This is an interview with Uri Lee, CEO of Xcell Therapeutics. Xcell is an international leader in serum-free, chemically defined media. In this interview, we discuss the mission and purpose of Xcell Therapeutics, its product development pipeline, its rapid growth, and the company’s future goals. Enjoy.
Cade Hildreth: When and why was Xcell Therapeutics formed?
Uri Lee: Xcell was founded in September 2015 with a vision to establish leadership in the advanced therapeutics industry. Our company’s mission is to contribute to the future of humankind through advancement of science and technology with CAMPs (Customized and Applicated Medium Platform), our backbone technology. Through CAMPs, we have developed CellCor™ CD MSC, the world’s first chemically defined cell culture media for MSCs manufactured under GMP, which commercially launched in year 2021.
Cade Hildreth: Where is Xcell headquartered and what markets do you serve now?
Uri Lee: Our HQ and R&D labs are located in Seoul, South Korea, and our manufacturing facility is located in Yongin, South Korea. We currently have 16 international distributors, and are particularly active in Europe and the US. We anticipate to be able to offer our localized products and services globally in the coming years.
In Europe, we started an active marketing late last year with our distributor PeloBiotech. They have been actively working with us, participating in conferences and undertaking aggressive marketing of our CellCor products. They will be co-attending the ISEV 2022 Annual Meeting (International Society of Extracellular Vesicles) this May in France, co-sponsoring the event, where we will be presenting a poster.
This past February, we officially launched marketing in the U.S. through our distribution partner Gemini Bioproducts LLC. We will be hosting a booth and giving a poster presentation at the ISCT 2022 Annual Meeting (International Society of Cell and Gene Therapy) also May of this year in San Francisco, where we have already seen substanial interest in our products.
We also have signed distribution and marketing agreements in other geographic regions, such as Canada with AFS Bio, Brazil with Interfarma, and Lithuania with LT Biotech (Elbis). We are actively seeking distributors within China, ASEAN, MENA, Oceania (especially Australia), and the Nordic regions in Europe.
Cade Hildreth: What is the difference between serum containing media, serum-free media, and chemically defined media?
Uri Lee: Traditional serum containing media is FBS (fetal bovine serum) containing media. FBS is an extract from calf blood, which is animal-derived. The causes considerable contamination, supply, and ethical issues to be associated with its use.
This has led to the development of serum-free (SF) and xeno-free (XF) media alternatives. Most of these products still contain animal-derived or human-derived components—such as bPE (bovine pituitary extract), hSA (human serum albumin), and hPL (human platelet lysate) that replace the use of FBS. These products are more defined per se than a serum based media, but still have contamination, supply, and traceablility issues. This was evidenced well with the supply shortage of hPL derived products during the Covid pandemic.
The ideal media should be chemically defined, in which all components are known and defined. This allows them to be risk mitigated for contamination, supply, and traceability issues. It also enables research to be highly reproducible, with a reduction in lot variation. Our CellCor™ CD MSC has been developed to address these issues, in addition to being easy-to-use since it eliminates the need for coating and supplements.
Cade Hildreth: Why did you choose to focus Xcell Therapeutics around GMP-grade chemically defined MSC media and what are the advantages of Xcell’s media over other alternatives?
Uri Lee: The regenerative medicine and cell therapy space as an industry is still in its early stages, although it is rapidly developing. For cell culture media developers, this development has brought the demand for more innovation and quality, along with tightening expectations and regulations for cell culture media. Cell culture media can be thought of as akin to engine oil, in that there are high demands on compliance as well as performance issues. Thus, during our development process, we grappled internally with the best product development to stay ahead of the curve, while dealing with the semantics of what is chemically defined media.
We chose to focus on three core concepts:
- Reproducibility: We wanted to develop a media that is consistent and enhances reproducibility for lab researchers.
- Friendly: We wanted to make our media as user-friendly as possible (no coating or supplements), reducing potential errors while handling.
- Performance: Our CellCor™ CD MSC is an expansion media, so we set out to make a media that expands MSCs faster and better, while maintaining MSC identity, on par or superior to FBS and/or serum-free media.
Fulfilling those requirements naturally led to us developing a media that is derived of all synthetics and recombinants, thus being chemically defined, where all ingredients have known chemical structures with a high degree of purity.
I can proudly say that our media checks the boxes above and it is also:
- Ideal for translational studies: As our media is chemically defined and free of serum derived products, it addresses lot variation concerns and there is minimized risk of animal derived contaminants, making it regulatory friendly. I like to think our media is ahead of the regulatory requirements curve.
- Cost effective: Our media works well without coating reagents, and we are working hard to position our media products and solutions to be feasible in cost.
- Optimal for Exosome/EV research: Since our media is chemically defined, it does not contain FBS nor hPL and their contaminating EV particles, thus minimizing background noise.
