Current regulatory frameworks and how the future of regulation may impact both industry and the future commercialization of academic research.

Panel discussion clip, provided by CARMA

The CARMA (Cellular AgRiculture MAnufacturing) Hub is an EPSRC-funded transdisciplinary seven-year project focused on developing novel approaches to making food products. Their vision is for a just transition to environmentally, economically, and socially sustainable food systems. Their mission is the integration of transdisciplinary responsible approaches, for novel cellular agriculture tools and technologies, into current food systems, to deliver sustainable food manufacturing in the UK and beyond. Led by the University of Bath, this multidisciplinary project also includes colleagues from the University of Birmingham, University of Aberystwyth, University College London and the Royal Agricultural University, as well as a range of industrial partners.

CARMA held it’s first in person meeting on the 17th September 2024, at the Guildhall in Bath, UK, bringing together researchers and industry representatives to share their knowledge and experiences. The day was filled with interactive discussions, networking opportunities, and innovative ideas in the field of cellular agriculture manufacturing.

The panel discussion offered perspectives from companies working to bring cultivated meat, fish, fat and dairy to consumers. The aim was to inspire early career researchers and demystify research in this industry to highlight and encourage transitions in both directions between academia and industry. The ultimate goal was to aid in shortening the timeframe to impact on sustainability and science and increase the success of the CARMA project by widening the consultative network.

The panel discussion focused on key issues in the cultured meat sector; the current regulatory framework, cell and growth factor selection and academic-industrial relationships.

This blog focuses on the current regulatory frameworks and how the future of regulation may impact both industry and the future commercialization of academic research. Read the follow up blogs for more insights.

The panel was led by Catherine Elton, CEO of Qkine who was joined by Jon Dempsey, expert in biological medicines process development and regulation, Yennifer Cortes Araya, Head of Cultivated R&D at Uncommon and Prithvi Kodialbail, Chief Technology Officer at Extracellular.

The regulatory landscape is rapidly evolving, what do you think is going to be the biggest impact for CARMA?

The regulatory landscape for cellular agriculture is rapidly evolving and although those working in industry will have this at the front of their minds, it’s something that researchers in academia may not always consider. As it’s changing so quickly and varies greatly from county to county it can be hard to keep up with changes.

‘We can simplify regulation to two key aspects, firstly the source of your cell line, its history and testing. Testing is not enough so its history has to be documented. Secondly food safety, for example if using stem cells there are compounds added to stem cells to keep their pluripotency. These can’t be added to food because they are pharmaceuticals, we don’t want to give people drugs they don’t need, and they may also not have toxicology profile, so we don’t know what the safe limit is.’ Jon Dempsey.

Regulatory bodies are also considering public opinion as they set standards for the cellular agriculture industry. Public opinion on novel alternative protein sources will also dictate the success and commercialization of these products.

‘Keep in mind the perspective of the public and the influence of consumer perception. People often fear what they’re unfamiliar with, so in any area of research or development, it’s essential to consider what’s being added to food, even distinguishing between research-only and food-grade ingredients. Ultimately, we need to convince people to eat these products and feel comfortable eating them. While scientists may understand that some reagents aren’t harmful, explaining this clearly to the public is a different challenge. Both industry and academics need to think about this proactively and start engaging in conversations, as this public perception is also a regulatory consideration for the industry. .’ Yennifer Cortes Araya.

The regulation of such novel food products is a complicated process, regulators need to ensure that food products introduced into the consumer market are safe long-term. Regulatory bodies need expert help to make these decisions, and those working in the cultivated meat sector are experts and know best what has been developed and the possible risks. Sharing knowledge and background with regulatory bodies will help them to successfully and safely regulate novel protein sources.

‘Regulation is a feedback loop. The ability to work with people and feed back to regulatory bodies any advances is key to addressing food safety and quality.’ Prithvi Kodialbail.

The regulatory landscape is rapidly evolving, what do you think is going to be the biggest impact for CARMA?

The regulatory landscape for cellular agriculture is rapidly evolving and although those working in industry will have this at the front of their minds, it’s something that researchers in academia may not always consider. As it’s changing so quickly and varies greatly from county to county it can be hard to keep up with changes.

‘We can simplify regulation to two key aspects, firstly the source of your cell line, its history and testing. Testing is not enough so its history has to be documented. Secondly food safety, for example if using stem cells there are compounds added to stem cells to keep their pluripotency. These can’t be added to food because they are pharmaceuticals, we don’t want to give people drugs they don’t need, and they may also not have toxicology profile, so we don’t know what the safe limit is.’ Jon Dempsey.

Regulatory bodies are also considering public opinion as they set standards for the cellular agriculture industry. Public opinion on novel alternative protein sources will also dictate the success and commercialization of these products.

