Tag Archives: cell cultured meat

Justin Dranschak

Cell Cultured Meat: Where Are We Now?

By Food Safety Tech Staff
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Justin Dranschak

In June, the USDA FSIS granted label approval and grant of inspection to two companies manufacturing cell-cultured meat: Upside Foods and Good Meat. This was the final step in the U.S. regulatory process, opening the door for commercialization. We spoke with Justin Dranschak, Director of BioPharma at Molecular Devices, about a potential timeline to sales, what this means for other manufacturers of lab-grown meat products and what impact these products may have on the U.S. and international food supply. A former employee with the Ohio Department of Agriculture and Siliker Labs, Dranschak has been working on cell line development for the past 10 years.

The FDA recently announced that it had no further questions about the safety of two cell-cultured meat products, which then went on to gain USDA grant of inspection and label approval. Can Upside Foods and Good Meat now sell their products commercially, and are these products ready for commercialization?

Dranschak: These approvals mean they can come to market, so the companies can now move forward with full-scale biofabrication. In terms of commercialization, there are still some challenges in terms of achieving price parity with meats now sold at the store level. The next step is optimizing production and scaling up the capacity of these systems. Everything up to now has been done on a small to medium scale, with a focus on thorough, rigorous testing. Scaling up from small to medium to large is a big challenge, and we’ve seen that in a lot of biological workflows as you’re dealing with different types of cells. They will need to optimize production and consistency of quality to ensure what they’re putting out in stores really matches what customers are looking for.

I recently saw a speaker who noted that the amount of meat or cells you need to create a final product is really not efficient or optimized? Has that been remedied or does that continue to be a challenge?

Dranschak: That is probably the No. 1 issue that is being looked at from a development perspective. But there are a lot of novel breakthroughs that are just on the periphery in terms of different styles of growth media that we can use, and different styles of vats and containers that we can use to ensure that the cells are getting correct feeding at the correct time and that you are then moving those onto the next step of the process at the right time. There are new technologies for monitoring and visualizing those cells. But those scaling efforts are the obstacle right now.

When developing lab grown meat, what is the manufacturing process?

Dranschak: The process starts with instrumentation called single cell printers. The company starts with a single cell taken from an animal, whichever animal they are using, and then they identify the cells of interest and put those in a machine that is then going to dispense a single cell into a 96-well plate. From there, they track that cell as it grows and multiplies. As you grow and multiply those cells, you also need to monitor them over time and prove that they did start from a single cell—that’s proof of monoclonality and that is what the FDA requires. The FDA wants to know where that cell came from and also the stability—ensuring that cell is not going to change or modify over time.

Once you’ve identified that you have these cells that match all the desired characteristics, that’s when you move into quality and production scale. At this point, you’re interested in things such as nutritional content and also biological content. Are the proteins in these cells the same as what we would see in regular chicken or fish? Are we seeing the same levels as we increase the number cells that we are producing in these vats? So, it comes down to a number of different groups working together in tandem to produce cell lines that are going to taste how consumer expect them to taste, and to ensure consistency over time.

If you start with a chicken, for example, and you extract some cells, do you then need to do that extraction for each future piece of chicken or can you build your own cell bank that becomes your product base?

Dranschak: You create a cell bank. These companies are developing thousands of cells and cell banks, and as they go through their processes they’re learning from each cell bank—identifying cells or methods that might over-produce or under-produce something. These cells are held for future learning so they can call on them at any time for development purposes or for future production runs.

What is the timeline in terms of producing a final product from a single cell?

Dranschak: It can take anywhere from 12 to 18 months up to 3 years. When looking at food versus a biological therapeutic, it’s a much more defined process, so I do see significant opportunities for shortening that cycle using automation—moving from more manual processes and synergizing those with robotics to move things in a higher capacity through the system. With advancements in AI and software, we’re also going to see a lot of process optimization in terms of the actual building design of these systems and incorporating the safety and sterilization processes that we have in pharmaceuticals and biotech back into the food industry for development.

Are there differences in terms of progress in the areas of development of cell-cultured poultry products vs. beef or seafood?

Dranschak: In terms of the path forward, this [FDA and USDA approvals] represents a major step because it provides a regulatory roadmap for the food industry and other industries using cell-cultured products. That being said, each process is different. Each cell line and each cell type has its own unique challenges in terms of how they grow, taste, function, etc. But the overall framework from a regulatory perspective has been set.

