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Published in September 2020

Regulatory Framework for Cultured Food Products in Canada – White Paper

Cellular agriculture (also known as “cell ag”) is the field pertaining to the science and manufacturing of agricultural products from cells, rather than from entire animals or plants. It uses living cells grown in culture to create products that mimic traditional agricultural products, such as meat, dairy or leather. It combines multiple fields such as biotechnology, genetics, tissue engineering, bioengineering, medicine and food science. Due to its novelty, the regulatory pathway that will allow these products to be commercialized in Canada needs to be paved. Therefore, based on a preliminary meeting with government officers, a white paper was written at Cellular Agriculture Canada by Netta Fulga and Yadira Tejeda Saldana. The paper intends to outline the initial steps to achieve regulatory approval of cell cultured food products and serve as a guide for cell ag companies that will be required to undertake the approval process.

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Cellular Agriculture – A Retrospective Look 20 Months Later

Farm animals

I recently read a very interesting article in which Davide Banis asks Paul Shapiro to make predictions about what will happen to Clean Meat in 2019 (  The article is generally encouraging, and it shows how much this emerging industry has advanced in the few years since it started. However, not surprisingly, Mr. Shapiro does not predict that the major challenges that cell agriculture has to overcome, such as scale-up/cost and structure would be solved in 2019.

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This article got me to re-evaluate my own posts written in early 2017 (  In those posts, I tried to address some of the challenges that cellular agriculture will encounter and how, in my view, they could be overcome.

It was very pleasing to see how much our industry has grown in the last two years. Back then, I could only find less than a handful of companies developing clean meat. Today, there are several tens of companies spread over several countries with the US, Israel and the Netherlands being the main locations. Diversification of the products is even more encouraging. Beef, pork, poultry, seafood, and even fois gras are all targets for future products.

Two years ago, the decrease in price from hundreds of thousands to only thousands of dollars was considered meaningful. Today, we could hear from several clean meat developers that the cost is in the range of tens to hundreds of dollars per pound  ( For example, Aleph Farms’ small slices of steak cost around $50 a piece. Although the cost is still prohibitive for commercialization, this shows the major progress made in this field in such a short period. It seems to me that scale-up processes are not yet sufficiently refined to mass produce clean meat, and we are still not yet at the stage that cellular agriculture products can easily be commercialised. However, we are much closer to this goal than we were before and certainly are on the right track. Furthermore, even if it will still take time (according to Aleph Farms, 2 years) until we eat the first clean meat steak, “interim products” such as minced beef, sausage or surimi, may be commercially available (even if on a limited basis) in 2019.

Following several public consultations that took place in the last months, a few weeks ago, the FDA and USDA announced that they have established a regulatory pathway for clean meat ( They will jointly regulate these products based on their specific expertise. Companies like Memphis Meats and others should be commended for engaging early in a dialogue with the US regulators. The resulting policies, even if not yet tested in the real world, are clearer for developers of cell agriculture products to assess and comply with. Thus, companies can streamline their processes and focus on the major product parameters early in their product development stages.

The US regulators have taken a leadership role in clean meat regulations. Unfortunately, other regulatory authorities have not followed in their footsteps and the requirements for such products in other countries remain to be determined.

Last week, Aleph Farms released a video of its first lab-grown steak. The news produced lots of excitement not only in our small industry, but also in the general public. Major media networks like the Wall Street Journal and Business Insider gave the news great attention, propelling it into their top pages. WSJ even released a clip on how it was cooked by a chef and then eaten by Jason Bellini, their Senior Business Correspondent ( As per Didier Toubia, Aleph Farms’ CEO, the taste and flavour are 60-70% of what the company expects them to be. However, the texture is already there and the improvements required will probably come soon.

Interestingly enough, a few days ago, I spoke with a vegan friend who said that he would be very happy to pay and eat Aleph Farms’ steak as it is now. Obviously, he may be craving some meat after not touching it for a very long time. The general public though, will probably still prefer to wait until the taste and the texture are closer to 100%.