The ideal media should be consistent, reproducible, future regulatory compliant, and proficient in mass production. Starting potential translational research early with chemically defined media is a very important step in establishing best practices.
Cade Hildreth: Beyond GMP-grade chemically defined MSC media, what other types of products and services does XCell offer?
Uri Lee: Utilizing our proprietary CAMPs technology, we have since launched CellCor™ DPC (dermal papilla cell) and CellCor™ SFD KERA (keratinocyte) media, which are manufactured under GMP.
We also expect to commercially launch the following in the near-term:
- CellCor™ Exo CD: Media optimized for exosome (EV) R&D (expected in 4Q 2022)
- CellCor™ NK CD: NK cell media (expected in 4Q 2022)
- Celluty: Cosmetic raw ingredient for skin and hair (expected in 4Q 2022)
Aside from the cell culture media, we are currently manufacturing specigrab, a VTM (viral transport media), for COVID-19 testing.
We also offer media customization and optimization services. This can run from optimizing our media to certain processes, i.e., certain cell types, mass expansion through bioreactors, to developing media with specific channel partners and end-users, as well as co-development services.
We are evaluating leveraging our expertise in the culture of cells to offer cell culture process engineering services in the future.
Cade Hildreth: What types of customers does Xcell Therapeutics typically serve?
Uri Lee: Our customers are both research and industry based, so our decision to focus on chemically defined products and solutions reflects the fact that a lot of research activity is poised for translational research. Our main business is developing and manufacturing highly efficient customized cell culture media. Further down the line, we hope to provide cell culture process engineering services, as well as offer CDMO services.
Areas of particular interest are in gene modification, closed system bioreactors, EVs, and the whole 3D Organoid space. We also anticipate collaborating with world-known researchers and companies across cell banking, foodtech, and drug discovery.
To support translational research, we expect to have FDA DMFs and other global regulatory support files in place late this year. We anticipate having up to 3 IND filing here in Korea, and one internationally, with our CellCor™ CD MSC by end of this year. We are optimistically hoping to be able to support IND filings in North America, Europe, and Asia, by the end of 2023.
Cade Hildreth: I believe Xcell is also involved with exosome research. Is this correct, and if so, what is your involvement in this rapidly growing area?
Uri Lee: Yes, we are actively involved with exosome research. Extracellular vesicles (EVs) are produced and released on activation of cells. Exosomes in specific and are classified as having a diameter of 30-150 nm with a lipid bilayer membrane. FBS, human serum, as well as hPL derived cell culture media contain contaminating EV particles, increasing the risk of contamination when conducting exosome research. In addition, the animal derived components can lead to unwanted reactions, which can affect the results of the exosome research. For this reason, utilizing chemically defined media such as CellCor™ CD MSC is ideal.
We have received a lot of interest from companies and researchers within the exosome and EV space due to that fact. For this reason, are working closely with many researchers, as well as technology providers, such as EV isolation companies, therapeutics companies, and companies with specific cell populations
Cade Hildreth: In addition to cell culture media, Xcell Therapeutics is investigating the production of cultured (lab-grown) meat. What do you see as Xcell’s role within this emerging market area?
Uri Lee: As previously mentioned, we are engaged with a major food company to co-develop cultured meat. The project started last year.
Our role in this emerging market is our expertise in generating animal-free and chemically defined cell culture solutions. This applies to the R&D and production of media for the cultured meat industry, of which media is a key bottleneck, but also employing our expertise in cell culture and mass production to overcome hurdles within the industry.
Cade Hildreth: What are your five-year goals for Xcell?
Uri Lee: Since its establishment, Xcell’s goal and vision has been to establish industry leadership through the advancement of novel cell culture technology. Over the past 5 years, we have built our CAMPs technology to develop and manufacture highly efficient media.
Now that we have successfully commercialized our first product, CellCor™ CD MSC, we want to collaborate with global innovators and leaders, and to advance the research and development of the broader regenerative medicine market.
Over the next 5 years, we would like to become the global leader of ATMPs (Advanced Therapeutics Medicinal Products) and the front runner of cell culture CDMOs. By expanding our portfolio and introducing various needed types of cell culture media for the cell therapy market, we aim to achieve this goal. We also envision our applying our CAMPs technology to a broad range of other healthcare applications, including the cosmetic and foodtech industries.
Cade Hildreth: What types of partnerships and collaborations does Xcell currently have? What types would you be open to considering?
Uri Lee: We are open to all types of partnerships and collaborations. We are currently focused and are interested on the following:
- Supporting clinical translational research resulting in IND filings utilizing our solutions.
- Serving therapeutics companies within the MSC/Exosome/EV space.
- Offering OEM/ODM, CMO/CDMO cell culture media services.
- Optimization and collaboration with other technology vendors within the regenerative medicine space, including bioreactor companies, reagent companies, cultureware companies, and 3D printing, for example.