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Interview with Uri Lee, CEO of Xcell Therapeutics By Cade Hildreth
2022.04.29
Interview with
Uri Lee, CEO of Xcell Therapeutics
April 29, 2022 By Cade
Hildreth (CEO) Leave
a Comment
This is an
interview with Uri Lee, CEO of Xcell Therapeutics. Xcell Therapeutics 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 manfuctured 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.
Cade Hildreth: How
can people get in touch with you or learn more about Xcell Therapeutics?
Uri Lee: You can always drop us an e-mail at info@xcell.co.kr or visit us at our website xcell.media.
4.6/5 - (71 votes)
Filed Under: Cell
Therapy, Exosomes, Interviews, Stem
Cell News
About Cade
Hildreth (CEO)
Cade
Hildreth is the Founder of BioInformant.com, the world's largest
publisher of stem cell industry news. Cade is a media expert on stem
cells, recently interviewed by the Wall Street Journal, Los Angeles
Business Journal, Xconomy, and Vogue Magazine.