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Publication: Incorporating New Approach Methodologies into Regulatory Nonclinical Pharmaceutical Safety Assessment

Authors: Jan Turner, Pandora Pound, Carla Owen, Isobel Hutchinson, Marina Hop, David Y. S. Chau, Lady V. Barrios Silva, Mike Coleman, Audrey Dubourg, Lorna W Harries, Victoria Hutter, J. Gerry Kenna, Volker M. Lauschke, Winfried Neuhaus, Clive Roper, Paul B. Watkins, Jonathan Welch, Laura Rego Alvarez and Katy Taylor

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We work hard at ImmuONE to provide quality products and testing services for clientele all around the world. Our innovative in vitro solutions help consumers by providing relevant and reliable endpoints to support the decision-making process and improve risk assessment approaches.  The therapeutics, consumer products, and chemical industries are just a few examples. Our clients can work with us regardless of location, no distance is too far. So, the question is, how do we do it?

Taking the stress out of our work

Working hand in hand with our logistics partner, YSDS, is a game changer. Just because a business is not local, does not mean we can’t provide outstanding service. Forming an alliance with a professional logistics team has proven to be advantageous for our customers. Our study proposals now include shipping costs, removing all the tedious admin work required when sending test items, compounds, or biological samples.  We agree a collection date with our client and that’s it! The shipment is treated with care and consideration, without increasing their workload. Working with YSDS allows both parties unprecedented improvements in shipping efficiency without compromising on quality or adding to costs. 

Expert solution to a sensitive problem 

The models we prepare include specialised, sensitive cells. To accurately represent human physiology, the cells need to be viable outside of the body… therefore they have special requirements. These include being temperature specific, stored carefully, handled appropriately, and transported within a certain time frame. 

Delivering our services to the world

Shipping such biological and chemical items outside the UK presents issues and delays. This is where YSDS have also added value; a professional and experienced logistics team, qualified for the movement of chemicals and biological samples globally. They offer temperature- sensitive logistics monitored throughout the journey, ensuring that immediate action can be taken if there is the slightest deviation. Their experts plan the safest routes and provide risk assessments; with the ability to intervene if they see any potential delays on the horizon. The high level of service, use of the latest shipping technology, and detailed planning have proven to be advantageous. This would be hugely time consuming for both ImmuONE and our clients, but ultimately it is crucial to success.

Meeting the standards our clients deserve

Just as our products are developed carefully by expert scientists, so our logistics must match this. YSDS logistics solutions are GDP-certified and follow ISO 9001 standards. Compromised products can cause more harm than good when used for assessment, so it is crucial to invest in premium logistics methods. The attention our products receive from YSDS ensures that the quality of our products is not impacted by the risks of shipping, or the burden of never-ending paperwork, giving our team more time to work on new innovative products. 

In summary 

Most importantly, the relationship with YSDS makes the process seamless, both for us and our clients, ensuring that we all remain informed, every step of the way. (1)

Catching up with 21st century practices

Removing all animal derived products from in vitro cell culture.

Foetal Bovine Serum (FBS) is a highly utilised serum supplement for biomedical research and in vitro cell culture. It has been considered the gold standard for many years due to its relatively low cost and plethora of data showing the simple fact that it works. However, despite being the “go to” method for culturing eukaryotic cells, it doesn’t come without its flaws, namely incomplete protein profiles and inconsistent batches, since manufacturers are not required to disclose such product information.

It is easy to assume that FBS is just a serum, but recent proteomic and metabolomic studies reveal approximately 1,800 proteins and more than 4,000 metabolites are present which varies from batch to batch affecting experimental outcomes. For example, a higher or varying concentrations of signalling molecules such as Transforming Growth Factor (TGF) and Insulin- Like Growth Factor (IGF) can adversely impact functionality and activation of many cells, creating further uncertainty and variability in biomedical testing (Ferneyhough, 2015).

