Sumitomo specializes in the contract manufacturing of gRNA for therapeutic applications, leveraging its unique technology to provide high-purity gRNA.
With our extensive array of analytical techniques, combined with over 50 years of GMP experience and unwavering commitment to quality, we offer comprehensive services tailored to meet your specific gRNA needs.
OUR SERVICE
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Large-Scale GMP Manufacturing
- Fully GMP-compliant state-of-the-art manufacturing plant located in Oita, Japan
- 90% purity @100 mer gRNA and 85% purity @130 mer gRNA
- Using Cytiva’s OligoPilot 400 synthesizer
- Product form: Frozen/Lyophilized solution
Small-Scale GMP Manufacturing
- Through an alliance partner, PeptiStar, Sumitomo can offer GMP gRNA using Cytiva’s OligoPilot 100 synthesizer.
- Manufacturing site located in Osaka, Japan
- Full technology transfer completed. Quality equivalent to that at Sumitomo’s site
- Sumitomo’s full oversight and responsibility for quality
Analytical method development and validation
- High-resolution HPLC method dedicated to gRNAs
- Prevalidated standard analytical method
- Validation service for sequence-specific methods
Stability Services
- In addition to the storage conditions recommended in the ICH guidelines (e.g., 5±3℃, -20±5℃), various temperature, such as -80℃ and 10±2℃, can also be accommodated.
- Photostability service are available under various lighting conditions, such D65, a cool white fluorescent lamp, and a near UV fluorescent lamp at controlled temperature range of 5 - 25℃.
- All stability services are in compliance with GMP.
Supply Chain Management
To offer stable and quick supply of products to its customers, Sumitomo's well-organized supply chain team has established a stable network.
1. Specialized Supply Chain Management for Raw Materials:
To secure stable and high-quality raw materials, Sumitomo’s supply chain management team regularly visit its suppliers, monitors their performance, and periodically conducts audits through an independent QA team. Additionally, we stock important raw materials within our facilities to maintain a stable supply in case of any disruptions.
2. Dual Sourcing for Each Raw Material:
We promote dual sourcing for each raw material. As a global chemical manufacturer within the Sumitomo Group, we leverage our worldwide network for procurement.
3. Transport Management in Compliance
We also offer delivery to your preferred locations. We implement strict temperature control and other measures to ensure that our products are delivered to our customers under desired conditions.