Texture and taste are very complex features that depend on a variety of factors. The ability to incorporate cells from several lineages (muscle, fat, connective tissue and blood vessels) enables the achievement of such complex features. Aleph Farms’ technology seems to be quite sophisticated and is supported by patents licensed from the Technion – Israel Institute of Technology. It is a reputable institution employing scientists who have worked in the regenerative medicine field for decades. It is not clear what type of cells they start with, but it seems that they both expand the cells as well as differentiate them into various tissues. Facts that give them a significant advantage in attaining their goal.

I was intrigued by Just’s announcement a few days ago that they will develop a product made of Wagyu beef. To me, taste is a major challenge of cultured meat and trying to mimic such a high-end meat product may be too difficult at this early stage of the industry. Time will tell if this was a good decision. I still think that we should first focus on developing more moderate-tasting meat.

I must admit that it was quite exciting to review what I wrote almost two years ago in light of the accomplishments that cellular agriculture has achieved up until now. The progress made and the increasing number of players in the sector, many of them supported by sound science are encouraging. I am looking forward to the first products available on the market. I plan on being one of the first people standing in line to try them…


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Cellular Agriculture – the potential and the challenges. Part VI– Taste and textureTaste and texture - Ferrero Rocher

In my previous posts, I tried to tackle pricing and scale-up ( ) and regulations (, two important challenges that cellular agriculture companies will have to address early and proactively. Ultimately, cellular agriculture is all about food and the products need to be tasty for the people to buy them.

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Obviously, the vegetarian and vegan population will adopt such products earlier since they compete in a relatively limited (although increasingly diversifying) market. However, if this new industry wants to become mainstream, it should provide products that can compete with the “real thing”. Not all the people are the same and each of us prefers certain tastes and textures.

One of the initial difficulties with the first stem cell burger was that it was too chewy. We all know that a good steak needs marbling (the fine veins of fat that melt during grilling and make the steak tender). Same thing with the burger; it needs some fat. Dr. Post’s burger was made entirely of muscle cells, which gave it a reasonable good flavour (at least according to the individuals who tasted it), but it was difficult to chew. Furthermore, to overcome the difficulties related to meat texture and tenderness the developers may require the use of appropriate scaffolds and differentiate the stem cells into several types of cells.

Significant thought and effort will be required to achieve a combination of taste and texture that will be palatable to most of the population. To overcome this challenge, companies should seek scientific advice from professionals working in the food industry. In addition to food scientists, advice from individuals with cooking expertise such as chefs could be invaluable not only practically during the product development process, but also as an early engagement in business development activities.

It seems to me that a more difficult challenge than the texture will be the taste. It is quite established that the flavour of the meat of animals raised freely and fed natural food tastes much better than farmed animals. Furthermore, meat of certain species of animals tastes better than others. Even though the main competition of the cellular agriculture products will be with meat and other products derived from animals raised in precarious conditions in large farms, the taste of cell agriculture meat must be sufficiently appealing to the general palate. Even though the target comparison would be the “low hanging fruit”, a significant decision would be the species from which the stem cells are collected. The decision should also take into account parameters such as actual taste of the meat derived from the living animal, its availability in nature and the ability of cells to sustain growth (and retain their taste) in culture. Prioritization of the products in the pipeline would be very important and it seems to me that at least initially, the cellular agriculture products should compete with moderately-tasting products and not the high end ones. In other words, let’s try and make a decent Angus beef steak before we make a Wagyu one… and even though blue fin tuna is tasty and expensive, tilapia has an important place in the fish consumer market and its flavor would be easier to replicate.

Cellular agriculture is a disruptive industry that can change the way that food is produced today. It has great business potential in addition to the crucial positive impact that it could have on the environment, increased sources of food and decrease animal suffering. As this novel industry emerges, it is very important to recognize the challenges that it will encounter, try to anticipate them and find ways to overcome them preemptively. Such activities will enable the industry to thrive and become successful reducing the risk of failure which could hurt its efficient and rapid evolution. 


