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Sumitomo Chemical Establishes a CRO for Oligonucleotide CDMO Business in U.S.
Apr. 2, 2025
On April 1, 2025, Sumitomo Chemical established a new company, Sumitomo Chemical Advanced Medical Solutions America LLC (“SC-AMSA”), in Marlborough, Massachusetts, the United States. This company will serve as a CRO*1 for Sumitomo Chemical’s Oligonucleotide CDMO*2 business. SC-AMSA plans to begin providing samples to customers by August 2025.
Sumitomo Chemical began its nucleic acid drug substance contract manufacturing business in 2013. Recently, it has focused on the large scale production of long-chain oligonucleotides called gRNA, which are necessary for genome editing therapy. The Company has established the world’s first technology to produce at scale long-chain gRNAs that are several times longer (approximately 100 mer*3) than conventional nucleic acid drug substances, with high purity of approximately 90% and high yield*4 A new manufacturing plant for the gRNA was established at Sumitomo Chemical’s Oita Works in Japan, and shipments to multiple customers began in fiscal 2024.
SC-AMSA is located in Marlborough, which is close to Boston, Massachusetts, where there is a large concentration of drug discovery start-up companies with high demand for gRNA. Sumitomo Chemical will provide gRNA samples from this strategically located new company to closely communicate with customers and promptly respond to their needs.
In its medium- to long-term strategy, the Sumitomo Chemical Group is committed to solving societal issues in the four fields of food, ICT, healthcare, and the environment, by leveraging its innovative technologies. The Group’s growth areas are agriculture-related and ICT-related businesses, which the Group has positioned as its current growth drivers. The Advanced Medical Solutions Sector, the next growth area following these businesses, was established in October of last year. The sector provides solutions for advanced medical treatments, including oligonucleotides, active pharmaceutical ingredients for small-molecule drugs, and regenerative medicine and cell therapy products. Sumitomo Chemical will work to enhance SC-AMSA’s functions and operations as a foothold to develop its Oligonucleotide CDMO business in the United States, the world’s largest pharmaceutical market. The Company will also explore the possibility of business expansion to grow its advanced small molecule drug CDMO business and regenerative medicine and cell therapy business in the United States.
*1 CRO is an acronym of Contract Research Organization.
*2 CDMO is an acronym of Contract Development and Manufacturing Organization, a business that undertakes process development and manufacturing for customers. Sumitomo Chemical operates CDMO businesses related to active pharmaceutical ingredients and intermediates for small molecule drugs, oligonucleotides, and regenerative medicine and cell therapy.
*3 The term mer represents a unit of measurements 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.
*4 Sumitomo Chemical’s technology was the first to large-scale-produce gRNA with approximately 90% purity as of its announcement of this achievement on October 4, 2021. Source: Sumitomo Chemical’s research.
Overview of the New U.S. Company
| Name | Sumitomo Chemical Advanced Medical Solutions America LLC |
|---|---|
| Location | Marlborough, Massachusetts, USA |
| Established | April 1, 2025 |
| President | Katsuyuki Imada |
| Business | Sales and sample production for Oligonucleotide CDMO business |
| Equity ratio |
Sumitomo Chemical Co., Ltd.: 99% |
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