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 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 and 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 are also hosting a booth and giving a poster presentation at the ISCT 2022 Annual Meeting (International Society of Cell and Gene Therapy) in San Francisco, where we have already seen substantial interest in our products.
We have also 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. This 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 traceability issues. This was evidenced well with the supply shortage of hPL derived products during the Covid pandemic.
The ideal media should be chemically defined, with all components being 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 media 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.
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