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Cellular Agriculture – the potential and the challenges. Part III – Regulatory requirements

Regulatory folders

In my previous post (see below) ( I started outlining the challenges that cellular agriculture as a new industry spearheaded primarily by young entrepreneurs has to overcome in order to become a viable and successful field.

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In this post, I will concentrate on another major issue which needs to be addressed pro-actively – the regulatory framework of novel food products. We expect regulatory requirements for cellular agricultural products to be higher than for naturally-occurring food products. No one knows yet how these products will be regulated since there is no comparable product on the market yet. One could argue that the approach will be similar to genetically-modified products. However, the actual raw material (cells) of these products could be naturally-occurring with relatively low risk to the consumer.

Since the use of antibiotics would miss at least some of the advantages of cultured meat (as opposed to most of the meat products sold today that derive from animals given antibiotics continuously), major efforts will be made to keep the cell culture and its outcome sterile, or at least sufficiently clean to avoid contamination that could be damaging to consumers. Even if the raw material does not contain bacteria, the risk of contamination with adventitious agents would be a major concern. Closed systems of manufacturing will be required to maintain the cell culture sterile and assessment of contamination would most probably be a major request of the regulators. Would other criteria (viability, purity, identity, etc.) used for cell therapies be transferred to cell-based food products? Too early to tell, but addressing these issues in advance would be very useful to both the regulators and the developers.

It is difficult for early stage companies and young entrepreneurs who are overwhelmed by the day-to-day demands of managing their teams and trying to develop novel products to address regulatory concerns. Especially since regulatory guidelines have not even been delineated. However, trying to develop manufacturing and testing procedures and validating them, and compiling them in written SOPs (standard operating procedures) could be of great help down the road. More importantly, engaging in a dialogue with regulatory bodies at an early stage and discussing the matter, exchanging opinions and explaining the processes and the goals would facilitate the development process down the road and make it more efficient. Confusion about regulatory requirements may lead to crucial delays in product development at later stages when changes and adjustments are more difficult to make and significant funds have already been invested in processes and systems that could become obsolete. Engaging early in discussions with regulatory bodies could overcome such difficulties and enable a more rapid and cheaper product development pathway with more lucrative outcomes at commercialization.

In my next post, I will address a matter that at first sight seems to be less scientific, the taste and the texture of cell-based food products. Significant thought needs to be invested in developing tasty products and scientific methods need to be employed to solve some of the issues that have already been observed in these early stages. In my view, taste and texture could be the crucial points that will make or break cellular agriculture products.  


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Cellular Agriculture – the potential and the challenges Part II – Some of the Challenges


Some of you may have read the first part of my post about cellular agriculture (see below). It focused on the potential of this novel industry ( This part outlines some of the challenges that this new industry may encounter.

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As in any new field, challenges and difficulties occur everywhere and it is not the scope of this post to cover them all. A pro-active approach will help the entrepreneurs reach their goal more efficiently.

In my opinion, there are three main challenges to be overcome in order for cellular agricultural products to become part of our daily diet.

1.      Price and scale-up

2.      Definition and compliance with regulatory standards

3.      Taste and texture

For a long time, biotechnology was used in agriculture and despite the concerns that certain lay individuals have about genetically-modified plants (and lately animals), the outcome of using biotechnology in agriculture is remarkable. It is the time to utilize the most ground-breaking scientific discoveries not only to find cures for devastating diseases, but also to increase our sources of food in a sustainable and eco-friendly way. Cellular agriculture could be the next big thing in science and technology. However, in order to make it a success, we need to do our homework in advance and try to pre-empt the challenges that will emerge as we move forward.

There will be early adopters of cell-based food products and others who will not be willing to touch them. Most of the population will be in-between and it is a matter of time until these products will find their way to the local supermarkets. They will compete with the animal-derived products and gradually conquer a fair share of the market. It is clear though that the biggest challenge before this happens would be the price and in order to become affordable these products will need to be mass produced.

