Sumitomo Chemical to Construct a New Manufacturing Plant for Nucleic Acid Drug Substances at Oita Works in Japan - Established the world's first^*1 large-scale production technology for high-purity gRNA for genome editing therapy -

Oct. 4, 2021

Sumitomo Chemical Co., Ltd. has established the world’s first^*1 large-scale production technology for guide RNA (gRNA) with a purity as high as approximately 90% for genome editing therapy, and will construct a new manufacturing plant for nucleic acid drug substances at its Oita Works (Oita City, Oita Prefecture, Japan). The plant is scheduled to come on stream in the middle of 2023. The Company’s production capacity will increase by about six times.

Nucleic acid drugs are middle molecule drugs that combine the features of small molecule drugs^*2, which can be produced by chemical synthesis, and antibody drugs^*3, which are large molecule drugs and which act on targets with high selectivity. They are attracting attention as next-generation medications that act on genes or proteins that cause diseases by leveraging the functions of DNA and RNA. Sumitomo Chemical started a contract manufacturing business for nucleic acid drug substances in 2013, based on its advanced organic synthesis technology and industrialization technology cultivated through the production of active pharmaceutical ingredients and intermediates for small molecule drugs. In recent years, the Company has been working on large-scale production of gRNA, a long-chain nucleic acid, for genome editing therapy.

Genome editing is a technology to modify a gene sequence at particular locations on chromosomes by using nucleases, enzymes for cutting nucleic acids. CRISPR-Cas9, a genome editing technology, which won the Nobel Prize in Chemistry in October 2020, is superior to other genome editing techniques in terms of cost, speed, and efficiency in editing genes, and is expected to be applied to the treatment of diseases that are difficult to cure with existing drugs. Treatment using CRISPR-Cas9 requires the Cas9 nuclease, which works like scissors as a DNA cleavage enzyme, and gRNA, a genetic material to guide Cas9 to the target gene, a material that is highly pure and has a chain a few times longer (approximately 100mer^*4) than existing nucleic acid drug substances. Sumitomo Chemical has established the world’s first technology for producing, on a large scale and in high yields, gRNA with a high purity of approximately 90%, as is required for CRISPR-Cas9 for therapeutic purposes. This achievement was considered difficult to achieve with existing chemical synthesis processes, and the Company has decided to construct a new manufacturing plant utilizing this technology.

The Sumitomo Chemical Group has positioned “accelerating the development of next-generation businesses” as a pillar of its basic policy under its Corporate Business Plan for FY2019 to 2021, and has been working to create new businesses in the four priority areas of reducing environmental impact, healthcare, food, and ICT. Building on this decision to construct a new facility, the Company will step up efforts to establish a firm position as a frontrunner in the manufacturing of gRNA for genome editing, an area where the market is expected to grow going forward, while also endeavoring to contribute to promoting genome editing therapy.

*1     Referring to a technology to produce gRNA with a high purity of approximately 90% on a large scale. Based on the results of a survey conducted by the Company, as of the date of announcement, October 4, 2021

*2     Small molecule drugs are produced by chemical synthesis and are currently the most widely used type of pharmaceuticals.

*3     Antibody drugs contain antibodies, which play a major role in the human immune system, as their active ingredient, and have few side effects due to their uniquely high specificity to targets. Antibody drugs still have some challenges to address: antibody drugs are difficult to manufacture on a large scale, and they cannot be administered orally.

*4     The term “mer” represents a unit of measurement that is used to indicate the number of nucleotides contained in a nucleic acid molecule. A nucleotide is the minimum constituent of a nucleic acid molecule.

Reference

Sumitomo Chemical nucleic acid drug substance information site
https://www.sumitomo-chem.co.jp/oligonucleotide/

Contact

Corporate Communications Dept.
27-1, Shinkawa 2-chome, Chuo-ku, Tokyo, 104-8260, Japan
TEL: +81-3-5543-5102 FAX: +81-3-5543-5901