, and marketing.
  5. Develop a bulletproof Go-to-Market strategy – Focus on your strategy. This includes marketing, sales, distribution, and post-market surveillance. Tailor your strategy to your target market and customer needs.

For help in any of these areas, make an appointment with us today.

In the summer of 2023, the burgeoning bio tech firm closed $2.6M in equity financing from investors, and the following January closed an additional $550K from Next Generation Manufacturing Canada (NGEN). Had it not been for Sullivan’s expertise in raising capital, the innovative product may not have come to fruition and would still be a long way from being commercially available.  At every stage of the journey Kevin has converted his experience and knowledge into capital investment from the private sector. This investment has allowed Sullivan and his team to build a facility in which to produce commercial quantities of the collagen scaffold.  

Biotech Commercialization

A Shared Biology 

An integral part of the Lab to Market ecosystem is building the right partnerships. The 3DBioFibr team knew they had something special and looked to creative engineering firm Enginuity to design and build a system that could meet the forthcoming commercial demand for their products. 

The initial incarnation of the fiber spinning tool was quite literally two paddles that when pulled in opposing directions would produce the collagen fibers, not unlike the glue between your fingers as you pull them apart. Then student, Gurkaran Chowdhry had done his master’s degree on what was happening at the physics level of this process, and now it was time to get automated. 

Dr Frampton, Chowdhry and Sullivan brought this idea to  Enginuity’s Product Development team and together developed what would eventually come to be known as the FibRCatR. They then took the design over to the Enginuity’s internal mechanical team and constructed an automated gantry-style machine that would allow the collagen scaffolding to be built like a log cabin from the bottom up.  

Much like a weaving loom, the Enginuity-built machine, which leveraged their Automation and Robotics capabilities, can pull multiple collagen strands at once – exponentially increasing production to commercial levels while maintain consistency. In fact, 3DBF is able to target fibers that are between 1-5 microns in diameter and is the only scalable spinning process that can hit these diameters, which match the diameters of collagen fibers in the body.  

“The diameter control is a big deal” explains Sullivan. “A cell that is 20um in diameter, and evolved to grow on collagen fibers that are 1-5um in diameter, just behaves in a more natural way if you give it a collagen fiber that looks more like the collagen that it evolved to live on. 

Additionally, the patented spinning process is at least 3600X more efficient than either Wetspinning or Electrospinning. And since the manufacturing method is additive, the technology allows for the tuning of the thickness, the porosity, and the architecture of the scaffolds that are built.  Furthermore, biologically active molecules can be introduced into the spinning solution during the spinning process where they get trapped within the fibers and can then affect the cells growing on the scaffolds in ways that are therapeutically helpful.  Each one of these features alone would make for an incredibly unique valuable proposition, but combined, they establish the product as an absolute game changer. 

Pairing scalability and tunability, with the ability to control diameters and dope in biologically active molecules, makes for a very customizable manufacturing process. This poises the company is incredibly well to fill the voids in both the tissue engineering and regenerative medicine markets.  

And people are noticing.  

Having recently signed clinical partnerships with companies such as Australian medical device company RENERVE, 3DBioFibR is securely establishing itself as the foremost resource in the advancing field of tissue engineering.  

What do Biomedical Engineering Services Encompass?

Bio medical engineering services include the following activities; design, development testing and manufacturing. It is imperative that when bringing innovative concepts to market they must be safe, effective, and compliant with regulatory standards.

We engineers must also adhere to the pillar of the Hippocratic oath, namely “do no harm”.

Check out our sister company FIVA here.

It is rare when such an advancement in the life sciences successfully finds itself combining research, therapeutic and commercial pursuits in concurrence, but this is exactly what 3DBioFibR has done. By mixing equal parts academic excellence, public and private funding, and a healthy heaping of trust in a creative engineering partner like Enginuity, there is little doubt of the success that sits just over the horizon for the biotech firm. 

There is much risk inherent to biotech commercialisation, it is not for the faint of heart. But should your heart break, we know where the scaffolding will be made to fix it.  

Some Great Examples of biomedical commercialisation

Medtronic – Continuous Glucose Monitoring (CGM) Systems: Medtronic has been a leader in the development and commercialization of Continuous Glucose Monitoring (CGM) systems for diabetes management. Their devices provide real-time glucose readings, allowing patients to monitor their blood sugar levels continuously and manage their condition more effectively. CGM systems represent a significant advancement in diabetes care, improving the quality of life for millions of people worldwide.

ABK BioMedical – is a company that specializes in the research, development, and commercialization of innovative medical devices in the field of interventional radiology, specifically focusing on embolotherapy solutions. Embolotherapy is a minimally invasive procedure used to block blood flow to certain areas of the body, typically to treat tumors or to manage other conditions such as uterine fibroids. Enginuity helped develop the delivery device for their unique radio-opaque Easi-Vue inert embolization microspheres.

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