Merck and Scaling Cultivated Meat: Cell Culture Media & Regulatory Support

This article was sponsored by Merck Life Sciences.

From Singapore to the United States and Israel, more cellular agriculture companies are working to bring their food products to market around the world. As more cultivated meat companies look to commercialize, there are still scaling challenges that companies in the field must address.

From scaling production to regulatory considerations, cultivated meat startups are exploring partnerships with a range of companies to develop their supply chains. For key supply chain inputs like the cell culture media and its components, for example, companies are looking to partner with companies with experience at the intersection of the life sciences and food industry.

According to Amanda Pavlicek, the commercial lead and biomonitoring specialist for cultivated meat in the Americas at the Life Sciences business of Merck (operating as MilliporeSigma in the US and Canada), companies like Merck are best positioned to support the field through scaling production and regulation to come to market.

Having worked with different cultivated meat and seafood producers, Pavlicek highlights how Merck and its various teams focusing on cultivated meat can help the industry achieve its goals of becoming part of a sustainable food system.

Merck: Applying Expertise in the Life Sciences to Cultivated Meat

Considering how the cellular agriculture field sits at the intersection of applying the latest in cutting-edge biotechnology innovation into the novel food sector, Pavlicek shared how Merck is uniquely positioned to support the growth of the cultivated meat industry.

“Merck is one of the leading global science and technology companies, and we're headquartered in Germany. Within the company, we have three business sectors: healthcare, life science, and electronics. I fall under the life science business of Merck KGaA Darmstadt Germany, which operates as MilliporeSigma in the US and Canada.

“The life science sector offers one of the broadest portfolios in the industry for scientists, and our presence extends well beyond the labs. We offer innovative products, services, and digital offerings to help create solutions for our customers.”

Cell-cultured salmon by Wildtype

According to Pavlicek, Merck has been exploring how to leverage its expertise best to enable the cultivated meat field. “Over the past few years, we have been thinking about how we can help the cultivated meat industry. How do we position ourselves to enable the industry?

“We started our research within our science and technology office, which is our innovation hub, where we started to develop a cell culture media for cultivated meat and seafood as well as the raw materials supply chain that is relevant for the industry to produce the basal cell media.”

After focusing on developing supply chain inputs for the field, Pavlicek shared that Merck transferred the project into a different business sector. “After building this cell culture media business, we moved it to our science and lab solutions, more specifically, the biomonitoring parts of our organization.

“This means we get to tap into our sourcing, procurement, and production and leverage all those excellent resources we offer within our life science organization. It's very exciting because we believe that'll help grow the cultured meat industry. And that’s where I come in.

“I am the commercial lead and the dedicated biomonitoring specialist for the cultivated meat industry in the Americas, so I cover North and South America. I also have a counterpart that supports Western Europe, EMEA, and APAC. We also have a team of experts within our R&D sector, regulatory, and other areas of our company to assist companies within this cultivated meat and seafood space.”

Basal Media Development: “The cell culture media accounts for about 30-50% of today’s operational and manufacturing costs.”

An essential way that Merck is working to support the field is through the development and scaling up of the basal cell culture media, a vital component that makes up most of the cell culture media formulation. According to Pavlicek, the basal media provides the nutrients the cells may need to replicate or differentiate into other cell types to become a cell-cultured meat product.

“When you’re growing cells, whether it is ex vivo or in vivo, there are fundamental inputs that are required. You need sugar, salts, amino acids, and several other components to support cell viability. This critical mixture is called the cell culture media. It's essentially liquid food for the cells to grow.”

Besides providing the nutrients cells need to grow, Pavlicek highlights how the cell culture media is a key scaling barrier for the field. “The cell culture media accounts for about 30 to 50 percent of today's operational and manufacturing costs. We're looking to leverage our company's expertise in cell culture media development manufacturing.

“We focus on this topic to provide cost-effective and scalable solutions that meet our partners' quality and performance needs and allow these customers to scale up their product and bring it to market.”

Optimizing Basal Media Formulations for Cultivated Meat Production

From formulation development to production scale-up, Pavlicek further breaks down how Merck works with cultivated meat companies across various stages to help them meet and optimize their basal media development needs.

“We've spent a lot of time talking with various stakeholders within academics, big food companies, startups, and regulatory authorities to ensure we're getting the basal media right. This way, we can support a lot of companies, no matter what stage they are at in the process.

“For example, say you have a [basal media] formulation. You're happy with that formulation and need X amount of media. We can produce that and send it to you as dry powder. But maybe you want to optimize your formulation, reduce costs, or streamline raw materials.

“You might also want to tweak or tune the concentration of raw materials to be more specific to your cell type and how you're culturing the cells, all while balancing the performance simultaneously.

“We can look at your formulation and say, this salt is more cost-effective than the one you're currently using in the formulation. Can we swap it out? We can check the performance and provide manufacturing recommendations, to help determine how we can optimize and figure out a formulation that works for your product.”

Considering the importance of producing and scaling the cell culture media formulation, Pavlicek shared that Merck is working with various companies at different stages of development. “[Based on the company’s needs], we’re [providing] it in small quantities and then on the orders of tons already.”

Scaling Cultivated Meat Production: The Importance of the Basal Media Supply Chain

Cultivated beef burger by Mosa Meat

As companies scale their production processes and supply chains to commercialize, Pavlicek shared she understands the challenges facing the field and the role that Merck aims to play in establishing the complete cell culture media supply.

“We know that two of the biggest challenges today are scaling and costs. Firstly, we’re specifically looking at the cultivated meat manufacturing process, like the basal media. As mentioned, the cell culture media currently accounts for around 30-50% of today’s operational and manufacturing costs.