‘Keep in mind the perspective of the public and the influence of consumer perception. People often fear what they’re unfamiliar with, so in any area of research or development, it’s essential to consider what’s being added to food, even distinguishing between research-only and food-grade ingredients. Ultimately, we need to convince people to eat these products and feel comfortable eating them. While scientists may understand that some reagents aren’t harmful, explaining this clearly to the public is a different challenge. Both industry and academics need to think about this proactively and start engaging in conversations, as this public perception is also a regulatory consideration for the industry. .’ Yennifer Cortes Araya.

The regulation of such novel food products is a complicated process, regulators need to ensure that food products introduced into the consumer market are safe long-term. Regulatory bodies need expert help to make these decisions, and those working in the cultivated meat sector are experts and know best what has been developed and the possible risks. Sharing knowledge and background with regulatory bodies will help them to successfully and safely regulate novel protein sources.

‘Regulation is a feedback loop. The ability to work with people and feed back to regulatory bodies any advances is key to addressing food safety and quality.’ Prithvi Kodialbail.

Do you think long regulatory processes in different countries will delay and impact the development of these products? Will they be banned in the UK?

The regulatory landscape for new products is complicated as each country and potentially each state in the USA has different regulatory bodies. In the UK the food standards agency (FSA) regulates novel food products, it sets very high standards and is being highly proactive in industry and international engagement. Cultivated meat is a new industry and they want to ensure it is safe and accepted by consumers.

‘I don’t believe there are any artificial delays, particularly in the UK regulators are moving at warp speed in this sector. We have had lots of engagement and conversations with the FSA, which I think is testament to how governance is viewing this sector.’ Catherine Elton.

Regulatory bodies are there to protect the public, but the mission of organizations like CARMA, to transition to environmentally, economically, and socially sustainable food systems, is understood and shared by governments.

‘It is important to talk to regulators, as in any industry, regulation is often a two-way process between the industry and the regulator. We know more about our processes than anyone so we can open a dialog with them and help them understand the products and that’s the way to build regulatory acceptance and approval.’ Jon Dempsey.

‘We are subject matter experts here, so the more we can provide in terms of data and risk assessment to address common issues or concerns. Anything that can add more information to food safety and how the development of that product has come about, that is key to regulators and policy makers.’ Prithvi Kodialbail.

Do you think people might be more receptive initially towards a product or a cellular version which is not going into the food chain, for example, a silk alternative or leather alternative?

Public acceptance of novel alternative protein sources from cellular sources is important to the regulatory process and the ultimate commercial success of these products. The mission for a more sustainable food source and the future of food depends on its acceptance and economic viability. Other products which are not consumed, such as cell-based silk and leather alternatives may be easier for people to accept.

‘It’s an interesting point, but ultimately, I think that food is so emotive and personal, that nothing other than food will gain the acceptance of food products.’ Jon Dempsey.

‘There is something about having a cultivated alternative in your life and that does drive acceptance. But what we want is for people to have a choice, it’s about having a choice when you go to the supermarket and there’s a freezer with conventional meat and a freezer with alternative meat products, for those who want to try something different which address the economic problems. Our work is very important and relevant, if we’re going to shake up the industry and talk about it, let’s have this conversation in people’s homes, when they open the fridge and there’s cultured food.’ Prithvi Kodialbail.

Cultured meat and seafood products are being developed to address the unsustainable current world food situation and change the future for the better.

‘Cultured meat and seafood products are being developed as sustainable solutions to address the global food crisis and create a better future. As start-ups, we’re bringing forward revolutionary answers for a world that can no longer rely on current, unsustainable methods. While it’s essential to go slowly to shift public perception, the urgency for real solutions is now, food innovation is the path forward.’ Yennifer Cortes Araya.

Panelists

• Catherine Elton – CEO, Qkine
• Jon Dempsey – Roslin Technologies and independent consultant
• Prithvi Kodialbail – CTO, Extracellular
• Yennifer Cortes – Head of Cultivated R&D, Uncommon

The future of cellular agriculture looks bright, CARMA is bringing together industry leaders and academics in a transdisciplinary approach to deliver sustainable food manufacturing in the UK and beyond.

Qkine, which is partnered with CARMA is a specialist recombinant protein manufacturer has recently launched a range of exceptionally pure, agriculturally relevant species-matched food grade growth factors specifically for use in cellular agriculture. These have been developed with future regulatory novel food dossier preparation in mind under a HACCP food regime in an allergen-free process. Full documentation is available for these products including full raw materials traceability, protein allergen analysis, CoO, CoA, beta-lactam-free and animal origin-free certification.

View high quality food grade growth factors