Animal models are an essential part of R&D within the life science sector in general, and in drug discovery in particular. However, as calls grow for a decrease in the exploitation of animals for medical research, new research tools are being developed to decrease the need for animal experimentation. At the forefront of this endeavour we find the innovative Swedish biotech company Fluicell.
Bringing a new drug to market is a challenging and costly process. The journey from drug discovery to market approval takes several years, even decades in some cases, of dedicated work and involves high levels of risk. In fact, statistically, only 1 in 5000 new compounds are approved as pharmaceutical drugs by regulatory agencies like the FDA in the US or EMA in the EU, and costs can easily run up to 2.6 BUSD according to the latest study by the Tufts Center for the Study of Drug Development. Read more about the challenges related to drug development here.
According to a report published in the National Academies Press, failures during the drug development process account for as much as 75 per cent of the R&D cost burden, and much of the costs come from failures during clinical trials. One of the reasons for the poor clinical outcomes is the inability to properly predict how an experimental drug molecule will behave in humans, and that is because of a lack of proper pre-clinical models that fully reflect the human biological system.To reduce the drug development costs, there is an urgent need for techniques that reduce the need for animal experimentation, thus enabling early strategic R&D planning that would require few requirements for regulatory approval.
A push for better experimental research models
In the pre-clinical world, there are currently two ways of shedding light on how a potential new drug will behave in the human body: in vitro cell cultures or in vivo animal models. Both have pros and cons; cell cultures are human cells, making them biologically relevant, however they lack the complexity of full-grown tissues or organs. Animal models, on the other hand, give us the biological complexity, but not the biological relevance of human cells. It is therefore not surprising that many drug trials fail when tested in humans.
Thus, alternative experimental models are not only desirable but also in acute demand as they would not only make drug discovery more cost-efficient but would also help address many of the ethical concerns connected to the use of animal models in medical research. In fact, there is a strong global push to reduce animal experimentation, and animal testing has already been banned in the EU for cosmetics and toiletries since 2013.
Fluicell’s Biopixlar is a step in the right direction
While it will probably take quite some time to fully replace animal models, researchers and biotech companies are quickly discovering innovative ways of at least reducing the need for animal experimentation. One such company is Fluicell, based in Mölndal, just outside Gothenburg. The biotech company specializes in developing technology that enables researchers to create detailed in vitro organ and tissue models with increased biological relevance compared to currently available methods.
Thanks to its latest addition to a comprehensive product portfolio, the 3-D bioprinter Biopixlar, the company is able to construct tissue models with single-cell precision, using human cells. This tool allows researchers to create detailed, multicellular models that emulate the functionality of the organ in question through precise recreation of its cellular architecture, addressing the lack of complexity of cell cultures that prevents replacement of animal testing in medical research.
New liver model with Biopixlar
Biopixlar is uniquely positioned to take on this challenge as no other technology on the market gives the user the same amount of control over cell positioning and tissue construction. Additionally, Biopixlar can be used to incorporate patient-derived material when building in vitro biological tissues, further increasing patient relevance, compared to conventional cell culture techniques.
As an initial step towards new types of in vitro tissue models, Fluicell has been developing a bioprinted liver model to address the need for better cell-based systems for drug screening and disease modelling purposes. The liver model was presented in a live webinar in May by Fluicell’s CSO Dr. Tatsiana Lobovkina, showcasing Biopixlar’s single-cell bioprinting capability. Fluicell is now developing this concept further to be able to provide researchers with a drug screening tool that can outperform comparable systems on the market.
The 3R principles for reducing animal research
A big part of the work around reducing the use of animals for research purposes follows the principles of the 3Rs (Replacement, Reduction and Refinement), which were developed in the late 1950s by scientists William Russell and Rex Burch after publishing their book titled The Principles of Humane Experimental Technique. Today, EU legislation governing animal experimentation (Directive 2010/63/EU) mandates that everyone who uses animals for scientific purposes shall implement the principles of the 3Rs in their work, further adding to the urgency of finding alternative methods that fulfil the requirements of medical research and drug development.
Among the 3R categories, finding tools that enable full replacement is the most sought after. There is consensus among researchers that no single technique is capable of providing full direct replacement; therefore, for now, the solution requires several techniques to work in tandem and that actors across many different fields need to work together to meet the need for alternative methods.
Fluicell participates in 3R events
In addition to developing innovative technology for more sustainable R&D, Fluicell is also very active when it comes to participating in events promoting the international ethical standards for cell and animal experimentation. Furthermore, the company is dedicated to promoting strong collaboration within the research community around the efforts to bring forward new technologies and methods to replace animal testing for research purposes.
As part of this ambition, the company has already participated in a 3R conference held in Stockholm in January of this year, Seminar day on modern methods replacing the need for animal experiments. Now, Fluicell is playing an active role in organising a panel discussion on the topic on in vitro methods to replace animal testing on October 2 as part of the Science Festival in Gothenburg. In addition to the company’s CEO, Victoire Viannay, the other panellists will be Kristina Fant, researcher at RISE and a member of the Swedish 3Rs Center, and Sofia Östman, head of Animal Science and Technologies at AstraZeneca. The panel discussion will be filmed and broadcasted online. The full program for the event was published yesterday and can be found here.
Furthermore, Fluicell will participate in a hands-on Research Workshop organised by the Swedish 3R Center focusing on replacement and in vitro methods. The workshop will take place in Lund on November 26 of this year, and it will feature practical demonstrations of different innovative in vitro tools as well as lectures focused on in vitro techniques aimed at replacing animal models. You can find the program here. Fluicell will be showing how 3D single-cell bioprinting can take in vitro models to the next level.
Looking forward to a more sustainable research environment
Overall, with the continuously rising drug development costs, and with the long times required to take a new drug to the market, the need for a new experimental system cannot be overstated. While in vitro replacement systems are all very much in their infancy and there is still a long way to go before a large-scale replacement of animal testing for scientific purposes, companies like Fluicell are providing innovative technology like 3-D bioprinting that can bring us closer to a more sustainable R&D environment. BioStock looks forward to following the company’s journey in pursuit of this goal.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.