TOPNewsFiscal 2023Result of NEDO Smart Cell Project leads to commercial product

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Result of NEDO Smart Cell Project leads to commercial product

Contributing to dyslipidemia testing through supply of material for in vitro diagnostic assays

June 30, 2023
Asahi Kasei Pharma Corp.
National Institute of Advanced Industrial Science and Technology
New Energy and Industrial Technology Development Organization

Asahi Kasei Pharma and the National Institute of Advanced Industrial Science and Technology (AIST) worked together as part of the Smart Cell Project of the New Energy and Industrial Technology Development Organization (NEDO) to raise the production efficiency of cholesterol esterase, an enzyme used as a material for in vitro diagnostic assays. The result of this effort has enabled the manufacture of a commercial product of cholesterol esterase (product name: CEN II) which is scheduled to be launched on June 30, 2023.

The smart cell that was created produces more than 30 times the amount of cholesterol esterase than the wild-type strain. Such a high-productivity strain could not be obtained by conventional methods. Asahi Kasei Pharma looks forward to supporting the testing for dyslipidemia through the supply of CEN II as a material for in vitro diagnostic assays worldwide.

1. Efforts in the NEDO Smart Cell Project

NEDO, Asahi Kasei Pharma, and AIST performed a Smart Cell Project1 where highly functional chemicals etc. are produced with energy conservation at low cost by utilizing smart cells, which are artificially modified biological cells whose material production capabilities are maximized. Through the commissioned period2 from fiscal 2016 to 2018 and the subsidized period3 from fiscal 2019 to 2020, the project focused on raising the production efficiency of cholesterol esterase4, an enzyme used as a material for diagnostic assays of blood cholesterol level.

In 2021, the project succeeded in creating a smart cell of the microorganism Burkholderia stabilis that produces cholesterol esterase. With this smart cell, it became possible to raise the production of cholesterol esterase to more than 30 times that of the wild strain, although this could only be raised by a factor of approximately 2.8 using conventional methods. This was the world’s first creation of a smart cell highly productive of cholesterol esterase, which enables high productivity at lower cost than the conventional process. Furthermore, as power consumption in the production process is reduced, carbon dioxide (CO2) emissions are expected to decrease by some 23 tons annually (approximately 96% reduction from the conventional process).

2. Commercialization of cholesterol esterase product (CEN II)

Asahi Kasei Pharma advanced product development of cholesterol esterase produced using the smart cell created in the NEDO project. This led to successful commercialization of a product (product name: CEN II), which is scheduled to be launched on June 30, 2023. Growing health awareness worldwide has raised demand for dyslipidemia5 tests and their in vitro diagnostic assays, which is expected to lead to further demand for material used in these assays. Asahi Kasei Pharma looks forward to supporting the testing for dyslipidemia by supplying CEN II as a material for in-vitro diagnostic assays worldwide.

3. Moving forward

Asahi Kasei Pharma aims to realize a society where “no one should have to give up doing what they love due to illness” in accordance with its mission “to sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science” by contributing to various diagnoses and the treatment of various diseases through R&D of products and technologies that meet the needs of the times. See the Diagnostics Division Website of Asahi Kasei Pharma for more information.

AIST aims to promote healthy longevity and environmentally friendly bioeconomy to realize a prosperous, lively, and sustainable society while contributing to R&D in medical devices and healthcare that incorporate biological mechanisms, regenerative and omics-based therapy, medical substance manufacturing, and functional biologics production by forming a platform consisting of fundamental medical technology, based on advanced analysis, together with biomanufacturing technology.

NEDO is advancing a Bio-manufacturing Project6 which aims to industrialize products manufactured by using smart cells, and to nurture biomanufacturing human resources, as a successor to the Smart Cell Project. NEDO seeks to invigorate Japan’s bioeconomy by accelerating the practical application of bio-based products, while contributing to the realization of carbon neutrality in 2050 by reducing GHG emissions.

  • 1Smart Cell Project
    Project name
    Development of Production Techniques for Highly Functional Biomaterials Using Plant and Other Organism Smart Cells
    Period
    FY2016–2021
    https://www.nedo.go.jp/english/activities/activities_ZZJP_100118.html
  • 2Commissioned work
    Project name
    Development of Production Techniques for Highly Functional Biomaterials Using Plant and Other Organism Smart Cells / Development of information analysis system useful for creating highly productive microorganisms (subject: Verification of effectiveness of productivity improvement of cholesterol esterase)
    Period
    FY2016–2018
    Consignee
    Asahi Kasei Pharma Corp.
    Joint research
    National Institute of Advanced Industrial Science and Technology
  • 3Subsidized work
    Project name
    Development of Production Techniques for Highly Functional Biomaterials Using Plant and Other Organism Smart Cells / Development of production technology for highly functional products using microorganism / Development of cholesterol esterase from recombinant Burkholderia stabilis
    Period
    FY2019–2020
    Grantee
    Asahi Kasei Pharma Corp.
    Joint research
    National Institute of Advanced Industrial Science and Technology
  • 4Cholesterol esterase is an enzyme that catalyzes the hydrolysis of cholesterol esters
  • 5Dyslipidemia is a condition of abnormal blood lipid levels. Lipid abnormalities include abnormal blood levels of LDL cholesterol (so-called bad cholesterol), HDL cholesterol (so-called good cholesterol), and triglycerides (neutral fat), all of which are associated with accelerated arteriosclerosis.
  • 6Bio-manufacturing Project
    Project name
    Development of bio-based production technology to accelerate Carbon Recycling
    Period
    FY2020–2026