GMP Grade mRNA Manufacturing
Facilities and environment
World-class manufacturing environment (cGMP compliant)
Our facilities are fully compliant with the pharmaceutical manufacturing and quality control standards (cGMP), and we conduct process verification based on “Quality by Design,” which incorporates quality from the design stage. This ensures consistent high quality and safety.
Data integrity
Manufacturing records and quality data are strictly managed using an electronic document management system compliant with 21 CFR Part 11. We ensure data reliability and transparency and are prepared for future web audits. We provide peace of mind to our customers.
Rapid support from domestic locations
With manufacturing facilities located in Japan, we enable seamless communication and swift responses without time zone differences. We promptly address customer requests and provide robust support for research and development.
High-purity cleanroom (ISO Class 7 / Grade C)
We minimize particulate and microbial contamination in an ISO Class 7-compliant cleanroom suitable for RNA synthesis. We manufacture stable, high-purity RNA products.
Aseptic filling system (ISO Class 5 isolator)
Filling processes are conducted in an isolator system that boasts the highest level of sterile environment (ISO Class 5/Grade A). We provide safe products under strict sterile management.
Enhanced quality control system (GLP-compliant analysis)
We are progressively introducing GLP-compliant analytical equipment and establishing various test items. By leveraging the latest analytical technologies, we aim to establish a more precise quality evaluation and improvement cycle.
| Item | Specifications / Details |
|---|---|
| Manufacturing history documents | cGMP compliant |
| Manufacturing environment | mRNA manufacturing: ISO Class 7 Aseptic filling: ISO Class 5 |
| Raw material management | Traceable, supplier management |
| Manufacturing scale | 100 mg to 50 g |
Quality Contorol
| Quality | Attribute | Method | Preclinical | cGMP Compliant | |
|---|---|---|---|---|---|
| Identity | Sequence Confirmation | Sanger Sequencing | OK | OK | |
| Content | RNA Quantification | UV Absorbance | OK | OK | |
| Integrity | mRNA Integrity | Capillary Gel Electrophoresis (CGE) | OK | OK | |
| Purity | Purity Confirmation | RP-HPLC | - | OK | |
| 5’ Capping Efficiency | LC-MS | OK | OK | ||
| 3’ poly(A) Tail Length | LC-MS | OK | OK | ||
| Impurities originating from the product | dsRNA | ELISA | OK | OK | |
| Aggregates | SEC-HPLC | - | OK | ||
| Short Fragment Insertion Rate | RP-HPLC | - | OK | ||
| Residual DNA Template | qPCR | OK | OK | ||
| Residual Nucleotides | LC-MS | - | OK | ||
| Residual Reagents | Anion exchange-HPLC | - | OK | ||
| Residual T7 Polymerase | ELISA | OK | OK | ||
| Potency | Protein Expression | Cellular transfection and evaluation | OK | OK | |
| Safety | Endotoxin Test | USP <85>、JP<4.01> | OK | OK | |
| Microbial Limit Test | USP <61>, <62>, <1115> JP<4.05> | OK | OK | ||
| Other | Visual Inspection | USP <790> | OK | OK | |
| Residual Solvent | USP <467>、JP<2.46> | OK | OK | ||
| pH | USP <791>、JP<2.54> | OK | OK | ||
Ref. : Analytical Procedures for Quality of mRNA Vaccines and Therapeutics (Draft Guidelines: 3rd Edition)
*Please contact us if you would like additional quality control and evaluation.