Scale-up is a difficult endeavor. In biotechnology it is even more difficult. Mass production of cells is one of the most challenging goals. Regenerative medicine, a branch of biotechnology that develops cell and gene-based products, needs to address this challenge urgently in order for its therapeutic products to fulfill their promise. Paying hundreds of thousands of dollars for a therapy, even if ground-breaking, is prohibitive and the problem has been recognized by several organizations, including large companies like GE Healthcare. The need to automate, standardize and streamline cell manufacturing and to reduce the cost of goods became lately one of the most sought after goals. Implementing these goals improves process control, reduces errors and increases consistency across multiple sites. More robust manufacturing procedures will counteract one of the main drawbacks of working with living cells – variability, which is an integral part of cells’ nature. Extensive work to develop automatic systems to produce cells is ongoing and results are expected in the next few years.

Since scalability begins with automation regardless of the sector, it is actually good news for cellular agriculture. As food products are expected to take a few years until they are developed, we could hope that scale-up processes and systems for regenerative medicine will be available by then. Today’s scientific methods need to be adjusted from human cell research to animals in order to develop agricultural cell-based products, scale-up methodologies too will need to be adjusted to fit the needs of mass consumption.

Cell manufacturing is expensive. However, our knowledge derives from what we learned from cell therapies. Not only do these products require large and very expensive clinical trials to assess safety and efficacy that take many years, but since the risk is high, the standards of manufacturing are also very high. Tedious and detailed quality control methods are required in order to assess purity, identity, viability, potency and biological activity. Cell therapy processes need validation and are strictly controlled by standard operating procedures. Cellular agriculture products will probably require less stringent manufacturing and control procedures. Thus the cost would be mainly dependent on the ability to mass produce efficiently.

It is still early to predict how the manufacturing process will develop and if indeed the cost of cellular agricultural food will become affordable. I believe it will. Addressing scalability and cost of goods early in the development process would be very helpful in attaining this goal.

Part III will tackle the regulatory approach 


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Cellular Agriculture – the potential and the challenges – Part I

Steak in a Petri dish

… Global population in 2016 according to the UN – 7.4 billion people … to reach 9.5 billion in 2050 (World Economic Forum)…

… Livestock is the world’s largest user of land resources – almost 80% of the total agricultural land (World Livestock 2013 the UN Food and Agriculture Organization)…

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…The livestock sector is responsible for 18% of greenhouse gas emissions, which is a higher percentage than total transport emissions (Livestock’s long shadow – UN Food and Agriculture Organisation, 2006) …

…around 80% of the antibiotics sold in the U.S. are used in farm animals, not in human beings, and 90% of that amount is dispensed through feed or water which could lead to the rise in antibiotic-resistant bacteria (US FDA)…

Even if we know that animal agriculture negatively impacts the environment and that growing animals for food is not the most efficient use of our resources, we need sometime to actually read the facts in order to understand its global multi-faceted effects. Not to mention the animal suffering that comes as a result of this. There are various ways to try and minimize the problem. Certain individuals become vegetarians, others reduce their meat intake, the price of meat increases, animal farming becomes more efficient… But how can we really address the issue effectively and sustainably?

For most of us, biotechnology means primarily the ability to develop and manufacture new and (hopefully) effective drugs. Even though similar methodologies are used to develop other products, we still regard biotechnology as the industry that brings us therapeutics.

The scientific discoveries of the last few decades have led to impressive progress in many fields of biotechnology. Novel discoveries, such as DNA sequencing, stem cells and the ability to manipulate them, and recently the CRISPR/Cas9 system for gene editing, could change medical therapeutics as we know it and lead to drugs that can indeed cure diseases hitherto considered incurable.

It is obvious that these disruptive technologies can and should successfully be utilized in other fields for the benefit of humanity. One of these emerging sectors with the potential of revolutionizing the food industry is cellular agriculture. It is a branch of science that fuses biochemistry, cell biology and farming. Using breakthrough technologies, existing agricultural products such as milk, eggs, and meat could be manufactured in a laboratory without the need to farm animals.

