Oligo manufacturing

Development of the Manufacturing Process for Oligonucleotides

Sumitomo Chemical began its activities in oligonucleotide production in 2014 and has since been continuously expanding its manufacturing capabilities by investing in the development of innovative synthesis methodology. Sumitomo Chemical lends extensive support to its customers’ process development work by developing analytical methods, performing stability studies, and providing regulatory support, which results in a competitive advantage for its customers throughout the product lifecycle.
Sumitomo Chemical offers manufacturing capacities for flexible, cost-efficient production, from small-scale lab samples (mg) to large-scale production samples (several grams to kilograms per year).

・Oligonucleotide Manufacturing
- RNAi,ASO,aptamer
- small scale sample (mg)
- large scale production (kg/y)
・Long Chain RNA (over 40mer)
- Bonac RNA
- Pre-miRNA etc...
・Supply Chain management
- Amidites
- Other Starting Materials
- Reagents
・Chemical Development
- Process Development
- Process Optimization, Scale-Up
- Process Validation
・Analytical Method Development
・CMC supports
・GMP manufacturing

Manufacturing of Bonac Nucleic Acid

In 2013, Sumitomo Chemical obtained an exclusive license from the emerging Japanese biotech company, Bonac Co., Ltd., for the manufacture and sale of BONAC-type nucleic acid API (“Bonac Nucleic Acid”) and became Bonac’s partner in the development and manufacture of various Bonac nucleic acids. (→Links )

Development of manufacturing method and quality control of raw materials

The quality of the raw materials is very important for synthesizing oligonucleotides of consistently high quality. By taking advantage of our extensive experience in organic synthesis, accumulated over 40 years of process development for advanced intermediates and APIs, Sumitomo Chemical has established and manages a reliable supply chain of high-quality raw materials.

Regulatory Support

Sumitomo Chemical has a long track record of registering Drug Master Files (DMF) of small molecule APIs and intermediates and has extensive experience writing CMC sections for customers’ regulatory filings.