There is some wariness about cell-cultured meat, even within the food industry, are there unique safety concerns for lab grown meat?

Dranschak: They are largely the same. I previously worked in a food analytical lab doing microbiological testing with Siliker Laboratories. You’re going to be performing the exact same tests from the pathogen level as well as from a food characterization level. The main difference is the manufacturing process, and all of that has been extensively documented. It is extremely safe. Lab-grown meat does come with challenges from a public health perspective because it is something new. Overcoming that challenge requires education.

To me, this is an amazing and positive step forward. It offers us an opportunity to meet food challenges in parts of the world where, for example, they are unable to have access to meat on a regular basis. Lab grown meat allows us to address global food crises and support global health through science and the development of new products.

 

 

U.S. House of Reps seal

House Appropriations Bill Highlights Support for Restructuring of FDA

By Food Safety Tech Staff
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U.S. House of Reps seal

The U.S. House of Representatives’ Committee on Appropriations has directed the FDA to unify its food program under a Deputy Commissioner for Foods and highlighted additional priorities for the agency related to cell-cultured meat products, allergen labeling and quantitative pathogen testing.

In its recent bill appropriating funds for the USDA, FDA and related agencies for fiscal year 2024, the committee laid out its priorities for these agencies, including:

Human Foods Program Restructuring. The Committee directed FDA to unify the foods program under an expert, empowered Deputy Commissioner for Foods with full line authority over CFSAN, the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all food-related components of the Office of Regulatory Affairs, including inspection and compliance, food-related laboratories, import oversight, State partnerships, training, and information technology.

Allergen Labeling. The Committee stated that it is concerned about the increase in the diagnosis of food allergies to new and emerging food allergens not currently required to be labeled. The Committee urged the Center for Food Safety and Applied Nutrition (CFSAN) to identify potential future food allergens that would require labeling on food packaging and to implement the required process toward labeling on packaged foods.

Cell Cultured Meat Labeling. In light of the FDA’s first pre-market consultation for a human food made from cultured animal cells, the Committee stated that it is interested in the internal FDA protocols related to pre-market consultations for cell-cultured protein products, specifically whether or not there are special or unique considerations made for these products in pre-market consultation processes. The Committee requested a report outlining the pre-market consultation process for cell-cultured protein products, noting any special accommodations made to comply with the Formal Agreement between the FDA and the USDA and any agency plans to coordinate with its counterparts at USDA on further action regarding the same products.

FASTER Act. The Committee shared its concerns of reports that companies are circumventing the intent of the FASTER Act by intentionally adding sesame to food products to avoid the cost of preventing cross-contamination. FDA is directed to report on implementation of the FASTER Act, including plans to address this issue and an analysis of whether actions by companies in response to the Act’s passage violated federal food safety rules.

Listeria. The Committee directed FDA to apply a risk-based approach and direct its regulatory efforts toward high risk ready-to eat foods that support the growth of Listeria monocytogenes (Lm). Additionally, the Committee encouraged a regulatory approach that encourages industry to adopt quantitative Lm testing schemes and facilitate robust environmental monitoring programs. The Committee directed FDA to work with industry stakeholders to gather supporting information and data to assist with implementation of this Lm approach to align with other international regulatory standards and restore a level playing field for U.S. food processors in the global marketplace.

Tami Dumond
Women in Food Safety

I Enjoy Being Afraid

By Food Safety Tech Staff
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Tami Dumond

Those who work in the food safety and quality industry may know Tami Dumond, microbiologist and Director of Quality Assurance at Omeat, by her oft-changing vibrant hair color. Her career has been equally varied. Dumond has worked as a scrub nurse, QA lab manager and owner, motorcycling instructor and food quality manager and director.

Tami spoke at a recent meeting of the Women in Food Safety about the path that brought her to her current leadership position at Omeat, a tissue engineering company scaling cellular ground beef, and the value of varied work experiences.

I Like To Party

After graduating high school, Dumond entered a one-year hands-on certification program to become a scrub nurse. “It taught me a lot about showing up and the importance of processes and protocols,” she said. “Almost everything I do in food safety and quality brings me back to things I learned in surgery.”

She chose the program because it allowed her to pursue her interest in science without going to college. “I am dyslexic and I didn’t want to go to school anymore,” said Dumond. “I liked school, but it was very hard for me.”

When she became a single mom, she decided to go back to school to earn a Bachelor’s degree, and got a part-time a job at an external quality control laboratory that worked with several food companies, eventually becoming co-owner of the lab. “I learned I was good at managing things,” said Dumond. “I’m a partier and I want to invite everyone to the party. I solidify my teams by including everyone and making sure they always have fun during training.”

