Ajinomoto Co., Inc. to Confirm StemFit® AK03N, Cell Culture Medium
for Clinical Research, Performed iPS Cell Proliferation Proficiently
Cell and Gene Therapy Catapult conducted the comparative cultivation testing in
different culture systems
StemFit® AK03N
PS/ES cell culture medium
for clinical research
TOKYO, June 9, 2017 – Ajinomoto Co., Inc. (“Ajinomoto Co.”) confirmed that StemFit® AK03N, a cell culture medium for clinical research into regenerative medicine, showed superior cell proliferation performance compared with different products using iPS cells by Cell and Gene Therapy Catapult (“CGT Catapult”). By providing products with the world's highest-class performance, Ajinomoto Co. continues to contribute to the rapid realization of regenerative medicine around the world.

Regenerative medicine is considered to be one of the most thriving and advancing fields of research for both clinical and practical applications. The global market for peripheral regenerative medicine-related industries, such as equipment, supplies and services, was JPY 240 billion as of 2012, with the United States accounting for approximately half. By 2050, it is expected to grow to JPY 15 trillion (2013 Ministry of Economy, Trade and Industry survey).

In the FY2017-2019 Medium-Term Management Plan, Ajinomoto Co. set priority on the expansion of the portfolio of the AminoScience business by building new business pillars. As a new growth driver, Ajinomoto Co. is working on launching business in the advanced biopharmaceuticals such as cell culture medium and ingredients. Based on StemFit® AK03N successfully developed in collaboration with the Center for iPS Cell Research and Application at Kyoto University in 2014, Ajinomoto Co. has been selling StemFit® AK03N, cell culture medium for clinical research, widely in Japan since 2016. StemFit® AK03N is the cell culture medium that has been domestically approved for use in clinical research. It consists solely of refined substances completely free of animal- and human-derived components through the use of recombinant proteins made with biotechnology.

CGT Catapult is an independent center of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialization. The Industrialization group of CGT Catapult aims to develop cost-effective processing platforms for the commercial manufacture and industrialization of iPSC-derived cell therapy products. In this test, media of different formulations were compared with StemFit® AK03N for culture of iPS cells. As a result, iPS cells cultured with StemFit® AK03N performed not only with higher cell proliferation, but also showed characteristics such as homogeneity of gene expression compared with iPS cells cultured with 4 other media without any chromosomal abnormalities.

Evaluation of cell proliferation
The figure shows the average level of population doublings per day (PDL/day(d-1))

Ajinomoto Co. continues to promote the development of cell culture media for clinical research for the global market, and plans to roll out the StemFit® series in various countries.

By marketing StemFit® cell culture media for iPS/ES cells, the Ajinomoto Group will contribute to the realization of regenerative medicine and the development of new pharmaceuticals, and thus to healthy human lives.


■Product Overview
(1) Product name: StemFit® AK03N
(2) Features: A culture medium that enables maintenance and a high rate of expansion of undifferentiated iPS/ES cells. It offers both a high level of safety and a high proliferation rate for clinical research needs.
(3) Product format: Three component solutions to be mixed when used.
One set makes approximately 500 mL of culture medium.

■Overview of Cell and Gene Therapy Catapult
(1) Company name: Cell Therapy Catapult Ltd.
(Cell and Gene Therapy Catapult is a trading name of the company)
(2) Location: London, U.K.
(3) Established: 2012
(4) Representative: Keith Thompson, CEO
(5) Number of employees: More than 130 (as of May 31, 2017)
(6) Business description: Cell and Gene Therapy Catapult was established as an independent center of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialization. It works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialize these advanced therapies. Cell and Gene Therapy Catapult is supported by Innovate UK. Innovate UK is an executive non-departmental public body, sponsored by the Department for Business, Energy & Industrial Strategy.
(7) URL: https://ct.catapult.org.uk/

■Press Release from Cell and Gene Therapy Catapult., June 8th, 2017
Title: CCell and Gene Therapy (CGT) Catapult Licenses Cell Culture Data to Ajinomoto Co., Inc.
URL: https://ct.catapult.org.uk/news-media/general-news/press-release-cell-and-gene-therapy-catapult-licenses-cell-culture-data


iPS cell:
Induced pluripotent stem cell. A cell made by introducing various types of reprogramming factors into human somatic cells. iPS cells can differentiate into various tissue and organ cells and proliferate indefinitely in culture.

ES cell:
Embryonic stem cell. A stem cell derived from the inner cell mass of a human blastocyst (a very early embryo) that is capable of differentiating into the various tissue and organ cells that make up the body.

Recombinant proteins:
Proteins created with biotechnology using microbes, yeast or other substances. Recombinant proteins are widely used as biopharmaceuticals, including treatments for cancer and rheumatism.

Homogeneity of gene expression:
A state suggesting that the gene expression, an indicator of cell properties, is uniform, and the cell properties are stable during culture. Changes in the iPS cells properties during culture are regarded as a major challenge towards the realization of regenerative medicine; thus, a high-quality culture system is required to stabilize the cell properties.

About Ajinomoto Co.
Ajinomoto Co. is a global manufacturer of high-quality seasonings, processed foods, beverages, amino acids, pharmaceuticals and specialty chemicals. For many decades Ajinomoto Co. has contributed to food culture and human health through wide-ranging application of amino acid technologies. Today, the company is becoming increasingly involved with solutions for improved food resources, human health and global sustainability. Founded in 1909 and now operating in 30 countries and regions, Ajinomoto Co. had net sales of JPY 1,091.4 billion (USD 10.07 billion) in fiscal 2016. For more about Ajinomoto Co. (TYO: 2802), visit www.ajinomoto.com.

For further information, please contact:
Ajinomoto Co., Inc. Public Communications Department; pr_info@ajinomoto.com