FBS contains a variety of proteins, lipids and hormones with many functions that can alter a cells in culture. A wide range of studies have shown that genetic make-up and environmental factors can affect an organism; therefore, factors such as diet, welfare, and the timing of the sacrifice of the cows or foetuses, as well as their genetics and biochemistry, can affect their serum characteristics. As a result, in vitro assessments may be difficult to reproduce, and produce misleading data, leading to uninformed decisions being made for potential test compounds.

Applied to the 2 million bovine foetuses killed annually to produce approximately 800,000 litres of FBS (Gstraunthaler, Lindl & van der Valk, 2013) Today, we consider not only the ethical use of animals in the chemical testing industry, but also poorly sustainable harvesting FBS is. For these reasons, researchers are actively seeking to develop a more reliable, reproducible, and sustainable, innovative growth medium for cells in culture.

My research at ImmuONE is focused on developing in vitro toxicology models that are 100% animal-free. The objective is to culture cells with the complete absence of animal products or derivatives of any kind. Throughout the stages of cell culturing, called passaging, we repeatedly test our immune models in a chemically defined medium, resulting in a completely characterised cell profile and a benchmark baseline for other researchers to compare their results against.

Development of serum-free media is time-consuming and can be extremely challenging, as it must include the necessary constituents to ensure cell culture and adaption to a chemically

defined media are successful. However, to truly understand any biological system being investigated, reliability and reproducibility are of the utmost importance, especially in biomedical research.

Following this study, our goal is to completely develop our macrophage models with a “vegan” alternative, and demonstrate to a large audience the possibility and subsequent benefits of culturing cells in animal-free media.

ImmuONE will exhibit this work at the Animal-Free Research Science Conference in Spring 2022.

Danny Johnson – Junior Scientist


Ferneyhough D.G. (2015) Cell Culture Dish. Achieving control and reproducibility of cell culture by eliminating serum. reproducibility-of-cell-culture-by-eliminating-serum/

Gstraunthaler, G., Lindl, T., & van der Valk, J. (2013). A plea to reduce or replace fetal bovine serum in cell culture media. Cytotechnology, 65(5), 791-793. doi: 10.1007/s10616-013-9633- 8

Van der Valk, J., Mellor, D., Brands, R., Fischer, R., Gruber, F., & Gstraunthaler, G. et al. (2004). The humane collection of fetal bovine serum and possibilities for serum-free cell and tissue culture. Toxicology In Vitro, 18(1), 1-12. doi: 10.1016/j.tiv.2003.08.009 (1)

CRACK IT Challenge 36: Winners Phase 2

Following successful completion on the phase 1 challenge awarded to ImmuONE by the NC3Rs, we were announced as the winners for the phase 2 challenge in Jan 2022. Sponsored by Unilever and AstraZeneca the project aims to establish and develop in vitro OECD test guideline assays; free from animal-derived products and demonstrate their equivalence and superiority to current strategies. Once optimised, these technologies will be progress to a commercially ready, human relevant, animal-free bioassays with the view to gaining regulatory acceptance. (14)

CRACK IT Challenge 36: Animal-free in vitro

We are excited to announce that ImmuONE was awarded funding to carry out the six-month proof-of-concept studies in Phase 1 of this year’s CRACK IT Challenges competition organised by the NC3Rs. Sponsored by Unilever and AstraZeneca, this challenge aims to adapt established OECD test guidelines for in vitro assays so that they are free from animal-derived products to improve human relevance and reproducibility and help drive the uptake of animal-free reagents.

Dr Victoria Hutter, CSO at ImmuONE is leading a multi-disciplinary consortium including PAN Biotech and the University of Oxford to answer this challenge. The team combines expertise in serum replacement, in vitro innovations and pre-clinical assessment to develop these solutions into marketable products and services that will have a significant impact on the 3Rs across the bioscience sector.

“It’s wonderful to be working with such a skilled and focussed team to address this Challenge,” says Victoria. “The NC3Rs, Unilever and AstraZeneca have put forward a very pertinent Challenge in the bioscience industry and we’ve put together a team that spans the breadth of expertise from innovators to end users to address it. As a result, we hope the benefits of entirely animal-product free approaches will be realised across the sector.”

