PI
PeptiStar Inc.
CDMO · Settsu, Osaka, Japan
GMP
Overview
PeptiStar, established on 1 September 2017 in Settsu, Osaka, researches, develops, manufactures and sells special peptide APIs and oligonucleotide APIs. It offers analytical work and support for clinical trials and approval filings. Its methods include microwave solid-phase synthesis, STag-PS and SYNCSOL, continuous chromatography and stirred freeze-drying. The site has a 300 L reaction filter and a 500 L freeze dryer and supports work from a few milligrams to tens of kilograms of GMP material.
Capabilities
- Peptide API development and GMP manufacture
- Microwave solid-phase synthesis
- Continuous chromatography purification
- Lyophilisation
- Regulatory filing support
Quality signals
| GMP evidence | Yes |
|---|---|
| Certificates of analysis | Not found |
| Third-party testing | Not found |
| ISO certification | Not found |
| Makes own product | Yes, in-house production |