These innovations stem from a growing need to find a sustainable solution for the challenges facing the agricultural sector and humanity as a whole, such as urbanization, increasing CO2 and methane emissions, growing water consumption, and a booming global population growth. Furthermore, two additional trends are driving the progress of cellular agriculture; increasing awareness and concern for animal well-being and a growing health-consciousness of the population. Thus, as the number of vegetarians and vegans increases, the demand for non-animal derived products grows, with cellular agriculture products being the perfect solution. 

The opportunity has been recognized by the private sector and young entrepreneurs. Small start-up companies working to develop milk without cows, eggs without chickens and meat without slaughtered animals are emerging. Early successes in the field have already been seen, with the first burger made of cow stem cells in the laboratory of Dr. Mark Post in Maastricht, the Netherlands, being vastly advertised in 2013. The development cost was over $300,000 and was funded by Sergey Brin of Google. At that time, the idea was considered esoteric not only because of the tremendous cost, but also because it was questionable whether people would be even willing to consume lab-grown meat. Since then, at least two companies were established with the goal to develop stem cell-based meat. They were able to refine the technologies and the cost of manufacturing went down to a couple of thousand dollars, a significant improvement, but still an impossible price to pay for such a product. In parallel, early study shows that over half of the population is willing not just to try, but to actively eat cultured meat at a cost cheaper than conventional meat products. That is even before considering the benefits to the society and the reduction in animal suffering.

The science of harnessing the power of stem cells to produce meat in the lab is quite established. It obviously needs adjustments in order to become commercially useable and we are still 5-10 years away from the time that we’ll be able to consume meat produced in a bioreactor. However, in addition to the obvious benefits to humanity, the lesser risk of contamination and the healthier diet, the business potential is tremendous. It could be soon thereafter that we will be able to create raw food products according to our own taste, shape, color and size, control the amount of fat, or even consume meat of endangered or extinct species without worrying of any negative impacts… and let’s not forget our aspirations of visiting and inhabiting other planets…


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Canada – a port of entry to North America for Israeli Life Science Companies

Cardiologists at work

The Canadian life sciences industry is an important contributor to Canada’s economy, with a strong emphasis on innovation and aiming at improving healthcare delivery and patient care in Canada and abroad.

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According to a recent (March 2016) KPMG study (, Canada is the most cost-competitive country among the G7 group in many aspects. Canadian life sciences capabilities encompass world-class basic research and clinical practice combined with excellent product development and manufacturing expertise. Canada’s health research institutions and research networks partner with the industry in knowledge translation into commercial products. In parallel, Canadian contract service providers offer industry support for research and development, clinical trials and manufacturing. Furthermore, with the Canadian Dollar significantly cheaper than its US counterpart, and the big tax incentives for any research and development performed in Canada (including clinical trials), the costs of performing such activities in Canada are also substantially cheaper than elsewhere. All these excellent capabilities are supported by a flexible and timely regulatory framework that understands the need for innovation while implementing the highest standards of ethical and regulatory principles.

The Israeli life sciences industry is globally recognized as fast growing and successful and it plays an important role in the global healthcare market. It combines innovation and excellence in academic research with strong entrepreneurial culture, backed by government support and increased availability of funding. All these factors lead it to continually demonstrating encouraging parameters of maturity soon to be translated into commercial success.

The strong economic relations between Canada and Israel have led to numerous successful collaborative projects. Only a few months ago, Ontario’s Premier, Hon. Kathleen Wynne headed a mission to Israel that included over one hundred delegates representing life sciences institutions. According to the Ontario Government, forty-four agreements valued at over $180 million were signed during the visit, strengthening even further the excellent bonds that exist between the two countries.

Israel is a small country and companies need to move beyond its borders in order to enter the large markets and become commercially successful. Thus, similarly to Canadian companies, many Israeli life sciences companies envision the US as their primary expansion goal. By collaborating with Canadian life science companies, Israeli companies can benefit from these high-quality cost-effective capabilities and target Canada as their port of entry into North America and eventually the US.

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