One of the ultimate goals of the full Challenge is to deliver adapted OECD test guideline protocols which are free from animal-derived products and can be transferred to other laboratories to facilitate industry uptake.

“Whilst animal-free alternatives for cell culture and biological assessment exist, unfortunately their uptake by the scientific community has been slow,” says Victoria. “We aim to change this and demonstrate that completely animal product-free alternatives are possible and equivalent or better to standard animal product-containing reagents.” (15)

CASE STUDY: ImmuONE Making Each Breath Safer

Our co-founder Abigail Martin spoke with Set Squared about her journey from PhD student to building ImmuONE. This case study provides an outline of how ImmuONE was started and our expertise in human in vitro cell culture solutions for safety assessment. We take 23,000 breaths every day and the products we are developing help make those breaths safer for our bodies. Investment from ICURe was the first step in our journey and led to the discovery of how our products could make an impact within the biotech market and to various industries. Read more of our journey by clicking on the image below. 

Set Squared is a unique enterprise partnership and collaboration between the UK’s leading research universities of Bath, Bristol Exeter, Southampton, and Surrey, who support projects and help turn these into thriving businesses. (16)

Has 2020 influenced the transition to animal-free testing alternatives?

The year 2020 will not be forgotten in a hurry. It’s been tough for businesses in all sectors since the beginning of the global pandemic, which has transformed the way we interact socially and professionally. If that wasn’t enough to be dealing with, Brexit is edging ever closer, which impacts the regulatory frameworks for all areas of business. What a year we picked to establish ImmuONE Ltd, bringing our innovative in vitro inhaled safety assessment products and services to market.

How will the major events of 2020 shape the future of animal-free chemical and product safety testing in the UK? 

1. COVID-19

Lessons learnt from the animal-free safety assessment of cosmetics over the past decade have supported other industries in the move away from animal assessments in other industries. The rapid progression of COVID-19 vaccine trials in humans has in part been attributed to the availability of alternative in vitro and in silico tools, reducing the need for lengthy animal studies. There is every reason to adopt this approach wider within the pharmaceutical and chemical sectors. After all, 95 out of every 100 drugs that test safe and effective in animals go on to fail in human clinical trials. With the increasing demand for bringing products safety to market in a more timely and cost-effective way, the necessity for more human-relevant studies has never been greater. Perhaps this will spur the wider uptake of human in vitro cell culture methods and expand innovation in this field.

2. EU’s Chemicals Strategy

As part of the European Green Deal, the new European Chemicals Strategy for Sustainability is intended as a first step towards a toxic-free environment. The strategy highlights the need to develop multidisciplinary research and innovations for in vitro methodologies and data analysis capabilities to support the move away from animal testing. However, it has been criticised that the strategy lacks clear goals for phasing out animal testing and promotion of alternative methods. The unveiling of the strategy in October generated mixed reactions as to whether it would support the reduction of animal studies or increase the reliance on animal testing in chemicals safety assessment.

3. Brexit

The good news is that the UK government have confirmed the key principals of the EU regulation for the Registration, Evaluation, Authorisation or Restriction of Chemicals (REACH) into UK law which will be known as ‘UK REACH’ from 1st January 2021. This runs the risk of substantial repetition of both in vivo and in vitro studies for application under the UK REACH framework. However, there is no commitment to align with EU REACH regulation in the future.

The UK remains a global leader in the movement to replace animal testing. The reduction and replacement of animals in safety testing is lobbied by diverse range of institutions in the UK including charities (FRAME, Animal Free Research-UK, Lord Downing Trust), the commercial sector (Unilever, Lush, The Body Shop), scientific-commercial alliances (Human Relevant Science) and scientific organisations (NC3Rs). With this growing national support, perhaps Brexit could provide the catalyst for the UK to extend an animal-free approach to safety assessment beyond the cosmetics industry.

Outlook for 2021

As we bid farewell to the personal, societal and economic challenges of 2020, there may be some consolation that achieving animal-free safety assessment in all industries may be closer than we thought.