Different People Learn in Different Ways

When the economic recession of 2008-2010 hit, rather than cut staff or pay at her lab, she chose to take on the second job as a motorcycling instructor to help make ends meet. “The students would read what they’re supposed to do, hear what they’re supposed to do, watch the instructor and then we watch them,” said Dumond. “That repetition and format of learning—if you didn’t get it verbally, you got it visually—reminded me that different people learn in different ways, so you need to offer information in multiple formats.”

During this time she also joined a local Roller Derby team, “The Soy City Rollers,” as MRSA Nary (mercenary), an experience that brought into focus the joy of being part of a team and, again, the importance of having plans and protocols. “Teams that play well have a playbook,” she said. “If you don’t have a process in place, pull out a whiteboard and write one right away, and do it with your team.”

Time for a Change

After 20 years at the lab and 11 years teaching motorcycling, Dumond—now a microbiologist—decided it was time for a change. She moved to Austin, Texas, with an eye on entering the field of food safety. “I wanted to be more involved in the food industry, because that is where a lot of innovation was taking place,” she said.

She got a job as food quality manager at ATX Specialty Foods, before moving to Omeat. Her goal as Director of Quality Assurance is to empower her team and bring a culture of food safety to the entire organization by making it as easy as possible for people to do the right thing. “I try to empower my teammates and create trust so they know they can come up and talk to me anytime,” she said. “I involve the entire team in training and when anything new is happening. I have made everyone aware of the importance of everything that goes on in the lab. Maintenance team members come to our PCR training so they can better understand the equipment.”

She values the relationships she has built with her teammates throughout her career and stays in contact with many past colleagues and employees. “Even if you leave a company, you don’t leave the people you worked with,” she said. “You never want to burn bridges.”

Sharing Knowledge

Today, Dumond describes herself as a quality scientist who specializes in biological business modeling. In addition to her role at Omeat, she is the founder of Qronika Consulting, which focuses on food safety training and industrial biome investigations. The company is named after a video game character. “Qronika is a titaness of good and evil, who knows you must balance good and bad to move through life,” said Dumond.

In her free time, she volunteers with Texas Food Bank and Food Rescue, as it provides the opportunity to support her community and experience different approaches to how people work with food.

Looking back on her career, she credits her success to always meeting challenges with action. “You have to show up and make the best of the situation,” she said. “And we, as a food industry, need to start paying attention to cellular Ag, and being more high-level in the biological sciences of food safety and quality.”

During the meeting, Tami shared her “Words to Live By”:

I Like to Break Things. If you break things, they can be fixed. If something is wrong, then we’ve got to dismantle it and rework it.

I am Petty. Every quality professional is petty. We worry about the small things.

I Take Things Personally. My life and my career is personal to me

I Party a Lot. I am an entertainer. I am an artist. I try my best to make everyone comfortable in a conversation. With me, you’re going to have a good time and I’m going to figure how to get what I need to get from you in order to make your job better.

I’m a Time Traveler. Everything I’ve done since that first job as a scrub nurse at 18 has brought me back to what I learned when I was 18.

I Steal Things. If a teammate has a good idea, it’s going upfront and I want it. We’re always downloading stuff, incorporating it and making it our own. Don’t waste opportunities or other people’s knowledge.

I Enjoy Being Afraid. Fear means there is an unknown. When we’re afraid, if we can understand that it’s a fear of the unknown then we can learn and become less fearful.

 

 

 

FDA

FDA Asks for Comments and Evidence to Aid in Labeling of Cultured Seafood Cells

By Food Safety Tech Staff
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FDA

FDA has issued a Request for Information in an effort to gain information and data about how to properly label foods made with cultured seafood cells. The goal is to help FDA determine next steps in ensuring that products derived from cultured seafood cells are labeled consistently and transparently. The “Request for Information: Labeling of Foods Comprised of or Containing Cultured Seafood Cells” will be published on the Federal Register on October 7, and there is a 150-day comment period.

“The FDA invites comment, particularly data and other evidence, about names or statements of identity for foods made with cultured seafood cells. The agency is also interested in information on consumer understanding of those terms and how to determine material differences between cell cultured and conventionally produced seafood,” FDA stated in an email constituent update.

The labeling of foods derived from cultured seafood cells falls under FDA jurisdiction. In March the USDA and FDA entered into a formal agreement regarding the oversight of human food made from cells of livestock and poultry.

