RS Synthesis can provide cGMP peptide manufacturing according to FDA 21 CFR parts 210 & 211, following ICH Q7A Good Manufacturing Practices. FDA registered, dedicated facilities for API manufacturing, including both SOLID and SOLUTION phase synthesis, purification, lyophilization, and packaging are the foundation of the quality systems in place for GMP peptide production.
GLP services also available, if GMP peptide is not yet required, such as for animal tox studies. Class 300,000/100,000/10,000 clean rooms, and on-site water treatment facilities round out the comprehensive GMP Petpide and API manufacturing services offered. Site visits and audits welcomed, and facility layout diagrams can be provided upon request. Download our GMP/API Specification Check Sheet
5L to 350L+ Reaction Vessel Capacities available.
- Multi-gram, and multi-kg GMP peptide manufacturing expertise
- NEW – small scale GMP capacity (mg to g)
- 10 kg+ single lot capability (solid phase)
- Validated raw materials and equipment
- Custom and Standard CoA packages
- Specific Batch Records available (see Sample Technical Package)
- Wide array of QA testing available, typically including items listed below
- ICH storage and stability studies
|Appearance||Purity by gradient HPLC||MW by mass spec|
|Peptide content||Counter Ion content||Water content|
|Residual organic solvent content||Endotoxin|