“We want to build out the cultivated meat and seafood supply chain. This is relevant for the industry to produce any of these cell media for the different cell types out there.

“In order to do so, we're currently looking at the typical raw materials that go into the basal cell culture media, like the sugars, the salts, and the amino acids. We're working on sourcing these materials through our global supply chain network and bringing them into the lab, where we're testing across different cell types.

“We're generating data and demonstrating that these raw materials are compatible, maybe better performing, than some of the existing counterparts currently in some of these media solutions.”

In addition to evaluating components for the cell culture media, Pavlicek highlighted Merck’s work in testing the raw materials through its cell culture media facilities. “And then the other side [to scaling basal media production] is the qualification process of our facility. At a large scale, we have validated our manufacturing facility.

“We have a cell culture media production Facility of Excellence, allowing us to test and use the raw materials to produce [the cell culture media] at scale within our facility. That qualification process [for raw materials] is a result of our analytical testing. We do a validation of our suppliers and bring in suppliers into our supply chain network that would be relevant for the products and the industry.”

The Transition to Food-Grade Raw Materials for the Cell Culture Media

Considering how costly inputs for the basal media can be, Pavlicek acknowledged the importance of reducing the cost of the cell culture inputs to support its cultivated meat partners and, ultimately, developing food-grade inputs for the cell culture media.

“We understand that it will take time to look at these products and find cost-effective solutions. For example, say you have 50 to 60 raw materials [in the cell culture media formulation].

“We’re going to prioritize appropriately and try and balance the cost where possible, like which ingredients are huge cross drivers in the formulation, how many can be changed on a concentration basis within the basal formulation, and what part is driving the cost up.

“Over time, between building our supply chain of not just food grade raw materials but also exploring alternative pharma raw materials, we can look at optimizing and providing cost-effective options within these 50-60 raw materials for the cell culture media.

“Today, we have about ten raw materials qualified as food grade within our supply chain and can be used at scaled manufacturing. We will continue that process as we work further within our R&D team and with customers in this industry.”

Regulatory Support to Bring Cultivated Meat to Market

Beyond technical scaling challenges, regulatory approval is another critical aspect of bringing cultivated meat to market. As of the start of 2024, only three cultivated meat companies have received regulatory approval to launch their products.

Considering the costs of scaling up cultivated meat production, understanding the required regulatory processes will be critical for cost-effective and large-scale production.

Along with helping companies develop their cell culture media formulations, Pavlicek shared that Merck supports companies in their efforts and submissions for regulatory approval.

“A crucial part of cultivated meat and seafood product success will be the approval of those products as a food product. A successful cultivated meat industry will depend on working with partners who understand and deliver products that meet those regulatory needs.

“Whether it's assisting with your dossier, defining the quality of the regulatory parameters you want to be associated with your product, or maybe products for your HACCP plan, Merck or MilliporeSigma in the US & Canada have various teams full of experts that are willing to assist in meeting the needs of our customers.”

“We can assist [Cultivated Meat Companies] at any stage of the [regulatory] process.”

Pavlicek also stated that Merck’s regulatory support team can work with cultivated companies across different stages and aspects of the regulatory submission. “We’re not just looking at one part of the regulatory landscape. We have a regulatory support team and can assist customers at any stage of the process.

Cultivated meat sausages by Ivy Farm

“We’re committed to providing products that enable safe cultivated meat at scale. We're providing regulatory compliance and guidance where needed, and we also have our team of experts dedicated to safely accelerating our path to market.

“There are many different things that the regulatory agencies are looking at, and we’re here as a resource to help our customers at every step along that process. And if, for some reason, it's something we haven't experienced before, we will help you work through that process together.”

Case Studies: A Regulatory White Paper to Further Support Cultivated Meat Companies

To further support companies in their regulatory submissions, Pavlicek announced the release of a new white paper. “We recently published a white paper that will be a guide to regulations, HAACP, cell culture media, and quality control. In this white paper, we go over current regulatory landscapes as well as guideline principles for your HAACP plan, which customers will need in their dossiers to send to regulatory agencies.”

In addition, Pavlicek outlined how Merck has worked with several cultivated meat companies to support them, from basal media development to regulatory support.

“We are currently working with several cultivated meat startups at various stages within the process. Whether starting from the very beginning [where] we're working on optimizing and figuring out the [cell culture media] formulation or helping figure out those regulatory needs that you need with your scale-up media and products.

“We have had situations where we understand that customers need certain things to submit their product to the regulatory authorities. In those situations, we can figure out what testing documentation they may need to ensure their products get approved by those regulatory authorities.”

The latest white paper is available for download from the Merck website dedicated to cultured meat.

Conclusion: The Importance of Collaboration

From supporting startups by developing basal media formulations to regulatory dossiers, Pavlicek emphasizes the importance of partnerships and collaborating to create a broader ecosystem to make cultivated meat a viable part of our future food system.

“We really believe in strong collaborations and working together. [Building the cultivated meat industry] is not going to be a one-man job. We can’t do it alone, and we know that other people in the industry cannot do it alone.

“We believe that collaboration and working together will be important to figure out how we can provide cost-effective and scalable solutions to bring these products to market.

“Collaboration is going to be crucial within this industry. Every industry needs collaboration. We need to talk and share our learnings, and in doing so, I believe we could be successful in this industry.”

Moving forward, Pavlicek stated her team is looking forward to continuing its journey in supporting startups and companies in the cultivated meat field as one solution in a multi-solution approach that is needed for a sustainable food system.

“We’re very excited to be part of this industry to try and bring this to market. We’re looking forward to leveraging our internal teams, learning from what is happening in an industry, and working to grow them.”

This article was sponsored by Merck Life Sciences.