Lab grown meat

“Real” Beef: It May Not Be What’s For Dinner Anymore

By Maria Fontanazza
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Lab grown meat

As the consumer craze over plant-based meat continues, cell-cultured meat is next on the list of alternatives to “real meat”. There are several factors driving this market, including increased demand for meat as the world’s population grows and becomes more affluent, and the concern that if more sustainable solutions are not implemented, there won’t be enough protein to feed the world’s population by 2050, according to Paul Mozdziak, professor at NC State University. Mozdziak, who presented his perspective on cell-cultured meat during the IAFP Annual Meeting last month, has been working in the cell-cultured meat space for 25 years. It’s not a new concept, he pointed out, but sustainability issues, concerns over the efficiency of the animal industry (i.e., the biological limits of animals), along with a waning enthusiasm in eating animals have sparked even more interest in animal technologies during the past few years.

Animal cell culture technology involves a controlled growth of animal cells from livestock, poultry, fish or other animals, their subsequent differentiation into various cells types, and their collection and processing into food, according to Roberta Wagner, assistant administrator, Office of Policy and Program Development at FSIS, USDA. Wagner shared the regulatory perspective on this emerging segment at IAFP. And although the session in which Wagner and Mozdziak spoke was titled, “Is Cell-cultured Meat Really Meat?”, neither of them answered this question. Rather, they discussed the status of the sector and the challenges ahead.

Scale Up

“The technology has been around,” said Mozdziak. “The issue is getting it to scale and myogenic to actually produce product.” Muscle cells want to attach to something. The process of making cultured meat involves isolating cells, getting them to grow in suspension and transferring them to a bioreactor to grow. In order to create a fully formed muscle, the cells needs to attach to a scaffold and differentiate, he explained. The bioreactor facilitates a sterile environment, but when scaling up, the challenge is the unknowns (which could introduce food safety issues) during downstream processing. “Once it’s out of the bioreactor and in a non-sterile environment, there are a variety of ways it can be contaminated,” said Mozdziak.

The production process could be cost prohibitive as well. “Currently, serum-based media cost $25 a liter; serum-free is $104 a liter. How much lower can we go from that?” said Mozdziak. “A kilo of turkey at ALDI is $6… therefore the media costs would have to be below $12 a liter for this to ever be profitable.”

How Will It Be Regulated?

In October 2018, FSIS and FDA held a joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The agencies also started talking about what regulatory oversight might look like. In March of this year the USDA and FDA reached a formal agreement on joint framework for regulating cell-cultured meat and poultry products. FDA will regulate the extraction of cells from live animals and jurisdiction will be transferred to FSIS during the cell harvest stage, and FSIS will oversee production and labeling. “The agreement roughly mirrors our jurisdiction of both agencies for traditionally produced livestock,” said Wagner. She added that regarding FSIS authority over cell-cultured products, the agency does not expect there will be a need for additional legislation nor will there be new regulation to inspect the products (Establishments that harvest cells or process the cells must comply with sanitation, HACCP and any other applicable FSIS regulations). Labeling for cell-cultured meat and poultry products must be approved.

Wagner noted two major challenges ahead in the federal regulation of cell-cultured meat. “We’ve received very little information about the process and technology being developed or used by cell-cultured meat and poultry manufacturers,” she said. “If industry doesn’t share such information, there could be a delay in review of products.” She added that the agency is encouraging industry to come forward sooner than later with this information. The second big challenge involves research and science gaps—more is needed to understand the risks.

So, is cell-cultured meat really meat? “Before we can answer that, someone needs to actually have a product,” said Mozdziak. He believes industry will get there in creating marketable cell-cultured meat, but there is no telling how long it will take.

magnifying glass

FDA, USDA Formally Agree to Regulate Human Food Made from Cells of Livestock and Poultry

By Food Safety Tech Staff
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magnifying glass

Today FSIS and FDA announced a formal agreement regarding the regulatory oversight of human food products derived from the cell lines of livestock and poultry. The agencies will jointly oversee regulation of these cell-cultured products to ensure both safe production as well as accurate labeling.

The agreement involves a joint regulatory framework in which the FDA will manage cell collection, cell banks, and cell growth and differentiation. During the cell harvest stage, FDA will transition oversight to FSIS and from there, FSIS will oversee production and labeling of the human food products that are derived from the cells of livestock and poultry.

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in a USDA press release.