Quality and Stability Testing of Oligonucleotide Medicines
We perform the quality and stability testing of oligonucleotide medicines requested by our clients from the early research and development stage to the commercial stage in accordance with regulatory requirements, such as GMP and the Japan’s Reliability Criteria*1.
Operation system
- We conduct our studies based on ICH guidelines.
- We conform to the Japan’s Reliability Criteria*1, and GMP (Japan, the USA, and the Europe).
- We comply with the Japanese and global laws, guidance, and guidelines and we ensure the data integrity *2.
Inspection and audit experience
- We have abundant experience in FDA inspections, PMDA inspections, QP audits, and audits by clients worldwide, including Japan.
Features
- In accordance with the current regulatory trends in the field of oligonucleotide medicines, such as “Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics”*3, we support our clients’ development of specifications and test methods for drug substances and drug products, taking into account the structures and properties of nucleic acid drugs, such as antisense oligonucleotide (ASO), siRNA and various ligand conjugates.
- We can perform impurity profiling with two-dimensional LC-MS/MS.
Quality testing and stability testing
- Long term testing, accelerated testing, stress testing, and photostability testing according to ICH Guidelines*4
- Stability storage facilities at our testing sites are monitored by centralized control systems (NASTER systems).
Samples handling
- Lyophilized nucleic acids are sensitive to humidity in the testing environment. We handle the samples in a humidity-controlled laminar flow cabinet.
- Powder containment facilities (EC2) enable our handling of highly potent compounds up to OEL Category 5.
- BSL-2 laboratories enable our handling of biohazard samples.
Test items
| Test items | Methods | Instruments |
|---|---|---|
| Description | Visual observation | - |
| Identification | Counter ions | ICP-MS, ICP-AES, IC |
| Melting temperature. (Tm) | UV with temperature control | |
| Molecular weight | IPRP-LC-UV-MS | |
| Purity | Oligonucleotide impurities | AEX-LC, SEC-LC |
| IPRP-LC-UV-MS | ||
| Residual solvents | GC, GC-MS, IC | |
| Elemental impurities | ICP-MS | |
| Assay | Content of oligonucleotide | IPRP-LC-UV-MS, UV, etc. |
| Water content | Vaporization-coulometric titration | KF moisture meter |
| pH | JP/USP/EP analytical method | pH meter |
| Microbial limit test | JP/USP/EP analytical method | - |
References
- *1: Article 43 of Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
- *2: FDA 21 CFR Part11
Notification by the Director General of the Pharmaceutical and Food Safety Bureau, MHLW Regarding Use of Electromagnetic Records and Electronic Signatures in Applications for Drug Approval or Licensing, etc. (PFSB Notification No. 0401022)
Annex11 to the EU Guide to GMP Computerized Systems
Notification " Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs" (Pharmaceutical and Food Safety Bureau, Pharmaceutical and Food Safety Bureau, MHLW, PFSB Notification No. 1021-11)
A risk-based Approach to Compliant GxP Computerized Systems (GAMP 5), ISPE/GAMP COP (2008.2) - *3: Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics
https://www.pmda.go.jp/files/000263163.pdf
https://www.pmda.go.jp/files/000263162.pdf - *4: ICH Guideline, Stability Assay
https://www.pmda.go.jp/int-activities/int-harmony/ich/0038.html (accessed 2025.11.28)
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