Log inManufacturing & Safety
Manufacturing of Sonanos™:
Planning GMP Manufacturing in Compliance with IPEC-PQG
We have already established proprietary industrial manufacturing technology for Sonanos™ with the aim of commercialization.
We are currently planning GMP manufacturing of Sonanos™ in compliance with the international GMP guideline for pharmaceutical excipients, IPEC-PQG.
Additionally, to ensure safe use in injectable formulations, we plan to comply with the ICH-Q3 impurity guideline. If you have requirements beyond these standards, please consult with us.
Safety Data of Sonanos™
We possess non-GLP safety data for Sonanos™ PG (Sustained Release Grade) and Sonanos™ DS (Solubility Enhancement Grade). You can find the summary of the results in our letest Posters/presentations issued for conferences, which are available for download from our website upon free registration. For further details, please contact us. The CRO reports of in vivo testing are available under Confidential Disclosure Agreement (CDA).
In Vivo Testing (Non-GLP): CRO Reports Available Under CDA
Sonanos™ PG (Recommended Administration Route: SC)
| Test | Route | Animal |
|---|---|---|
| Single Dose Acute Toxicity & SC Tolerance Studies (Day 3 & Day 28) | SC | Rat |
| Single Dose Acute Toxicity (14 days) | SC | Rat |
| SC Tolerance Studies (Day 7 & Day 28 & Day 56) | SC | Rat |
| SC Tolerance Studies (Day 7 & Day 28) | SC | Monkey |
|
Single Dose Acute Toxicity (14 days) Note: One dose level study (CHHA 100 mg/kg/dose) to define Maximal Tolerable Dose (MTD). |
IV | Rat |
Sonanos™ DS (Recommended Administration Route: SC or IV)
| Test | Route | Animal |
|---|---|---|
| Single Dose Acute Toxicity (14 days) | IV | Rat |
|
Repeated-Dose Toxicity & Recovery Study *Treatment period: 14 days **Recovery period: 28 days |
IV | Rat |
|
Single Dose Acute Toxicity & SC Tolerance Studies (Day 7 & Day 28) Note: SC tolerance was also evaluated on Day 56 for the highest dose level. |
SC | Rat |
| SC Tolerance Studies (Day 7 & Day 28) | SC | Monkey |
In Vitro Testing (Non-GLP): Results Only
- Ames Test: Negative, indicating no mutagenic activity (Sonanos™ DS)
- Chromosomal Abnormalities: Testing did not induce structural or ploidy chromosomal abnormalities, suggesting genetic stability (Sonanos™ DS)
